Treatment of Muscle Cramps in Patients With Liver Cirrhosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Cirrhosis Muscle Cramps

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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hydroxychloroquine

Group Type EXPERIMENTAL

Hydroxychloroquine

Intervention Type DRUG

daily dosing

Interventions

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Hydroxychloroquine

daily dosing

Intervention Type DRUG

Other Intervention Names

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Plaquenil

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No