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Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis

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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

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.


Condition or disease Intervention/treatment Phase
Muscle Cramps Liver Cirrhosis Drug: Baclofen Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Placebo Controlled Study of Baclofen in the Treatment of Muscle Cramps in Patients With Cirrhosis
Study Start Date : June 2014
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Baclofen

Arm Intervention/treatment
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.
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

Placebo Comparator: Placebo
placebo of baclofen



Primary Outcome Measures :
  1. Percentage of participants with decreased incidence of muscle cramps after taking Baclofen compared with placebo. [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221570


Contacts
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Contact: Asem A Elfert, MD +20-122-437-8188 asem1967@yahoo.com

Locations
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Egypt
Tanta University Hospital Recruiting
Tanta, Gharbia, Egypt
Contact: Asem A Elfert, MD    +20-122-437-8188    asem1967@yahoo.com   
Principal Investigator: Asem A Elfert, MD         
Sponsors and Collaborators
Tanta University
Investigators
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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

Publications:
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Responsible Party: Ibrahim Shebl, Dr., Tanta University
ClinicalTrials.gov Identifier: NCT02221570     History of Changes
Other Study ID Numbers: baclofen cramps
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: October 6, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Muscle Cramp
Spasm
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
gamma-Aminobutyric Acid
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs