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Gabapentin to Treat Itch in Patients With Liver Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00058890
First Posted: April 16, 2003
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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 (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.


Condition Intervention Phase
Liver Disease Cholestasis Cirrhosis Pruritus Itching Drug: Gabapentin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 [ Time Frame: 4 weeks ]
    A scratching activity monitoring system specifically designed to record scratching behavior independent of gross body movement


Secondary Outcome Measures:
  • Change in visual analogue scale for pruritus [ Time Frame: 4 weeks ]

Enrollment: 15
Actual Study Start Date: November 2000
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gabapentin Drug: Gabapentin
Under code, the study drug was started at 100 mg by mouth 3 times a day for 3 days, to be increased, if necessary and in the absence of side effects, by 300 mg every 3 days to a maximum of 2,400 mg daily in divided doses.
Placebo Comparator: Placebo Drug: Placebo

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00058890     History of Changes
Other Study ID Numbers: R03 --9618 (completed 2005)
R03DK055618 ( U.S. NIH Grant/Contract )
First Submitted: April 14, 2003
First Posted: April 16, 2003
Last Update Posted: October 13, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
itching
pruritus
cholestasis
liver disease
hepatitis
cirrhosis

Additional relevant MeSH terms:
Fibrosis
Liver Diseases
Pruritus
Cholestasis
Pathologic Processes
Digestive System Diseases
Skin Diseases
Skin Manifestations
Signs and Symptoms
Bile Duct Diseases
Biliary Tract Diseases
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents