Gabapentin to Treat Itch in Patients With Liver Disease

NCT ID: NCT00058890

Last Updated: 2017-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2004-01-31

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.

Conditions

Liver Disease; Cholestasis; Cirrhosis; Pruritus; Itching

Keywords

itching; pruritus; cholestasis; liver disease; hepatitis; cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Gabapentin

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: DRUG

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

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.

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nora V Bergasa, M.D.

Role: PRINCIPAL_INVESTIGATOR

New York Presbyterian Hospital Columbia University College of Physicians and Surgeons

Locations

Columbia University College of Physicians and Surgeons

New York, New York, United States

Countries

United States

References

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. doi: 10.1002/hep.21370.

Reference Type: RESULT

PMID: 17058231 (View on PubMed)

Other Identifiers

R03DK055618

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R03 --9618 (completed 2005)

Identifier Type: -

Identifier Source: org_study_id