Phase 4
N=30
Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis
Muscle Cramp · Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT03176966 ↗Enrolled (actual)
30
Serious AEs
2.0%
Results posted
Oct 2022
Primary outcome: Primary: Frequency of Muscle Cramps as Assessed by Patient Survey — 1.14; 1.23 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vitamin E (Drug); Ropinirole (Drug); Muscle cramp survey (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Muscle Cramps as Assessed by Patient Survey |
1.14; 1.23 | — |
| SECONDARY Muscle Cramp Severity as Assessed by Patient Survey |
6.57; 6.00 | — |
Summary
The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the treatment of muscle cramps in cirrhotic patients.
Eligibility Criteria
Inclusion Criteria
- Patients at least 18 years of age in the Vanderbilt Medical Center Hepatology Practice
- diagnosis of cirrhosis
- Self report regular muscle cramping
Exclusion Criteria
- Patients without cirrhosis
- Patients under the age of 18
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT03176966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.