NCT02642484

Brief Summary

  • Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug.
  • Quinine was suggested for treatment of patients with muscle cramps in patients with liver cirrhosis. However, thrombocytopenia, cardiac arrhythmias and cinchonism are serious side effects.

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 Dec 2018

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 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
2.9 years until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

4 years

First QC Date

December 24, 2015

Last Update Submit

December 30, 2017

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Number of muscle cramps

    3 months

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

Gabapentin twice daily

Drug: Gabapentin

PLacebo

PLACEBO COMPARATOR

Calcium carbonate twice daily

Drug: Calcium Carbonate

Interventions

GabapentinDRUG

Gapapentin twice daily

Also known as: Gaptin
Gabapentin
Calcium CarbonateDRUG

calcium carbonate twice daily

Also known as: Calcitron
PLacebo

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • liver cirrhosis patients

You may not qualify if:

  • allergy to gapabentin.
  • pregnancy and lactation. Renal failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta university - faculty of medicine

Tanta, Elgharbia, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

GabapentinCalcium Carbonate

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsCalcium CompoundsInorganic ChemicalsCarbonatesCarbonic AcidCarbon Compounds, InorganicMinerals

Study Officials

  • Sherief M. Abd-Elsalam, Consultant

    Hepatology and gastroenterology dept.-Tanta

    PRINCIPAL INVESTIGATOR

  • A. K. Singal, Professor

    Division of Gastroenterology and Hepatology, UAB, Birmingham, AL, USA

    PRINCIPAL INVESTIGATOR

  • Walaa A. Elkhalawany, Lecturer

    Hepatology and gastroenterology dept.-Tanta

    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 24, 2015

First Posted

December 30, 2015

Study Start

December 1, 2018

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 3, 2018

Record last verified: 2017-12

Locations

EG(1)