<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/NCT03282084</url>
  </required_header>
  <id_info>
    <org_study_id>D17109</org_study_id>
    <nct_id>NCT03282084</nct_id>
  </id_info>
  <brief_title>A Prospective, Observational Study of the PPI Non-responder</brief_title>
  <official_title>A Prospective, Observational Study of the PPI Non-responder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gastroesophageal reflux disease (GERD) is a common chronic condition, affecting approximately&#xD;
      20% of the American adult population. Proton pump inhibitors (PPIs) are now the mainstay of&#xD;
      medical therapy for symptoms of GERD. Despite their efficacy, several studies have shown that&#xD;
      a significant proportion of GERD patients are either partial or non-responders to PPI&#xD;
      therapy, defined as symptoms of heartburn and/or regurgitation not relieved by either a&#xD;
      standard or double dose of a PPI during a minimum trial of 8 weeks. If GERD symptoms persist,&#xD;
      further testing is required. This study will mirror the real world setting to assess the&#xD;
      value of published guidelines which recommend specific testing and treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastroesophageal reflux disease (GERD) is a common chronic condition, affecting approximately&#xD;
      20% of the American adult population. Gastroesophageal reflux disease is characterized by a&#xD;
      number of symptoms, the 2 most common being frequent heartburn and acid regurgitation.&#xD;
      Untreated or undertreated gastroesophageal reflux (GER) can lead to complications including&#xD;
      esophageal erosions, strictures, esophageal adenocarcinoma, and impaired quality of life.&#xD;
&#xD;
      Proton pump inhibitors (PPIs) are now the mainstay of medical therapy for symptoms of GERD.&#xD;
      Despite their efficacy, several studies have shown that a significant proportion of GERD&#xD;
      patients are either partial or non-responders to PPI therapy, defined as symptoms of&#xD;
      heartburn and/or regurgitation not relieved by either a standard or double dose of a PPI&#xD;
      during a minimum trial of 8 weeks. A review of 19 studies looking at GERD patients treated&#xD;
      with PPIs found an overall prevalence of partial and non-responders of up to 45% in&#xD;
      observational studies. Non-randomized studies revealed a prevalence of 17% when defined as&#xD;
      &quot;persisting troublesome heartburn&quot; and 28% when defined as troublesome regurgitation, while&#xD;
      randomized studies revealed prevalence rates of 32% and 28%, respectively.&#xD;
&#xD;
      Current guidelines recommend an 8-week trial of a daily PPI for the treatment of symptoms&#xD;
      thought secondary to GERD. However, if GERD symptoms persist despite taking the PPI&#xD;
      correctly, then testing is required. National guidelines recommend that patients with GERD&#xD;
      symptoms who have failed empiric therapy with a PPI undergo upper endoscopy (EGD). This&#xD;
      recommendation is based on data showing that the PPI non-responsive patient may have a&#xD;
      disorder (e.g., peptic ulcer disease, dyspepsia, eosinophilic esophagitis, cancer) that can&#xD;
      only be identified by EGD. During upper endoscopy a 48-hour wireless pH capsule can be placed&#xD;
      to measure acid reflux into the distal esophagus. This recommended practice has been shown to&#xD;
      be cost effective. If the 48 hour wireless pH capsule study documents pathologic acid reflux,&#xD;
      then the diagnosis of acid reflux is confirmed and the patient should be restarted on a PPI&#xD;
      with appropriate counseling regarding how to take a PPI properly. Switching the patient to an&#xD;
      alternative PPI is a reasonable strategy, as some patients respond better to one PPI than&#xD;
      another . In addition, during this index endoscopy, biopsies of the esophagus should be taken&#xD;
      to rule out eosinophilic esophagitis.&#xD;
&#xD;
      Some patients in clinical practice have previously undergone testing due to their GERD&#xD;
      symptoms. In patients with proven GERD (e.g., prior EGD with LA Grade B-D esophagitis, known&#xD;
      Barrett's esophagus, prior positive pH tests either on or off PPI therapy) who continue to&#xD;
      have GERD symptoms on a daily PPI, guidelines recommend that impedance pH-testing be&#xD;
      performed on daily PPI therapy. Guidelines do not recommend testing on b.i.d. PPI therapy,&#xD;
      since most patients with GERD do not require twice-daily PPI therapy. In this patient&#xD;
      population (the PPI non-responder with proven GERD), impedance-pH testing is preferable to&#xD;
      48-hour wireless pH capsule testing as non-acid reflux can be detected as well. To be cost&#xD;
      effective, and to reduce the number of unnecessary EGDs, if upper endoscopy was recently&#xD;
      performed, then impedance-pH testing can be performed after accurate localization of the&#xD;
      lower esophageal sphincter using high resolution esophageal manometry (HREM). If the&#xD;
      impedance-pH test is negative (normal) on daily PPI therapy, demonstrating that acid reflux&#xD;
      is controlled, then a second diagnosis should to be considered (e.g., functional dyspepsia,&#xD;
      gastroparesis, an esophageal motility disorder). If impedance-pH monitoring demonstrates&#xD;
      abnormal acid reflux on daily PPI therapy, then guidelines recommend that the PPI dose should&#xD;
      be increased to twice daily and symptoms reassessed at 8 weeks.&#xD;
&#xD;
      The clinical treatment pathways outlined above are based on national guidelines and are&#xD;
      promoted as standards of care. However, despite the fact that these guidelines recommend&#xD;
      distinct diagnostic pathways for patients who are non-responsive to PPIs, there is little&#xD;
      &quot;real-world&quot; data to support these guidelines and no information about the outcomes of these&#xD;
      patients who are treated using these diagnostic pathways. The simple goal of this study is to&#xD;
      identify the PPI non-responder patient with GERD symptoms and identify and quantify the type,&#xD;
      number and outcomes of diagnostic tests recommended by national guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    insufficient funding&#xD;
  </why_stopped>
  <start_date type="Actual">June 20, 2017</start_date>
  <completion_date type="Actual">June 15, 2018</completion_date>
  <primary_completion_date type="Actual">June 15, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Objectively evaluate PPI non-responder</measure>
    <time_frame>8 Weeks after visit 2</time_frame>
    <description>Number of participants with unproven GERD who have reflux esophagitis and eosinophile esophagitis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Esophageal acid exposure</measure>
    <time_frame>8 Weeks after visit 2</time_frame>
    <description>Number and extent of abnormal acid exposure as measured by pH-metry (Bravo capsule) off PPI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response to different PPI</measure>
    <time_frame>8 Weeks after visit 2</time_frame>
    <description>Percentage of patients with GERD who fail standard PPI Therapy as documented by wireless pH capsule testing that then respond to an alternative PPI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Document the amount of esophageal acid and non-acid exposure in the PPI non-responder patient with proven GERD</measure>
    <time_frame>8 Weeks after visit 2</time_frame>
    <description>Amount of acid and non-acid exposure in PPI-nonresponder patients with proven GERD as measured by impedance-pH testing on daily PPI therapy.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine the type, frequency and extent of esophageal motility disorders</measure>
    <time_frame>8 Weeks after visit 2</time_frame>
    <description>Determine the type, frequency and extent of esophageal motility disorders using HREM (high resolution esophageal manometry) in patients with persistent GERD symptoms despite PPI therapy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nepean Dyspepsia Index</measure>
    <time_frame>8 Weeks after visit 2</time_frame>
    <description>Using a validated questionnaire determine the prevalence and severity of functional dyspepsia in patients presenting with GERD symptoms using the Nepean Dyspepsia Index.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlate subjective symptoms of GERD with objective evidence of acid reflux</measure>
    <time_frame>8 Weeks after visit 2</time_frame>
    <description>Comparison of symptomatic GERD based on GERD-Q validated questionnaire and pH testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess overlapping symptoms of dysphagia and GERD</measure>
    <time_frame>8 Weeks after visit 2</time_frame>
    <description>Assess overlapping symptoms of dysphagia in patients with GERD symptoms who do not respond to empiric PPI therapy using a validated dysphagia questionnaire.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Gastro Esophageal Reflux Disease PPI Non-Responders</condition>
  <arm_group>
    <arm_group_label>Unproven GERD</arm_group_label>
    <description>Subjects with no prior testing, normal prior EGD or prior LA Grade A esophagitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Proven GERD</arm_group_label>
    <description>LA Grade B-D esophagitis, long-segment Barrett's, prior positive pH study</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>EGD with biopsy</intervention_name>
    <description>Stop PPI and schedule for EGD with biopsy and Wireless pH capsule testing for 7-10 days later. Consider gastric emptying scan or high resolution esophageal manometry</description>
    <arm_group_label>Unproven GERD</arm_group_label>
    <other_name>Wireless pH Capsule</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>EGD and impedance-pH study on PPI</intervention_name>
    <description>Continue PPI and schedule EGD and Impedance-pH study on PPI. Consider gastric emptying scan or high resolution esophageal manometry</description>
    <arm_group_label>Proven GERD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with persistent GERD symptoms despite treatment with a minimum of 8 weeks daily&#xD;
        PPI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to sign informed consent&#xD;
&#xD;
          -  Persistent GERD symptoms after minimum 8 week trial on daily PPI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling to sign informed consent&#xD;
&#xD;
          -  Prior anti-reflux surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brian E Lacy, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <reference>
    <citation>Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.</citation>
    <PMID>9136821</PMID>
  </reference>
  <reference>
    <citation>Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6. doi: 10.1007/BF01071906.</citation>
    <PMID>984016</PMID>
  </reference>
  <reference>
    <citation>El-Serag H, Becher A, Jones R. Systematic review: persistent reflux symptoms on proton pump inhibitor therapy in primary care and community studies. Aliment Pharmacol Ther. 2010 Sep;32(6):720-37. doi: 10.1111/j.1365-2036.2010.04406.x.</citation>
    <PMID>20662774</PMID>
  </reference>
  <reference>
    <citation>Richter JE. How to manage refractory GERD. Nat Clin Pract Gastroenterol Hepatol. 2007 Dec;4(12):658-64. doi: 10.1038/ncpgasthep0979.</citation>
    <PMID>18043675</PMID>
  </reference>
  <reference>
    <citation>Cicala M, Emerenziani S, Guarino MP, Ribolsi M. Proton pump inhibitor resistance, the real challenge in gastro-esophageal reflux disease. World J Gastroenterol. 2013 Oct 21;19(39):6529-35. doi: 10.3748/wjg.v19.i39.6529.</citation>
    <PMID>24151377</PMID>
  </reference>
  <reference>
    <citation>Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available. Erratum In: Am J Gastroenterol. 2013 Oct;108(10):1672.</citation>
    <PMID>23419381</PMID>
  </reference>
  <reference>
    <citation>Dickman R, Boaz M, Aizic S, Beniashvili Z, Fass R, Niv Y. Comparison of clinical characteristics of patients with gastroesophageal reflux disease who failed proton pump inhibitor therapy versus those who fully responded. J Neurogastroenterol Motil. 2011 Oct;17(4):387-94. doi: 10.5056/jnm.2011.17.4.387. Epub 2011 Oct 31.</citation>
    <PMID>22148108</PMID>
  </reference>
  <reference>
    <citation>Lee WC, Yeh YC, Lacy BE, Pandolfino JE, Brill JV, Weinstein ML, Carlson AM, Williams MJ, Wittek MR, Pashos CL. Timely confirmation of gastro-esophageal reflux disease via pH monitoring: estimating budget impact on managed care organizations. Curr Med Res Opin. 2008 May;24(5):1317-27. doi: 10.1185/030079908x280680. Epub 2008 Mar 27.</citation>
    <PMID>18377705</PMID>
  </reference>
  <reference>
    <citation>Miller SM, Goldstein JL, Gerson LB. Cost-effectiveness model of endoscopic biopsy for eosinophilic esophagitis in patients with refractory GERD. Am J Gastroenterol. 2011 Aug;106(8):1439-45. doi: 10.1038/ajg.2011.94. Epub 2011 Mar 29.</citation>
    <PMID>21448144</PMID>
  </reference>
  <reference>
    <citation>Charbel S, Khandwala F, Vaezi MF. The role of esophageal pH monitoring in symptomatic patients on PPI therapy. Am J Gastroenterol. 2005 Feb;100(2):283-9. doi: 10.1111/j.1572-0241.2005.41210.x.</citation>
    <PMID>15667483</PMID>
  </reference>
  <reference>
    <citation>Mainie I, Tutuian R, Shay S, Vela M, Zhang X, Sifrim D, Castell DO. Acid and non-acid reflux in patients with persistent symptoms despite acid suppressive therapy: a multicentre study using combined ambulatory impedance-pH monitoring. Gut. 2006 Oct;55(10):1398-402. doi: 10.1136/gut.2005.087668. Epub 2006 Mar 23.</citation>
    <PMID>16556669</PMID>
  </reference>
  <reference>
    <citation>Quigley EM, Lacy BE. Overlap of functional dyspepsia and GERD--diagnostic and treatment implications. Nat Rev Gastroenterol Hepatol. 2013 Mar;10(3):175-86. doi: 10.1038/nrgastro.2012.253. Epub 2013 Jan 8.</citation>
    <PMID>23296247</PMID>
  </reference>
  <reference>
    <citation>Camilleri M, Parkman HP, Shafi MA, Abell TL, Gerson L; American College of Gastroenterology. Clinical guideline: management of gastroparesis. Am J Gastroenterol. 2013 Jan;108(1):18-37; quiz 38. doi: 10.1038/ajg.2012.373. Epub 2012 Nov 13.</citation>
    <PMID>23147521</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>June 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>March 29, 2019</last_update_submitted>
  <last_update_submitted_qc>March 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
  </condition_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/NCT03282084
org study id: D17109
nct id: NCT03282084
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Gastroesophageal reflux disease (GERD) is a common chronic condition, affecting approximately
      20% of the American adult population. Proton pump inhibitors (PPIs) are now the mainstay of
      medical therapy for symptoms of GERD. Despite their efficacy, several studies have shown that
      a significant proportion of GERD patients are either partial or non-responders to PPI
      therapy, defined as symptoms of heartburn and/or regurgitation not relieved by either a
      standard or double dose of a PPI during a minimum trial of 8 weeks. If GERD symptoms persist,
      further testing is required. This study will mirror the real world setting to assess the
      value of published guidelines which recommend specific testing and treatment.
Gastroesophageal reflux disease (GERD) is a common chronic condition, affecting approximately
      20% of the American adult population. Gastroesophageal reflux disease is characterized by a
      number of symptoms, the 2 most common being frequent heartburn and acid regurgitation.
      Untreated or undertreated gastroesophageal reflux (GER) can lead to complications including
      esophageal erosions, strictures, esophageal adenocarcinoma, and impaired quality of life.

      Proton pump inhibitors (PPIs) are now the mainstay of medical therapy for symptoms of GERD.
      Despite their efficacy, several studies have shown that a significant proportion of GERD
      patients are either partial or non-responders to PPI therapy, defined as symptoms of
      heartburn and/or regurgitation not relieved by either a standard or double dose of a PPI
      during a minimum trial of 8 weeks. A review of 19 studies looking at GERD patients treated
      with PPIs found an overall prevalence of partial and non-responders of up to 45% in
      observational studies. Non-randomized studies revealed a prevalence of 17% when defined as
      "persisting troublesome heartburn" and 28% when defined as troublesome regurgitation, while
      randomized studies revealed prevalence rates of 32% and 28%, respectively.

      Current guidelines recommend an 8-week trial of a daily PPI for the treatment of symptoms
      thought secondary to GERD. However, if GERD symptoms persist despite taking the PPI
      correctly, then testing is required. National guidelines recommend that patients with GERD
      symptoms who have failed empiric therapy with a PPI undergo upper endoscopy (EGD). This
      recommendation is based on data showing that the PPI non-responsive patient may have a
      disorder (e.g., peptic ulcer disease, dyspepsia, eosinophilic esophagitis, cancer) that can
      only be identified by EGD. During upper endoscopy a 48-hour wireless pH capsule can be placed
      to measure acid reflux into the distal esophagus. This recommended practice has been shown to
      be cost effective. If the 48 hour wireless pH capsule study documents pathologic acid reflux,
      then the diagnosis of acid reflux is confirmed and the patient should be restarted on a PPI
      with appropriate counseling regarding how to take a PPI properly. Switching the patient to an
      alternative PPI is a reasonable strategy, as some patients respond better to one PPI than
      another . In addition, during this index endoscopy, biopsies of the esophagus should be taken
      to rule out eosinophilic esophagitis.

      Some patients in clinical practice have previously undergone testing due to their GERD
      symptoms. In patients with proven GERD (e.g., prior EGD with LA Grade B-D esophagitis, known
      Barrett's esophagus, prior positive pH tests either on or off PPI therapy) who continue to
      have GERD symptoms on a daily PPI, guidelines recommend that impedance pH-testing be
      performed on daily PPI therapy. Guidelines do not recommend testing on b.i.d. PPI therapy,
      since most patients with GERD do not require twice-daily PPI therapy. In this patient
      population (the PPI non-responder with proven GERD), impedance-pH testing is preferable to
      48-hour wireless pH capsule testing as non-acid reflux can be detected as well. To be cost
      effective, and to reduce the number of unnecessary EGDs, if upper endoscopy was recently
      performed, then impedance-pH testing can be performed after accurate localization of the
      lower esophageal sphincter using high resolution esophageal manometry (HREM). If the
      impedance-pH test is negative (normal) on daily PPI therapy, demonstrating that acid reflux
      is controlled, then a second diagnosis should to be considered (e.g., functional dyspepsia,
      gastroparesis, an esophageal motility disorder). If impedance-pH monitoring demonstrates
      abnormal acid reflux on daily PPI therapy, then guidelines recommend that the PPI dose should
      be increased to twice daily and symptoms reassessed at 8 weeks.

      The clinical treatment pathways outlined above are based on national guidelines and are
      promoted as standards of care. However, despite the fact that these guidelines recommend
      distinct diagnostic pathways for patients who are non-responsive to PPIs, there is little
      "real-world" data to support these guidelines and no information about the outcomes of these
      patients who are treated using these diagnostic pathways. The simple goal of this study is to
      identify the PPI non-responder patient with GERD symptoms and identify and quantify the type,
      number and outcomes of diagnostic tests recommended by national guidelines.
observational model: Other
time perspective: Prospective
measure: Objectively evaluate PPI non-responder
time frame: 8 Weeks after visit 2
description: Number of participants with unproven GERD who have reflux esophagitis and eosinophile esophagitis
measure: Esophageal acid exposure
time frame: 8 Weeks after visit 2
description: Number and extent of abnormal acid exposure as measured by pH-metry (Bravo capsule) off PPI.
measure: Response to different PPI
time frame: 8 Weeks after visit 2
description: Percentage of patients with GERD who fail standard PPI Therapy as documented by wireless pH capsule testing that then respond to an alternative PPI
measure: Document the amount of esophageal acid and non-acid exposure in the PPI non-responder patient with proven GERD
time frame: 8 Weeks after visit 2
description: Amount of acid and non-acid exposure in PPI-nonresponder patients with proven GERD as measured by impedance-pH testing on daily PPI therapy.
measure: Determine the type, frequency and extent of esophageal motility disorders
time frame: 8 Weeks after visit 2
description: Determine the type, frequency and extent of esophageal motility disorders using HREM (high resolution esophageal manometry) in patients with persistent GERD symptoms despite PPI therapy
measure: Nepean Dyspepsia Index
time frame: 8 Weeks after visit 2
description: Using a validated questionnaire determine the prevalence and severity of functional dyspepsia in patients presenting with GERD symptoms using the Nepean Dyspepsia Index.
measure: Correlate subjective symptoms of GERD with objective evidence of acid reflux
time frame: 8 Weeks after visit 2
description: Comparison of symptomatic GERD based on GERD-Q validated questionnaire and pH testing
measure: Assess overlapping symptoms of dysphagia and GERD
time frame: 8 Weeks after visit 2
description: Assess overlapping symptoms of dysphagia in patients with GERD symptoms who do not respond to empiric PPI therapy using a validated dysphagia questionnaire.
arm group label: Unproven GERD
description: Subjects with no prior testing, normal prior EGD or prior LA Grade A esophagitis
arm group label: Proven GERD
description: LA Grade B-D esophagitis, long-segment Barrett's, prior positive pH study
intervention type: Diagnostic Test
intervention name: EGD with biopsy
description: Stop PPI and schedule for EGD with biopsy and Wireless pH capsule testing for 7-10 days later. Consider gastric emptying scan or high resolution esophageal manometry
arm group label: Unproven GERD
other name: Wireless pH Capsule
intervention type: Diagnostic Test
intervention name: EGD and impedance-pH study on PPI
description: Continue PPI and schedule EGD and Impedance-pH study on PPI. Consider gastric emptying scan or high resolution esophageal manometry
arm group label: Proven GERD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brian E Lacy, MD, PhD
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
country: United States
citation: Locke GR 3rd, Talley NJ, Fett SL, Zinsmeister AR, Melton LJ 3rd. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterology. 1997 May;112(5):1448-56. doi: 10.1016/s0016-5085(97)70025-8.
PMID: 9136821
citation: Nebel OT, Fornes MF, Castell DO. Symptomatic gastroesophageal reflux: incidence and precipitating factors. Am J Dig Dis. 1976 Nov;21(11):953-6. doi: 10.1007/BF01071906.
PMID: 984016
citation: El-Serag H, Becher A, Jones R. Systematic review: persistent reflux symptoms on proton pump inhibitor therapy in primary care and community studies. Aliment Pharmacol Ther. 2010 Sep;32(6):720-37. doi: 10.1111/j.1365-2036.2010.04406.x.
PMID: 20662774
citation: Richter JE. How to manage refractory GERD. Nat Clin Pract Gastroenterol Hepatol. 2007 Dec;4(12):658-64. doi: 10.1038/ncpgasthep0979.
PMID: 18043675
citation: Cicala M, Emerenziani S, Guarino MP, Ribolsi M. Proton pump inhibitor resistance, the real challenge in gastro-esophageal reflux disease. World J Gastroenterol. 2013 Oct 21;19(39):6529-35. doi: 10.3748/wjg.v19.i39.6529.
PMID: 24151377
citation: Katz PO, Gerson LB, Vela MF. Guidelines for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2013 Mar;108(3):308-28; quiz 329. doi: 10.1038/ajg.2012.444. Epub 2013 Feb 19. No abstract available. Erratum In: Am J Gastroenterol. 2013 Oct;108(10):1672.
PMID: 23419381
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responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
sharing ipd: No