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NCT02642874 Clinical Trial

Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

Liver Cirrhosis Clinical Trial

Official title:
Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02642874
Other study ID # methocarbamol
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 1, 2017
Est. completion date December 2020

Study information
Verified date July 2018
Source Tanta University
Contact Sherief M. Abd-Elsalam, Consultant
Phone 00201095159522
Email sherif_tropical@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Cirrhotic patients with frequent muscle cramps.

Exclusion Criteria:

- Elderly patients.

- Encephalopathy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Methocarbamol
Methocarbamol twice daily
• Calcium Carbonate
Calcium carbonate twice daily

Locations
Country Name City State
Egypt Tanta university - faculty of medicine Tanta Elgharbia

Sponsors (1)
Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary number of muscle cramps change in number of muscle cramps 3 months
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