Back to resultsCyclobenzaprine in Muscle Cramps With Liver Cirrhosis
Primary Purpose
Liver Cirrhosis
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Cyclobenzaprine
Calcium Carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Liver cirrhosis and has frequent muscle cramps
Exclusion Criteria:
- Allergy to cyclobenzaprine
- Encephalopathy.
- Receiving antidepressant drugs
Sites / Locations
- Tanta university - faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cyclobenzaprine
PLacebo
Arm Description
Cyclobenzaprine administration for 2 weeks
Calcium carbonate for 2 weeks
Outcomes
Primary Outcome Measures
Number of muscle cramps
The number of muscle cramps
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02642861
Brief Title
Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis
Official Title
Cyclobenzaprine Treatment for Muscle Cramps in Cirrhotic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (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
- Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.
Detailed Description
Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking.
- Cyclobenzaprine, is a muscle relaxer medication used to relieve skeletal muscle spasms. It is one of the best-studied drug for this application.
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
Cyclobenzaprine
Arm Type
Active Comparator
Arm Description
Cyclobenzaprine administration for 2 weeks
Arm Title
PLacebo
Arm Type
Placebo Comparator
Arm Description
Calcium carbonate for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Cyclobenzaprine
Other Intervention Name(s)
cyclosed
Intervention Description
cyclobenzaprine administration for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Calcium Carbonate
Other Intervention Name(s)
Calcitron
Intervention Description
Calcium carbonate for 2 weeks
Primary Outcome Measure Information:
Title
Number of muscle cramps
Description
The 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
No
Eligibility Criteria
Inclusion Criteria:
Liver cirrhosis and has frequent muscle cramps
Exclusion Criteria:
Allergy to cyclobenzaprine
Encephalopathy.
Receiving antidepressant drugs
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
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
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis
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