Clinical Trial: Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With Cirrhosis
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: Mayo Clinic
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory. [ Time Frame: 28 days after first dose ]
Original Secondary Outcome: Same as current
Information By: Mayo Clinic
Dates:
Date Received: December 16, 2011
Date Started: December 2011
Date Completion:
Last Updated: July 29, 2015
Last Verified: July 2015