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NCT00004842 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis
A Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00004842: Completed Phase 1 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00004842 is a Phase 1 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004842, a Phase 1 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid. II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial.
Interventions
- DRUG budesonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 1997-05 |
| Est. Completion | 1999-04 |
| Phase | Phase 1 |
What the finished NCT00004842 record still lists
NCT00004842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which budesonide is the first listed.
NCT00004842 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004842 about?
NCT00004842 is a clinical study titled "Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis". OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid. II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the fe...
What is the current status of trial NCT00004842?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 1997-05. Estimated completion is 1999-04.
What interventions are being tested in trial NCT00004842?
The interventions under investigation include: budesonide (DRUG).
Who is sponsoring clinical trial NCT00004842?
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00004842's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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