NCT02642874

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2017

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

3.7 years

First QC Date

December 25, 2015

Last Update Submit

July 21, 2018

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • number of muscle cramps

    change in number of muscle cramps

    3 months

Study Arms (2)

Methocarbamol

EXPERIMENTAL

Methocarbamol twice daily

Drug: Methocarbamol

placebo

PLACEBO COMPARATOR

Calcium carbonate twice daily

Drug: Calcium Carbonate

Interventions

MethocarbamolDRUG

Methocarbamol twice daily

Also known as: Flexpro
Methocarbamol
Calcium CarbonateDRUG

Calcium carbonate twice daily

Also known as: Calcitron
placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cirrhotic patients with frequent muscle cramps.

You may not qualify if:

  • Elderly patients.
  • Encephalopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university - faculty of medicine

Tanta, Elgharbia, Egypt

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

MethocarbamolCalcium Carbonate

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsGuaifenesinGuaiacolMethyl EthersEthersPhenyl EthersPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Sherief M. Abd-Elsalam, Consultant

    liver diseases dept.- Tanta university hospital

    PRINCIPAL INVESTIGATOR

  • Walaa A. Elkhalawany, Consultant

    liver diseases dept.- Tanta university hospital

    STUDY DIRECTOR

Central Study Contacts

Sherief M. Abd-Elsalam, Consultant

CONTACT

00201095159522sherif_tropical@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant liver and GIT diseases- Tanta university hospital

Study Record Dates

First Submitted

December 25, 2015

First Posted

December 30, 2015

Study Start

April 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

July 24, 2018

Record last verified: 2018-07

Locations

EG(1)