Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

Phase 3

• Conditions: Liver Cirrhosis
• Interventions: Drug: Methocarbamol; Drug: Calcium Carbonate

• Registration Number: NCT02642874
• Lead Sponsor: Tanta University

Brief Summary

Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug. Methocarbamol is a central muscle relaxant used to treat skeletal muscle spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide range of safe and effective dosages.

Detailed Description

Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug. Abrams et al compared patients with cirrhosis with those with congestive heart failure and found a significantly higher prevalence of weekly or daily cramps with cirrhosis (22%) vs patients with congestive heart failure (5%). Interestingly, there was no difference in diuretic use or dosing between the 2 groups, supporting that factors other than diuretic-mediated effects explained the differences. Methocarbamol is a central muscle relaxant used to treat skeletal muscle spasms. The mechanism of action of methocarbamol is currently unknown, but may involve the inhibition of carbonic anhydrase. Methocarbamol has a high therapeutic index, i.e. a wide range of safe and effective dosages.

Study Timeline

• Study First Submitted: 2015-12-25
• Study First Submitted QC: 2015-12-25
• Study First Posted: 2015-12-30
• Study Start: 2017-04-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-21
• Last Update Posted: 2018-07-24
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Cirrhotic patients with frequent muscle cramps.

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Exclusion Criteria

• Elderly patients.
• Encephalopathy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methocarbamol	Methocarbamol	Methocarbamol twice daily
placebo	Calcium Carbonate	Calcium carbonate twice daily

Primary Outcome Measures

Name	Time	Method
number of muscle cramps	3 months	change in number of muscle cramps

Trial Locations

Locations (1)

Tanta university - faculty of medicine; 🇪🇬 Tanta, Elgharbia, Egypt