Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Sponsor
Tanta University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT02642484
Collaborator
(none)
200
1
2
48
4.2
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Anticipated Study Start Date
:
Dec 1, 2018
Anticipated Primary Completion Date
:
Dec 1, 2022
Anticipated Study Completion Date
:
Dec 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Gabapentin Gabapentin twice daily |
Drug: Gabapentin
Gapapentin twice daily
Other Names:
|
| Placebo Comparator: PLacebo Calcium carbonate twice daily |
Drug: Calcium Carbonate
calcium carbonate twice daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of muscle cramps [3 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- liver cirrhosis patients
Exclusion Criteria:
-
allergy to gapabentin.
-
pregnancy and lactation. Renal failure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tanta university - faculty of medicine | Tanta | Elgharbia | Egypt |
Sponsors and Collaborators
- Tanta University
Investigators
- Principal Investigator: 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
- Study Director: Walaa A. Elkhalawany, Lecturer, Hepatology and gastroenterology dept.-Tanta
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sherief Abd-Elsalam,
Consultant liver and GIT diseases- Tanta university hospital,
Tanta University
ClinicalTrials.gov Identifier:
NCT02642484
Other Study ID Numbers:
- Sherief Abd-Elsalam
First Posted:
Dec 30, 2015
Last Update Posted:
Jan 3, 2018
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: