NCT00058890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2000

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

3.2 years

First QC Date

April 14, 2003

Last Update Submit

October 12, 2017

Conditions

Liver DiseaseCholestasisCirrhosisPruritusItching

Keywords

itchingprurituscholestasisliver diseasehepatitiscirrhosis

Outcome Measures

Primary Outcomes (1)

  • Change in scratching activity monitoring system

    A scratching activity monitoring system specifically designed to record scratching behavior independent of gross body movement

    4 weeks

Secondary Outcomes (1)

  • Change in visual analogue scale for pruritus

    4 weeks

Study Arms (2)

Gabapentin

EXPERIMENTAL
Drug: Gabapentin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

GabapentinDRUG

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.

Gabapentin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University College of Physicians and Surgeons

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 17058231RESULT

MeSH Terms

Conditions

Liver DiseasesCholestasisFibrosisPruritusHepatitis

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Digestive System DiseasesBile Duct DiseasesBiliary Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Nora V Bergasa, M.D.

    New York Presbyterian Hospital Columbia University College of Physicians and Surgeons

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2003

First Posted

April 16, 2003

Study Start

November 1, 2000

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

US(1)