Gabapentin to Treat Itch in Patients With Liver Disease

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00058890
First received: April 14, 2003
Last updated: March 17, 2010
Last verified: March 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Study of Gabapentin for the Pruritus of Cholestasis

Resource links provided by NLM:


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
Investigators
Principal Investigator: Nora V Bergasa, M.D. New York Presbyterian Hospital Columbia University College of Physicians and Surgeons
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00058890     History of Changes
Other Study ID Numbers: R03 --9618 (completed 2005)
Study First Received: April 14, 2003
Last Updated: March 17, 2010
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:
Cholestasis
Liver Cirrhosis
Fibrosis
Liver Diseases
Pruritus
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathologic Processes
Skin Diseases
Skin Manifestations
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on April 16, 2014