Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

NCT ID: NCT02642874

Last Updated: 2018-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cirrhosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Methocarbamol

Methocarbamol twice daily

Group Type EXPERIMENTAL

Methocarbamol

Intervention Type DRUG

Methocarbamol twice daily

placebo

Calcium carbonate twice daily

Group Type PLACEBO_COMPARATOR

Calcium Carbonate

Intervention Type DRUG

Calcium carbonate twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methocarbamol

Methocarbamol twice daily

Intervention Type DRUG

Calcium Carbonate

Calcium carbonate twice daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Flexpro Calcitron

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cirrhotic patients with frequent muscle cramps.

Exclusion Criteria

* Elderly patients.
* Encephalopathy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tanta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sherief Abd-Elsalam

Consultant liver and GIT diseases- Tanta university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sherief M. Abd-Elsalam, Consultant

Role: PRINCIPAL_INVESTIGATOR

liver diseases dept.- Tanta university hospital

Walaa A. Elkhalawany, Consultant

Role: STUDY_DIRECTOR

liver diseases dept.- Tanta university hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tanta university - faculty of medicine

Tanta, Elgharbia, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sherief M. Abd-Elsalam, Consultant

Role: CONTACT

00201095159522

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sherief Abdelsalam, lecturer

Role: primary

00201095159522

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

methocarbamol

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Spirulina Tablets Treat Liver Fibrosis/Cirrhosis
NCT06770283 ACTIVE_NOT_RECRUITING NA
Muscles in Liver Diseases
NCT04758793 NOT_YET_RECRUITING NA