<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/NCT02221570</url>
  </required_header>
  <id_info>
    <org_study_id>baclofen cramps</org_study_id>
    <nct_id>NCT02221570</nct_id>
  </id_info>
  <brief_title>Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis</brief_title>
  <official_title>A Randomized Placebo Controlled Study of Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tanta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism&#xD;
      of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are&#xD;
      associated with significantly diminished quality of life.&#xD;
&#xD;
      The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps&#xD;
      in patients with liver cirrhosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Muscle cramps are common in patients with liver disease and associated with significantly&#xD;
      diminished quality of life. Patients with cirrhosis often experience muscle cramps with&#xD;
      varied frequency and severity. The exact mechanisms by which they occur remain unclear,&#xD;
      although a number of pathophysiological events unique to liver disease may contribute.&#xD;
      Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism,&#xD;
      and plasma volume/electrolytes.&#xD;
&#xD;
      Although a number of mechanisms for cramps in liver disease have been postulated and have&#xD;
      been targeted by medical therapies, a clear picture of the causal events has not emerged.&#xD;
      Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and&#xD;
      branched-chain amino acids have shown some benefit in small uncontrolled studies, although&#xD;
      large randomized controlled trials are lacking.&#xD;
&#xD;
      Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic&#xD;
      agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal&#xD;
      tract lesions. Baclofen was also tested with promising results in the treatment of other&#xD;
      medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups&#xD;
      and cough.&#xD;
&#xD;
      The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps&#xD;
      in patients with liver cirrhosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2014</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of participants with decreased incidence of muscle cramps after taking Baclofen compared with placebo.</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Muscle Cramps</condition>
  <condition>Liver Cirrhosis</condition>
  <arm_group>
    <arm_group_label>Baclofen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo of baclofen</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baclofen</intervention_name>
    <description>Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.</description>
    <arm_group_label>Baclofen</arm_group_label>
    <other_name>Gablofen</other_name>
    <other_name>Lioresal</other_name>
    <other_name>Apo-Baclofen</other_name>
    <other_name>Dom-Baclofen</other_name>
    <other_name>Liotec</other_name>
    <other_name>Med-Baclofen</other_name>
    <other_name>Mylan-Baclofen</other_name>
    <other_name>Novo-Baclofen</other_name>
    <other_name>Nu-Baclo</other_name>
    <other_name>PHL-Baclofen</other_name>
    <other_name>PMS-Baclofen</other_name>
    <other_name>ratio-Baclofen</other_name>
    <other_name>Riva-Baclofen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cirrhosis&#xD;
&#xD;
          -  Muscle cramps( ≥3 cramps per week )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to baclofen&#xD;
&#xD;
          -  Renal impairment&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Peripheral vascular disease&#xD;
&#xD;
          -  Peripheral neuropathy&#xD;
&#xD;
          -  Medications as calcium channel blockers, conjugated estrogens and naproxen.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Asem A Elfert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tanta Faculty of Medicine, Professor</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lobna A AboAli</last_name>
    <role>Study Director</role>
    <affiliation>Tanta Faculty of Medicine, Lecturer</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samah M Soliman</last_name>
    <role>Study Director</role>
    <affiliation>Tanta Faculty of Medicine, Lecturer</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ibrahim Shebl</last_name>
    <role>Study Director</role>
    <affiliation>Tanta University Hospitals, House Officer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Asem A Elfert, MD</last_name>
    <phone>+20-122-437-8188</phone>
    <email>asem1967@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tanta University Hospital</name>
      <address>
        <city>Tanta</city>
        <state>Gharbia</state>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Asem A Elfert, MD</last_name>
      <phone>+20-122-437-8188</phone>
      <email>asem1967@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Asem A Elfert, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Chatrath H, Liangpunsakul S, Ghabril M, Otte J, Chalasani N, Vuppalanchi R. Prevalence and morbidity associated with muscle cramps in patients with cirrhosis. Am J Med. 2012 Oct;125(10):1019-25. doi: 10.1016/j.amjmed.2012.03.012. Epub 2012 Jul 24.</citation>
    <PMID>22835465</PMID>
  </reference>
  <reference>
    <citation>Mehta SS, Fallon MB. Muscle cramps in liver disease. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1385-91; quiz e80. doi: 10.1016/j.cgh.2013.03.017. Epub 2013 Mar 28.</citation>
    <PMID>23542334</PMID>
  </reference>
  <reference>
    <citation>Hudgson P, Weightman D. Baclofen in the treatment of spasticity. Br Med J. 1971 Oct 2;4(5778):15-7. doi: 10.1136/bmj.4.5778.15.</citation>
    <PMID>4938243</PMID>
  </reference>
  <reference>
    <citation>Hering-Hanit R, Gadoth N. The use of baclofen in cluster headache. Curr Pain Headache Rep. 2001 Feb;5(1):79-82. doi: 10.1007/s11916-001-0014-1.</citation>
    <PMID>11252142</PMID>
  </reference>
  <reference>
    <citation>Orr WC, Goodrich S, Wright S, Shepherd K, Mellow M. The effect of baclofen on nocturnal gastroesophageal reflux and measures of sleep quality: a randomized, cross-over trial. Neurogastroenterol Motil. 2012 Jun;24(6):553-9, e253. doi: 10.1111/j.1365-2982.2012.01900.x. Epub 2012 Mar 8.</citation>
    <PMID>22404184</PMID>
  </reference>
  <reference>
    <citation>Burke AM, White AB, Brill N. Baclofen for intractable hiccups. N Engl J Med. 1988 Nov 17;319(20):1354. doi: 10.1056/NEJM198811173192016. No abstract available.</citation>
    <PMID>3185643</PMID>
  </reference>
  <reference>
    <citation>Froestl W. Chemistry and pharmacology of GABAB receptor ligands. Adv Pharmacol. 2010;58:19-62. doi: 10.1016/S1054-3589(10)58002-5.</citation>
    <PMID>20655477</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>October 2, 2014</last_update_submitted>
  <last_update_submitted_qc>October 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Ibrahim Shebl</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Cramp</mesh_term>
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Spasm</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Baclofen</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02221570
org study id: baclofen cramps
nct id: NCT02221570
lead sponsor: 
has dmc: Yes
Patients with cirrhosis often experience muscle cramps with varying severity. The mechanism
      of their occurrence is not yet understood. Muscle cramps in patients with cirrhosis are
      associated with significantly diminished quality of life.

      The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps
      in patients with liver cirrhosis.
Muscle cramps are common in patients with liver disease and associated with significantly
      diminished quality of life. Patients with cirrhosis often experience muscle cramps with
      varied frequency and severity. The exact mechanisms by which they occur remain unclear,
      although a number of pathophysiological events unique to liver disease may contribute.
      Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism,
      and plasma volume/electrolytes.

      Although a number of mechanisms for cramps in liver disease have been postulated and have
      been targeted by medical therapies, a clear picture of the causal events has not emerged.
      Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and
      branched-chain amino acids have shown some benefit in small uncontrolled studies, although
      large randomized controlled trials are lacking.

      Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic
      agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal
      tract lesions. Baclofen was also tested with promising results in the treatment of other
      medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups
      and cough.

      The aim of the study is to assess the efficacy of baclofen in the treatment of muscle cramps
      in patients with liver cirrhosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percentage of participants with decreased incidence of muscle cramps after taking Baclofen compared with placebo.
time frame: 3 months
arm group label: Baclofen
arm group type: Active Comparator
description: Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.
arm group label: Placebo
arm group type: Placebo Comparator
description: placebo of baclofen
intervention type: Drug
intervention name: Baclofen
description: Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.
arm group label: Baclofen
other name: Gablofen
other name: Lioresal
other name: Apo-Baclofen
other name: Dom-Baclofen
other name: Liotec
other name: Med-Baclofen
other name: Mylan-Baclofen
other name: Novo-Baclofen
other name: Nu-Baclo
other name: PHL-Baclofen
other name: PMS-Baclofen
other name: ratio-Baclofen
other name: Riva-Baclofen
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Asem A Elfert, MD
role: Principal Investigator
affiliation: Tanta Faculty of Medicine, Professor
last name: Lobna A AboAli
role: Study Director
affiliation: Tanta Faculty of Medicine, Lecturer
last name: Samah M Soliman
role: Study Director
affiliation: Tanta Faculty of Medicine, Lecturer
last name: Ibrahim Shebl
role: Study Director
affiliation: Tanta University Hospitals, House Officer
last name: Asem A Elfert, MD
phone: +20-122-437-8188
email: asem1967@yahoo.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Egypt
citation: Chatrath H, Liangpunsakul S, Ghabril M, Otte J, Chalasani N, Vuppalanchi R. Prevalence and morbidity associated with muscle cramps in patients with cirrhosis. Am J Med. 2012 Oct;125(10):1019-25. doi: 10.1016/j.amjmed.2012.03.012. Epub 2012 Jul 24.
PMID: 22835465
citation: Mehta SS, Fallon MB. Muscle cramps in liver disease. Clin Gastroenterol Hepatol. 2013 Nov;11(11):1385-91; quiz e80. doi: 10.1016/j.cgh.2013.03.017. Epub 2013 Mar 28.
PMID: 23542334
citation: Hudgson P, Weightman D. Baclofen in the treatment of spasticity. Br Med J. 1971 Oct 2;4(5778):15-7. doi: 10.1136/bmj.4.5778.15.
PMID: 4938243
citation: Hering-Hanit R, Gadoth N. The use of baclofen in cluster headache. Curr Pain Headache Rep. 2001 Feb;5(1):79-82. doi: 10.1007/s11916-001-0014-1.
PMID: 11252142
citation: Orr WC, Goodrich S, Wright S, Shepherd K, Mellow M. The effect of baclofen on nocturnal gastroesophageal reflux and measures of sleep quality: a randomized, cross-over trial. Neurogastroenterol Motil. 2012 Jun;24(6):553-9, e253. doi: 10.1111/j.1365-2982.2012.01900.x. Epub 2012 Mar 8.
PMID: 22404184
citation: Burke AM, White AB, Brill N. Baclofen for intractable hiccups. N Engl J Med. 1988 Nov 17;319(20):1354. doi: 10.1056/NEJM198811173192016. No abstract available.
PMID: 3185643
citation: Froestl W. Chemistry and pharmacology of GABAB receptor ligands. Adv Pharmacol. 2010;58:19-62. doi: 10.1016/S1054-3589(10)58002-5.
PMID: 20655477
responsible party type: Principal Investigator
investigator affiliation: Tanta University
investigator full name: Ibrahim Shebl
investigator title: Dr.
mesh term: Muscle Cramp
mesh term: Liver Cirrhosis
mesh term: Spasm
mesh term: Fibrosis
mesh term: Baclofen