Treatment of Muscle Cramps in Patients With Liver Cirrhosis
This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with patients having cramps due to their cirrhotic liver disease.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With Cirrhosis|
- frequency and severity of muscle cramps in cirrhotic patients reporting the symptom, based on the modified muscle cramps questionnaire (mMCQ) [ Time Frame: 1 month after completion of questionnaire ] [ Designated as safety issue: No ]Patients will be given the mMCQ and SF-12 to complete. These instruments will be scored according to established algorithms. Data analysis will include descriptive statistics (frequency, duration and severity of muscle cramps) and correlation between overall quality of life and the mMCQ summary score.
- safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory. [ Time Frame: 28 days after first dose ] [ Designated as safety issue: No ]The study intervention will include open label HCQ daily, which will be provided for the patients for two weeks. A designated coordinator will contact the patient 2 and 7 days of the study to ask of adverse events and fill out the AE inventory. At the end of the dosing, patients will be asked to return to the clinic for post-intervention assessment, which will include the mMCQ, SF-12, systemic AE inventory, CBC and EKG. Designated coordinator will contact patient again on day 28 of the study to ask mMCQ, SF-12, AE inventory.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Other Name: Plaquenil
This project is proposed as a pilot study to gather preliminary data for a full-scale randomized trial to assess the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of muscle cramps in patients with cirrhosis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495403
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Patrick Kamath, MD||Mayo Clinic|