Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

• Sponsor: Tanta University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02642874
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 44
• Patients Per Site Per Month: 4.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis	Drug: Methocarbamol; Drug: Calcium Carbonate	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients
• Actual Study Start Date: Apr 1, 2017
• Anticipated Primary Completion Date: Dec 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methocarbamol Methocarbamol twice daily	Drug: Methocarbamol; Methocarbamol twice daily; Other Names: Flexpro
Placebo Comparator: placebo Calcium carbonate twice daily	Drug: Calcium Carbonate; Calcium carbonate twice daily; Other Names: Calcitron

Outcome Measures

Primary Outcome Measures

1. number of muscle cramps [3 months]

   change in number of muscle cramps

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Cirrhotic patients with frequent muscle cramps.

Exclusion Criteria:

• Elderly patients.

• Encephalopathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta university - faculty of medicine	Tanta	Elgharbia	Egypt

Sponsors and Collaborators

• Tanta University

Investigators

• Principal Investigator: Sherief M. Abd-Elsalam, Consultant, liver diseases dept.- Tanta university hospital
• Study Director: Walaa A. Elkhalawany, Consultant, liver diseases dept.- Tanta university hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sherief Abd-Elsalam, Consultant liver and GIT diseases- Tanta university hospital, Tanta University
• ClinicalTrials.gov Identifier: NCT02642874
• Other Study ID Numbers: methocarbamol
• First Posted: Dec 30, 2015
• Last Update Posted: Jul 24, 2018
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Muscle Cramp; Liver Cirrhosis; Spasm; Methocarbamol; Calcium Carbonate; Calcium

Study Results

No Results Posted as of Jul 24, 2018