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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: Completed Phase 3 study of Cirrhosis and Liver Disease, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A scratching activity monitoring system specifically designed to record scratching behavior independent of gross body movement
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Gabapentin
Study Locations (1)
New York
- Columbia University College of Physicians and Surgeons - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2000-11 |
| Est. Completion | 2004-01 |
| Phase | Phase 3 |
What the finished NCT00058890 record still lists
NCT00058890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 90,409-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cirrhosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00058890's enrollment target sits among peer trials
15 48th of 53 higher than 6 of 53 other Cirrhosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cirrhosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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