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Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis

Primary Purpose

Liver Cirrhosis

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Gabapentin
Calcium Carbonate
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • liver cirrhosis patients

Exclusion Criteria:

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

Sites / Locations

  • Tanta university - faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gabapentin

PLacebo

Arm Description

Gabapentin twice daily

Calcium carbonate twice daily

Outcomes

Primary Outcome Measures

Number of muscle cramps

Secondary Outcome Measures

Full Information

First Posted
December 24, 2015
Last Updated
December 30, 2017
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT02642484
Brief Title
Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Official Title
Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (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
No
Studies a U.S. FDA-regulated Device Product
No
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. 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.
Detailed Description
• The aim of the study was to assess the efficacy and safety of Gabapentin in the treatment of muscle cramps in patients with liver cirrhosis.

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
Gabapentin
Arm Type
Active Comparator
Arm Description
Gabapentin twice daily
Arm Title
PLacebo
Arm Type
Placebo Comparator
Arm Description
Calcium carbonate twice daily
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Other Intervention Name(s)
Gaptin
Intervention Description
Gapapentin 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
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: liver cirrhosis patients Exclusion Criteria: allergy to gapabentin. pregnancy and lactation. Renal failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief M. Abd-Elsalam, Consultant
Phone
00201095159522
Email
sherif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherief M. Abd-Elsalam, Consultant
Organizational Affiliation
Hepatology and gastroenterology dept.-Tanta
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A. K. Singal, Professor
Organizational Affiliation
Division of Gastroenterology and Hepatology, UAB, Birmingham, AL, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Walaa A. Elkhalawany, Lecturer
Organizational Affiliation
Hepatology and gastroenterology dept.-Tanta
Official's Role
Study Director
Facility Information:
Facility Name
Tanta university - faculty of medicine
City
Tanta
State/Province
Elgharbia
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis

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