Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

Tanta University

Status and phase: Unknown; Phase 3

Conditions: Liver Cirrhosis

Treatments: Drug: Calcium Carbonate; Drug: Methocarbamol

Study type: Interventional

Funder types: Other

Identifiers

NCT02642874

methocarbamol

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cirrhotic patients with frequent muscle cramps.

Exclusion criteria

• Elderly patients.
• Encephalopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups, including a placebo group

Methocarbamol

Experimental group

Description:

Methocarbamol twice daily

Treatment:

Drug: Methocarbamol

placebo

Placebo Comparator group

Description:

Calcium carbonate twice daily

Treatment:

Drug: Calcium Carbonate