Gabapentin to Treat Itch in Patients With Liver Disease - Full Text View

Sponsor:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00058890

Purpose

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.

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.

Condition	Intervention	Phase
Liver Disease Cholestasis Cirrhosis Pruritus Itching	Drug: gabapentin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Study of Gabapentin for the Pruritus of Cholestasis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis Itching Liver Diseases

Drug Information available for: Gabapentin

U.S. FDA Resources

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:

Change in scratching activity monitoring system

Secondary Outcome Measures:

Change in visual analogue scale for pruritus

Estimated Enrollment:	30
Study Start Date:	November 2000
Estimated Study Completion Date:	January 2004

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 OPD 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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria include:

Patients from ages 18 to 80 with chronic pruritus secondary to liver disease

Patients must have:

a normal chest X- ray during the previous year
normal thyroid function tests (treated thyroid dysfunction is acceptable)
controlled diabetes, if diabetes mellitus is present
negative fecal occult blood within the previous year

Exclusion criteria include:

history of hepatic encephalopathy
decompensated liver disease as suggested by ascites and history of variceal bleeding
malignancy
inability to practice contraception
pregnancy
creatinine > 1.7 mg/dl
hemoglobin < 10mg/dl
S/P liver transplantation
HIV infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058890

Locations

United States, New York
Columbia University College of Physicians and Surgeons
New York, New York, United States, 10032

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Nora V Bergasa, M.D.

New York Presbyterian Hospital Columbia University College of Physicians and Surgeons

More Information

Publications:

Bergasa NV, McGee M, Ginsburg IH, Engler D. Gabapentin in patients with the pruritus of cholestasis: a double-blind, randomized, placebo-controlled trial. Hepatology. 2006 Nov;44(5):1317-23.

Study ID Numbers:	9618
Study First Received:	April 14, 2003
Last Updated:	December 1, 2006
ClinicalTrials.gov Identifier:	NCT00058890 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

itching
pruritus
cholestasis

liver disease
hepatitis
cirrhosis

Additional relevant MeSH terms:

Pruritus
Skin Manifestations
Neurotransmitter Agents
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Gabapentin
Fibrosis
Cholestasis
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Liver Cirrhosis

Membrane Transport Modulators
Signs and Symptoms
Pathologic Processes
Sensory System Agents
Biliary Tract Diseases
Therapeutic Uses
Analgesics
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Skin Diseases
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Digestive System Diseases

ClinicalTrials.gov processed this record on November 25, 2009