<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03036891</url>
  </required_header>
  <id_info>
    <org_study_id>24102</org_study_id>
    <nct_id>NCT03036891</nct_id>
  </id_info>
  <brief_title>Naloxegol for Opioid-Related Gastroparesis</brief_title>
  <official_title>Naloxegol for Opioid-Related Gastroparesis: A Double-Blind Study With an Open Label Extension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Temple University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Temple University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the effects of naloxegol (a peripheral mu-opioid&#xD;
      receptor antagonist [PAMORA]) in opioid-related gastroparesis on 1) symptoms of&#xD;
      gastroparesis; 2) gastric emptying; and 3) pain control. The endpoints will be gastroparesis&#xD;
      symptoms (PAGI-SYM), gastric emptying (GEBT), and pain control (McGill Pain Inventory). The&#xD;
      hypothesis to be tested is that naloxegol improves symptoms of gastroparesis in patients who&#xD;
      are taking opioids as well as improves their gastric emptying while maintaining control of&#xD;
      patient's pain. This study will entail an initial double-blind, randomized,&#xD;
      placebo-controlled, 4-week treatment period of naloxegol vs placebo in patients with&#xD;
      opioid-related gastroparesis followed by a 4-week open label period to demonstrate the&#xD;
      improvement in symptoms and gastric emptying with naloxegol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medicines can delay gastric emptying and produce similar symptoms to gastroparesis. In&#xD;
      particular, narcotic analgesics, can produce a gastroparesis picture, by delaying gastric&#xD;
      emptying. The slowing effect of opioids on gastric, small bowel, and colonic motility has&#xD;
      been well characterized. Unfortunately, many of these patients cannot stop their pain&#xD;
      medications due to their underlying condition, such as back pain, fibromyalgia. On top of&#xD;
      this, the narcotics can reduce the effectiveness of prokinetics agents used to treat&#xD;
      gastroparesis, such as metoclopramide and domperidone. At this time, there is no good&#xD;
      treatment for gastroparesis, especially for opioid-related gastroparesis.&#xD;
&#xD;
      Data suggests a relationship between opioid use and decreased gastric motility. Literature&#xD;
      suggests that peripherally acting opioid agonist may provide relief in the instance of GI&#xD;
      dysfunction (Holzer 2007). Movantik (Naloxegol) is an opioid agonist specifically designed to&#xD;
      work outside of the central nervous system. Movantik (Naloxegol) can alleviate the adverse&#xD;
      effects associated in chronic pain patients on opioid treatment - reduction of the undesired&#xD;
      peripheral effects of opioids without disrupting analgesic effects. The use of Movantik&#xD;
      (Naloxegol) has the potential to improve gastric dysmotility while preserving pain relief of&#xD;
      the opioid analgesic.&#xD;
&#xD;
      The objective of this study is to evaluate the effects of naloxegol in opioid-related&#xD;
      gastroparesis. This will be a randomized, double-blind study comparing Movantik 25 mg to&#xD;
      placebo. The dose of Movantik is the dose that is currently FDA approved for opioid-induced&#xD;
      constipation. The four-week study period is the duration of the phase 2b studies for Movantik&#xD;
      for opioid-induced constipation in which the response rates were 60% and 35% with active&#xD;
      treatment and placebo (Chey 2015).&#xD;
&#xD;
      The investigators have included a unique aspect of this study to better balance the benefits&#xD;
      for patients participating in this randomized double-blind study in which half the patients&#xD;
      receive a placebo agent. All patients in the treatment group and the placebo group will be&#xD;
      invited to participate in the 4-week open-label extension for this study. This also serves to&#xD;
      study the duration of the potential favorable effects of Movantik (Naloxegol) in this patient&#xD;
      population as well as offering an extended time period to assess safety and tolerability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Actual">December 29, 2016</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The investigators have included a unique aspect of this study to better balance the benefits for patients participating in this randomized double-blind study in which half the patients receive a placebo agent. All patients in the treatment group and the placebo group will be invited to participate in the 4-week open-label extension for this study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gastric Emptying (GE t-1/2)</measure>
    <time_frame>4 week</time_frame>
    <description>Improvement in gastric emptying (GE t-1/2) compared to Placebo</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Daily Symptom Improvement using the GCSI-DD (Gastroparesis Cardinal Symptom Index-Daily Diary)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Improvements of gastroparesis symptoms using the GCSI-DD (Gastroparesis Cardinal Symptom Index-Daily Diary)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Improvement using PAGI-SYM</measure>
    <time_frame>4 weeks</time_frame>
    <description>Improvements of gastroparesis symptoms using PAGI-SYM</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Management using the McGill Pain Inventory</measure>
    <time_frame>4 weeks</time_frame>
    <description>Changes in pain control using the McGill Pain Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall improvement in Gastric Emptying (GE t-1/2)</measure>
    <time_frame>8 week</time_frame>
    <description>Improvement in gastric emptying (GE t-1/2) compared to Placebo</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life based on SF-36</measure>
    <time_frame>4 weeks</time_frame>
    <description>QOL score changes based on SF-36</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Gastroparesis</condition>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Naloxegol 25 mg, oral tablet, daily for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Oral Tablet, 25 mg, oral tablet, daily for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Naloxegol 25 MG Oral Tablet [Movantik]</intervention_name>
    <description>Patients will be given the study drug (Movantik 25 mg).They will take this daily in the morning 1 hour before breakfast for four weeks.</description>
    <arm_group_label>Study Group</arm_group_label>
    <other_name>Study</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Patients will be given Placebo (Placebo 25 mg).They will take this daily in the morning 1 hour before breakfast for four weeks.</description>
    <arm_group_label>Placebo Control</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-84, Males or Females&#xD;
&#xD;
          2. Daily use of narcotic analgesics for treatment of pain. Patients need to be on a&#xD;
             stable daily dose of opiates for the last 4 weeks prior to enrollment&#xD;
&#xD;
          3. Patients with symptoms of gastroparesis with GCSI score (from the PAGI-SYM) of &gt;2.0.&#xD;
             These symptoms of gastroparesis must be present after starting opioid treatment.&#xD;
&#xD;
          4. Delayed gastric emptying based on previous scintigraphy (Percent gastric retention&#xD;
             &gt;60% at 2 hours and/or &gt;10% retention at 4 hours&#xD;
&#xD;
          5. Signing informed consent prior to any study specific procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior gastric resective surgery such as bariatric surgery, antrectomy.&#xD;
&#xD;
          2. Presence of severe renal impairment (CrCl&lt;60 ml/min)&#xD;
&#xD;
          3. Presence of severe hepatic impairment - Child-Pugh Classification Class C, generally&#xD;
             AST&gt;200 or ALT&gt;200 or Total bilirubin &gt;3.0.&#xD;
&#xD;
          4. Other conditions besides gastroparesis that could potentially slow gastric emptying,&#xD;
             such as untreated hypothyroidism.&#xD;
&#xD;
          5. Concomitants use of strong CYP 3A4 inhibitors (such as ketoconazole, diltiazem,&#xD;
             erythromycin, clarithromycin), use of CYP3A4 inducer.&#xD;
&#xD;
          6. Use of NSAIDs and/or Plavix/Clopidogrel&#xD;
&#xD;
          7. Any prior use of Movantik (the study drug) or other opioid receptor antagonist (e.g.,&#xD;
             Relistor (methylnaltrexone), naltrexone, or naloxone) before the screening visit.&#xD;
&#xD;
          8. Patients with known cancer or cancer history within last 5 years prior to the&#xD;
             screening visit.&#xD;
&#xD;
          9. Patients with GI obstruction and/or perforation or conditions with potential for GI&#xD;
             perforation.&#xD;
&#xD;
         10. Patients with disruption to the blood-brain barrier;&#xD;
&#xD;
         11. Current use of a medication affecting gastric motility such as metoclopramide,&#xD;
             domperidone, and erythromycin;&#xD;
&#xD;
         12. Pregnant women, females planning to become pregnant, and nursing mothers.&#xD;
&#xD;
         13. Women of childbearing potential who are unwilling to use contraceptives throughout the&#xD;
             course of treatment&#xD;
&#xD;
         14. Subjects with severe co-morbidities (Cardiovascular, respiratory, renal, hepatic,&#xD;
             hematologic, endocrine, neurologic) based on PI's clinical judgment.&#xD;
&#xD;
         15. Active substance abuse.&#xD;
&#xD;
         16. History of major comorbid psychiatric conditions including mania and schizophrenia or&#xD;
             severe current depression&#xD;
&#xD;
         17. At-risk populations, including prisoners and mentally challenged. Any condition or the&#xD;
             patient is in a situation which may put him/her at significant risk, may confound the&#xD;
             study results, or may interfere significantly with the subject's participation in the&#xD;
             study (e.g., difficulty hearing, cognitive impairment)&#xD;
&#xD;
         18. Patients in which Movantik is clinically inadvisable&#xD;
&#xD;
         19. Subject unable to consent or is unwilling to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>84 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henry Parkman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Temple University Hospita</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lewis Katz School of Medicine at Temple University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Parkman HP, Hasler WL, Fisher RS; American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology. 2004 Nov;127(5):1592-622. doi: 10.1053/j.gastro.2004.09.055.</citation>
    <PMID>15521026</PMID>
  </reference>
  <reference>
    <citation>Abell TL, Bernstein RK, Cutts T, Farrugia G, Forster J, Hasler WL, McCallum RW, Olden KW, Parkman HP, Parrish CR, Pasricha PJ, Prather CM, Soffer EE, Twillman R, Vinik AI. Treatment of gastroparesis: a multidisciplinary clinical review. Neurogastroenterol Motil. 2006 Apr;18(4):263-83. doi: 10.1111/j.1365-2982.2006.00760.x.</citation>
    <PMID>16553582</PMID>
  </reference>
  <reference>
    <citation>Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Calles J, Abell TL, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F; National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium. Similarities and differences between diabetic and idiopathic gastroparesis. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1056-64; quiz e133-4. doi: 10.1016/j.cgh.2011.08.013. Epub 2011 Aug 24.</citation>
    <PMID>21871247</PMID>
  </reference>
  <reference>
    <citation>Anantharamu T, Sharma S, Gupta AK, Dahiya N, Singh Brashier DB, Sharma AK. Naloxegol: First oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. J Pharmacol Pharmacother. 2015 Jul-Sep;6(3):188-92. doi: 10.4103/0976-500X.162015.</citation>
    <PMID>26312011</PMID>
  </reference>
  <reference>
    <citation>Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.</citation>
    <PMID>24896818</PMID>
  </reference>
  <reference>
    <citation>Revicki DA, Rentz AM, Dubois D, Kahrilas P, Stanghellini V, Talley NJ, Tack J. Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index. Aliment Pharmacol Ther. 2003 Jul 1;18(1):141-50. doi: 10.1046/j.1365-2036.2003.01612.x.</citation>
    <PMID>12848636</PMID>
  </reference>
  <reference>
    <citation>Revicki DA, Rentz AM, Tack J, Stanghellini V, Talley NJ, Kahrilas P, De La Loge C, Trudeau E, Dubois D. Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol. 2004 Sep;2(9):769-77. doi: 10.1016/s1542-3565(04)00348-9.</citation>
    <PMID>15354277</PMID>
  </reference>
  <reference>
    <citation>Revicki DA, Camilleri M, Kuo B, Norton NJ, Murray L, Palsgrove A, Parkman HP. Development and content validity of a gastroparesis cardinal symptom index daily diary. Aliment Pharmacol Ther. 2009 Sep 15;30(6):670-80. doi: 10.1111/j.1365-2036.2009.04078.x. Epub 2009 Jun 25.</citation>
    <PMID>19558608</PMID>
  </reference>
  <reference>
    <citation>Abell TL, Camilleri M, Donohoe K, Hasler WL, Lin HC, Maurer AH, McCallum RW, Nowak T, Nusynowitz ML, Parkman HP, Shreve P, Szarka LA, Snape WJ Jr, Ziessman HA; American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. J Nucl Med Technol. 2008 Mar;36(1):44-54. doi: 10.2967/jnmt.107.048116. Epub 2008 Feb 20.</citation>
    <PMID>18287197</PMID>
  </reference>
  <reference>
    <citation>Maranki JL, Lytes V, Meilahn JE, Harbison S, Friedenberg FK, Fisher RS, Parkman HP. Predictive factors for clinical improvement with Enterra gastric electric stimulation treatment for refractory gastroparesis. Dig Dis Sci. 2008 Aug;53(8):2072-8. doi: 10.1007/s10620-007-0124-7. Epub 2007 Dec 14.</citation>
    <PMID>18080765</PMID>
  </reference>
  <reference>
    <citation>Szarka LA, Camilleri M, Vella A, Burton D, Baxter K, Simonson J, Zinsmeister AR. A stable isotope breath test with a standard meal for abnormal gastric emptying of solids in the clinic and in research. Clin Gastroenterol Hepatol. 2008 Jun;6(6):635-643.e1. doi: 10.1016/j.cgh.2008.01.009. Epub 2008 Apr 14.</citation>
    <PMID>18406670</PMID>
  </reference>
  <reference>
    <citation>Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.</citation>
    <PMID>1235985</PMID>
  </reference>
  <reference>
    <citation>Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.</citation>
    <PMID>3670870</PMID>
  </reference>
  <reference>
    <citation>Culpepper-Morgan JA, Inturrisi CE, Portenoy RK, Foley K, Houde RW, Marsh F, Kreek MJ. Treatment of opioid-induced constipation with oral naloxone: a pilot study. Clin Pharmacol Ther. 1992 Jul;52(1):90-5. doi: 10.1038/clpt.1992.106.</citation>
    <PMID>1623695</PMID>
  </reference>
  <reference>
    <citation>Wesson DR, Ling W. The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive Drugs. 2003 Apr-Jun;35(2):253-9. doi: 10.1080/02791072.2003.10400007.</citation>
    <PMID>12924748</PMID>
  </reference>
  <reference>
    <citation>Peachey JE, Lei H. Assessment of opioid dependence with naloxone. Br J Addict. 1988 Feb;83(2):193-201. doi: 10.1111/j.1360-0443.1988.tb03981.x. No abstract available.</citation>
    <PMID>3345396</PMID>
  </reference>
  <reference>
    <citation>Tompkins DA, Bigelow GE, Harrison JA, Johnson RE, Fudala PJ, Strain EC. Concurrent validation of the Clinical Opiate Withdrawal Scale (COWS) and single-item indices against the Clinical Institute Narcotic Assessment (CINA) opioid withdrawal instrument. Drug Alcohol Depend. 2009 Nov 1;105(1-2):154-9. doi: 10.1016/j.drugalcdep.2009.07.001. Epub 2009 Aug 3.</citation>
    <PMID>19647958</PMID>
  </reference>
  <reference>
    <citation>Gandek B, Sinclair SJ, Kosinski M, Ware JE Jr. Psychometric evaluation of the SF-36 health survey in Medicare managed care. Health Care Financ Rev. 2004 Summer;25(4):5-25.</citation>
    <PMID>15493441</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>January 27, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>August 25, 2020</last_update_submitted>
  <last_update_submitted_qc>August 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gastroparesis</keyword>
  <keyword>Opioid-Induced</keyword>
  <keyword>Delayed Gastric Emptying</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Naloxegol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03036891
org study id: 24102
nct id: NCT03036891
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The objective of this study is to evaluate the effects of naloxegol (a peripheral mu-opioid
      receptor antagonist [PAMORA]) in opioid-related gastroparesis on 1) symptoms of
      gastroparesis; 2) gastric emptying; and 3) pain control. The endpoints will be gastroparesis
      symptoms (PAGI-SYM), gastric emptying (GEBT), and pain control (McGill Pain Inventory). The
      hypothesis to be tested is that naloxegol improves symptoms of gastroparesis in patients who
      are taking opioids as well as improves their gastric emptying while maintaining control of
      patient's pain. This study will entail an initial double-blind, randomized,
      placebo-controlled, 4-week treatment period of naloxegol vs placebo in patients with
      opioid-related gastroparesis followed by a 4-week open label period to demonstrate the
      improvement in symptoms and gastric emptying with naloxegol.
Medicines can delay gastric emptying and produce similar symptoms to gastroparesis. In
      particular, narcotic analgesics, can produce a gastroparesis picture, by delaying gastric
      emptying. The slowing effect of opioids on gastric, small bowel, and colonic motility has
      been well characterized. Unfortunately, many of these patients cannot stop their pain
      medications due to their underlying condition, such as back pain, fibromyalgia. On top of
      this, the narcotics can reduce the effectiveness of prokinetics agents used to treat
      gastroparesis, such as metoclopramide and domperidone. At this time, there is no good
      treatment for gastroparesis, especially for opioid-related gastroparesis.

      Data suggests a relationship between opioid use and decreased gastric motility. Literature
      suggests that peripherally acting opioid agonist may provide relief in the instance of GI
      dysfunction (Holzer 2007). Movantik (Naloxegol) is an opioid agonist specifically designed to
      work outside of the central nervous system. Movantik (Naloxegol) can alleviate the adverse
      effects associated in chronic pain patients on opioid treatment - reduction of the undesired
      peripheral effects of opioids without disrupting analgesic effects. The use of Movantik
      (Naloxegol) has the potential to improve gastric dysmotility while preserving pain relief of
      the opioid analgesic.

      The objective of this study is to evaluate the effects of naloxegol in opioid-related
      gastroparesis. This will be a randomized, double-blind study comparing Movantik 25 mg to
      placebo. The dose of Movantik is the dose that is currently FDA approved for opioid-induced
      constipation. The four-week study period is the duration of the phase 2b studies for Movantik
      for opioid-induced constipation in which the response rates were 60% and 35% with active
      treatment and placebo (Chey 2015).

      The investigators have included a unique aspect of this study to better balance the benefits
      for patients participating in this randomized double-blind study in which half the patients
      receive a placebo agent. All patients in the treatment group and the placebo group will be
      invited to participate in the 4-week open-label extension for this study. This also serves to
      study the duration of the potential favorable effects of Movantik (Naloxegol) in this patient
      population as well as offering an extended time period to assess safety and tolerability.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The investigators have included a unique aspect of this study to better balance the benefits for patients participating in this randomized double-blind study in which half the patients receive a placebo agent. All patients in the treatment group and the placebo group will be invited to participate in the 4-week open-label extension for this study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Gastric Emptying (GE t-1/2)
time frame: 4 week
description: Improvement in gastric emptying (GE t-1/2) compared to Placebo
measure: Daily Symptom Improvement using the GCSI-DD (Gastroparesis Cardinal Symptom Index-Daily Diary)
time frame: 4 weeks
description: Improvements of gastroparesis symptoms using the GCSI-DD (Gastroparesis Cardinal Symptom Index-Daily Diary)
measure: Symptom Improvement using PAGI-SYM
time frame: 4 weeks
description: Improvements of gastroparesis symptoms using PAGI-SYM
measure: Pain Management using the McGill Pain Inventory
time frame: 4 weeks
description: Changes in pain control using the McGill Pain Inventory
measure: Overall improvement in Gastric Emptying (GE t-1/2)
time frame: 8 week
description: Improvement in gastric emptying (GE t-1/2) compared to Placebo
measure: Quality of Life based on SF-36
time frame: 4 weeks
description: QOL score changes based on SF-36
arm group label: Study Group
arm group type: Experimental
description: Naloxegol 25 mg, oral tablet, daily for 4 weeks
arm group label: Placebo Control
arm group type: Placebo Comparator
description: Placebo Oral Tablet, 25 mg, oral tablet, daily for 4 weeks
intervention type: Drug
intervention name: Naloxegol 25 MG Oral Tablet [Movantik]
description: Patients will be given the study drug (Movantik 25 mg).They will take this daily in the morning 1 hour before breakfast for four weeks.
arm group label: Study Group
other name: Study
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Patients will be given Placebo (Placebo 25 mg).They will take this daily in the morning 1 hour before breakfast for four weeks.
arm group label: Placebo Control
other name: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 84 Years
healthy volunteers: No
last name: Henry Parkman, MD
role: Principal Investigator
affiliation: Temple University Hospita
facility: 
country: United States
citation: Parkman HP, Hasler WL, Fisher RS; American Gastroenterological Association. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology. 2004 Nov;127(5):1592-622. doi: 10.1053/j.gastro.2004.09.055.
PMID: 15521026
citation: Abell TL, Bernstein RK, Cutts T, Farrugia G, Forster J, Hasler WL, McCallum RW, Olden KW, Parkman HP, Parrish CR, Pasricha PJ, Prather CM, Soffer EE, Twillman R, Vinik AI. Treatment of gastroparesis: a multidisciplinary clinical review. Neurogastroenterol Motil. 2006 Apr;18(4):263-83. doi: 10.1111/j.1365-2982.2006.00760.x.
PMID: 16553582
citation: Parkman HP, Yates K, Hasler WL, Nguyen L, Pasricha PJ, Snape WJ, Farrugia G, Koch KL, Calles J, Abell TL, McCallum RW, Lee L, Unalp-Arida A, Tonascia J, Hamilton F; National Institute of Diabetes and Digestive and Kidney Diseases Gastroparesis Clinical Research Consortium. Similarities and differences between diabetic and idiopathic gastroparesis. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1056-64; quiz e133-4. doi: 10.1016/j.cgh.2011.08.013. Epub 2011 Aug 24.
PMID: 21871247
citation: Anantharamu T, Sharma S, Gupta AK, Dahiya N, Singh Brashier DB, Sharma AK. Naloxegol: First oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. J Pharmacol Pharmacother. 2015 Jul-Sep;6(3):188-92. doi: 10.4103/0976-500X.162015.
PMID: 26312011
citation: Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.
PMID: 24896818
citation: Revicki DA, Rentz AM, Dubois D, Kahrilas P, Stanghellini V, Talley NJ, Tack J. Development and validation of a patient-assessed gastroparesis symptom severity measure: the Gastroparesis Cardinal Symptom Index. Aliment Pharmacol Ther. 2003 Jul 1;18(1):141-50. doi: 10.1046/j.1365-2036.2003.01612.x.
PMID: 12848636
citation: Revicki DA, Rentz AM, Tack J, Stanghellini V, Talley NJ, Kahrilas P, De La Loge C, Trudeau E, Dubois D. Responsiveness and interpretation of a symptom severity index specific to upper gastrointestinal disorders. Clin Gastroenterol Hepatol. 2004 Sep;2(9):769-77. doi: 10.1016/s1542-3565(04)00348-9.
PMID: 15354277
citation: Revicki DA, Camilleri M, Kuo B, Norton NJ, Murray L, Palsgrove A, Parkman HP. Development and content validity of a gastroparesis cardinal symptom index daily diary. Aliment Pharmacol Ther. 2009 Sep 15;30(6):670-80. doi: 10.1111/j.1365-2036.2009.04078.x. Epub 2009 Jun 25.
PMID: 19558608
citation: Abell TL, Camilleri M, Donohoe K, Hasler WL, Lin HC, Maurer AH, McCallum RW, Nowak T, Nusynowitz ML, Parkman HP, Shreve P, Szarka LA, Snape WJ Jr, Ziessman HA; American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. J Nucl Med Technol. 2008 Mar;36(1):44-54. doi: 10.2967/jnmt.107.048116. Epub 2008 Feb 20.
PMID: 18287197
citation: Maranki JL, Lytes V, Meilahn JE, Harbison S, Friedenberg FK, Fisher RS, Parkman HP. Predictive factors for clinical improvement with Enterra gastric electric stimulation treatment for refractory gastroparesis. Dig Dis Sci. 2008 Aug;53(8):2072-8. doi: 10.1007/s10620-007-0124-7. Epub 2007 Dec 14.
PMID: 18080765
citation: Szarka LA, Camilleri M, Vella A, Burton D, Baxter K, Simonson J, Zinsmeister AR. A stable isotope breath test with a standard meal for abnormal gastric emptying of solids in the clinic and in research. Clin Gastroenterol Hepatol. 2008 Jun;6(6):635-643.e1. doi: 10.1016/j.cgh.2008.01.009. Epub 2008 Apr 14.
PMID: 18406670
citation: Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.
PMID: 1235985
citation: Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
PMID: 3670870
citation: Culpepper-Morgan JA, Inturrisi CE, Portenoy RK, Foley K, Houde RW, Marsh F, Kreek MJ. Treatment of opioid-induced constipation with oral naloxone: a pilot study. Clin Pharmacol Ther. 1992 Jul;52(1):90-5. doi: 10.1038/clpt.1992.106.
PMID: 1623695
citation: Wesson DR, Ling W. The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive Drugs. 2003 Apr-Jun;35(2):253-9. doi: 10.1080/02791072.2003.10400007.
PMID: 12924748
citation: Peachey JE, Lei H. Assessment of opioid dependence with naloxone. Br J Addict. 1988 Feb;83(2):193-201. doi: 10.1111/j.1360-0443.1988.tb03981.x. No abstract available.
PMID: 3345396
citation: Tompkins DA, Bigelow GE, Harrison JA, Johnson RE, Fudala PJ, Strain EC. Concurrent validation of the Clinical Opiate Withdrawal Scale (COWS) and single-item indices against the Clinical Institute Narcotic Assessment (CINA) opioid withdrawal instrument. Drug Alcohol Depend. 2009 Nov 1;105(1-2):154-9. doi: 10.1016/j.drugalcdep.2009.07.001. Epub 2009 Aug 3.
PMID: 19647958
citation: Gandek B, Sinclair SJ, Kosinski M, Ware JE Jr. Psychometric evaluation of the SF-36 health survey in Medicare managed care. Health Care Financ Rev. 2004 Summer;25(4):5-25.
PMID: 15493441
responsible party type: Sponsor
mesh term: Gastroparesis
mesh term: Naloxegol
sharing ipd: No