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Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

Primary Purpose

Liver Cirrhosis

Status

Unknown status

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Methocarbamol

Calcium Carbonate

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Cirrhotic patients with frequent muscle cramps.

Exclusion Criteria:

Elderly patients.
Encephalopathy

Sites / Locations

Tanta university - faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methocarbamol

placebo

Arm Description

Methocarbamol twice daily

Calcium carbonate twice daily

Outcomes

Primary Outcome Measures

number of muscle cramps

change in number of muscle cramps

Secondary Outcome Measures

Full Information

NCT ID

NCT02642874

First Posted

December 25, 2015

Last Updated

July 21, 2018

Sponsor

Tanta University

1. Study Identification

Unique Protocol Identification Number

NCT02642874

Brief Title

Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

Official Title

Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cirrhosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Methocarbamol

Arm Type

Experimental

Arm Description

Methocarbamol twice daily

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Calcium carbonate twice daily

Intervention Type

Drug

Intervention Name(s)

Methocarbamol

Other Intervention Name(s)

Flexpro

Intervention Description

Methocarbamol twice daily

Intervention Type

Drug

Intervention Name(s)

Calcium Carbonate

Other Intervention Name(s)

Calcitron

Intervention Description

Calcium carbonate twice daily

Primary Outcome Measure Information:

Title

number of muscle cramps

Description

change in number of muscle cramps

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cirrhotic patients with frequent muscle cramps. Exclusion Criteria: Elderly patients. Encephalopathy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sherief M. Abd-Elsalam, Consultant

Phone

00201095159522

sherif_tropical@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sherief M. Abd-Elsalam, Consultant

Organizational Affiliation

liver diseases dept.- Tanta university hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Walaa A. Elkhalawany, Consultant

Organizational Affiliation

liver diseases dept.- Tanta university hospital

Official's Role

Study Director

Facility Information:

Facility Name

Tanta university - faculty of medicine

City

Tanta

State/Province

Elgharbia

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherief Abdelsalam, lecturer

Phone

00201095159522

Sheriefabdelsalam@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Methocarbamol in Treatment of Muscle Cramps in Cirrhotic Patients

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