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NCT00059202 · ClinicalTrials.gov registry record · Phase 2
Trial of High-dose Urso in Primary Sclerosing Cholangitis
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Terminated
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT00059202 is a Phase 2 study that was terminated before completion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 150 participants.
The verdict
NCT00059202, a Phase 2 study, was terminated before completion, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplantation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.
Interventions
- DRUG Placebo
- DRUG Ursodeoxycholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2002-07 |
| Est. Completion | 2008-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00059202
The ClinicalTrials.gov registry entry for NCT00059202 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00059202 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00059202 about?
NCT00059202 is a clinical study titled "Trial of High-dose Urso in Primary Sclerosing Cholangitis". This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplantation, ...
What is the current status of trial NCT00059202?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2002-07. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00059202?
The interventions under investigation include: Placebo (DRUG), Ursodeoxycholic Acid (DRUG).
Who is sponsoring clinical trial NCT00059202?
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.
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