Treatment of Muscle Cramps in Patients With Liver Cirrhosis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Patrick Kamath, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01495403
First received: December 16, 2011
Last updated: June 5, 2014
Last verified: June 2014

December 16, 2011
June 5, 2014
December 2011
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01495403 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Treatment of Muscle Cramps in Patients With Liver Cirrhosis
A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With 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.

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.

Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Liver Cirrhosis
  • Muscle Cramps
Drug: Hydroxychloroquine
daily dosing
Other Name: Plaquenil
Experimental: hydroxychloroquine
Intervention: Drug: Hydroxychloroquine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10
June 2016
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • previous diagnosis of cirrhosis
  • adult (>21 years)
  • able to complete a written questionnaire in English
  • stable and ambulatory
  • MELD score < 25, Platelet count >25,000

Exclusion Criteria:

  • people allergic to hydroxychloroquine, 4-aminoquinolone derivatives or any component of the formulation
  • previous diagnosis of retinal or visual field changes attributable to 4-aminoquinolone
  • previous diagnosis of porphyria
  • previous diagnosis of psoriasis
  • fulminant hepatic failure
  • pregnant women
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01495403
11-002743
No
Patrick Kamath, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Patrick Kamath, MD Mayo Clinic
Mayo Clinic
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP