Cirrhosis Clinical Trial
Official title:
Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis
Verified date | September 2022 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the treatment of muscle cramps in cirrhotic patients.
Status | Completed |
Enrollment | 31 |
Est. completion date | October 22, 2021 |
Est. primary completion date | October 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of Muscle Cramps as Assessed by Patient Survey | Compare the incidence of muscle cramps in patients using vitamin E versus ropinirole. Patients complete a survey that assesses the frequency of muscle cramps from once weekly or less to multiple episodes per day. Frequency scale is 0 to 3 with 0 being once weekly or less and 3 being multiple episodes a day. Survey is completed at the end of 3 months on study intervention. | 3 months | |
Secondary | Muscle Cramp Severity as Assessed by Patient Survey | Compare the severity of muscle cramps in patients using vitamin E versus ropinirole. Patients complete a survey that assesses muscle cramp pain on a scale from 0 to 10 with 0 being no pain and 10 being hurts worst. Survey is completed at the end of 3 months of study intervention. | 3 months |
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