Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221570
Recruitment Status : Unknown
Verified October 2014 by Ibrahim Shebl, Tanta University.
Recruitment status was:  Recruiting
First Posted : August 20, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
Ibrahim Shebl, Tanta University

Tracking Information
First Submitted Date  ICMJE August 14, 2014
First Posted Date  ICMJE August 20, 2014
Last Update Posted Date October 6, 2014
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
Percentage of participants with decreased incidence of muscle cramps after taking Baclofen compared with placebo. [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02221570 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis
Official Title  ICMJE A Randomized Placebo Controlled Study of Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Muscle Cramps
  • Liver Cirrhosis
Intervention  ICMJE Drug: Baclofen
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.
Other Names:
  • Gablofen
  • Lioresal
  • Apo-Baclofen
  • Dom-Baclofen
  • Liotec
  • Med-Baclofen
  • Mylan-Baclofen
  • Novo-Baclofen
  • Nu-Baclo
  • PHL-Baclofen
  • PMS-Baclofen
  • ratio-Baclofen
  • Riva-Baclofen
Study Arms  ICMJE
  • Active Comparator: Baclofen
    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.
    Intervention: Drug: Baclofen
  • Placebo Comparator: Placebo
    placebo of baclofen
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 18, 2014)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2014
Estimated Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Cirrhosis
  • Muscle cramps( ≥3 cramps per week )

Exclusion Criteria:

  • Allergy to baclofen
  • Renal impairment
  • Pregnant and lactating women
  • Peripheral vascular disease
  • Peripheral neuropathy
  • Medications as calcium channel blockers, conjugated estrogens and naproxen.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02221570
Other Study ID Numbers  ICMJE baclofen cramps
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ibrahim Shebl, Tanta University
Study Sponsor  ICMJE Tanta University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Asem A Elfert, MD Tanta Faculty of Medicine, Professor
Study Director: Lobna A AboAli Tanta Faculty of Medicine, Lecturer
Study Director: Samah M Soliman Tanta Faculty of Medicine, Lecturer
Study Director: Ibrahim Shebl Tanta University Hospitals, House Officer
PRS Account Tanta University
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP