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NCT00058890 · ClinicalTrials.gov registry record · Phase 3

Gabapentin to Treat Itch in Patients With Liver Disease

A Phase 3 study of Cirrhosis and Liver Disease, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
Phase 3
Development phase
15
Enrollment target
1
Study location

NCT00058890 is a Phase 3 study of Cirrhosis and Liver Disease that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 15 participants, below the 90,409-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00058890, a Phase 3 study of Cirrhosis and Liver Disease, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
Phase 3
Development phase
15 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Gabapentin

Study Locations (1)

New York

  • Columbia University College of Physicians and Surgeons - New York

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2000-11
Est. Completion 2004-01
Phase Phase 3

What the Registry Record Tells You About NCT00058890

The ClinicalTrials.gov registry entry for NCT00058890 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90,409-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00058890 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00058890 about?

NCT00058890 is a clinical study titled "Gabapentin to Treat Itch in Patients With Liver Disease". 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 liv...

What is the current status of trial NCT00058890?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2000-11. Estimated completion is 2004-01.

What conditions does trial NCT00058890 study?

This clinical trial studies the following conditions: Cirrhosis, Liver Disease, Pruritus, Cholestasis, Itching.

What interventions are being tested in trial NCT00058890?

The interventions under investigation include: Placebo (DRUG), Gabapentin (DRUG).

Who is sponsoring clinical trial NCT00058890?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00058890 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.