Gabapentin to Treat Itch in Patients With Liver Disease

Phase 3

Completed

• Conditions: Pruritus; Liver Disease; Itching; Cirrhosis; Cholestasis
• Interventions: Drug: Placebo; Drug: Gabapentin

• Registration Number: NCT00058890
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

In this study, the effect of the medication gabapentin to treat itching secondary to liver disease is being studied.

There are some funds to cover travel expenses for patients who are not from New York (NY).

Gabapentin is approved to treat seizures in human beings. In this study, patients with liver disease who meet inclusion criteria are admitted to the research hospital of the New York Presbyterian Hospital to record scratching behavior by the use of a machine designed for that purpose. Blood work will be obtained. After completion of recording, patients are assigned by chance to receive active medication or placebo (a capsule that does not contain active medication). The patients will come to the outpatient office of the research hospital 2 weeks into the study for an interview and blood work. After 4 weeks, patients are readmitted to the hospital to record scratching behavior. After data are collected, the code is broken, if patient had been on inactive drug, active drug will be supplied as per protocol for 4 weeks. Blood work will be obtained. If patient had been randomized to active medication, the study will provide one week supply of drug. After that, the referring physician, with whom the study was previously discussed, could prescribe the medication as it is available.

Detailed Description

Double-blind, randomized, placebo-controlled study of gabapentin for the pruritus of cholestasis. Duration: 4 weeks. Some travel funds available for patients from out of the NY area for all the visits. Hospitalization at baseline and after 4 weeks of treatment. One outpatient department visit at week 2.

All patients have to be referred by their physician, who will receive a summary of the results at the end of the patient's study participation.

If patients are randomized to active drug and respond to it with decrease in pruritus, a one week supply of medication is given. The referring physician could prescribe the drug for long term use. If the patient is randomized to placebo they can be treated with active medication provided by the study for 4 weeks, at end of which, the drug could be prescribed by referring physician if the patient responds to the drug with decrease in the pruritus.

Study Timeline

• Study Start: 2000-11
• Study First Submitted: 2003-04-14
• Study First Submitted QC: 2003-04-15
• Study First Posted: 2003-04-16
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-12
• Last Update Posted: 2017-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Gabapentin	Gabapentin	-

Primary Outcome Measures

Name	Time	Method
Change in scratching activity monitoring system	4 weeks	A scratching activity monitoring system specifically designed to record scratching behavior independent of gross body movement

Secondary Outcome Measures

Name	Time	Method
Change in visual analogue scale for pruritus	4 weeks

Trial Locations

Locations (1)

Columbia University College of Physicians and Surgeons; 🇺🇸 New York, New York, United States