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NCT00217022 · ClinicalTrials.gov registry record · Phase 2
Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis
A Phase 2 study, sponsored by Mayo Clinic.
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT00217022: Clinical Trial Phase 2 study, sponsored by Mayo Clinic.
NCT00217022 is a Phase 2 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00217022, a Phase 2 study, was terminated before completion, sponsored by Mayo Clinic.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis. This study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy. The study hypothesis is that budesonide will be safe and effective compared with placebo for the treatment of diarrhea in lymphocytic colitis.
Primary Outcome
Subjects were asked if they felt they had satisfactory control of their diarrhea, along with the number of stools and type of stool (loose, water, formed, hard) the patient were experiencing. The rating of "satisfactory control" of diarrhea was therefore a partially subjective measure. This outcome measure was to be recorded for three out of the last four weeks that a subject was on the study; subjects were to take part in the study approximately 8 weeks.
Interventions
- OTHER Placebo
- DRUG Budesonide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2003-06 |
| Est. Completion | 2008-02 |
| Phase | Phase 2 |
Why NCT00217022 stopped before completion
NCT00217022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00217022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00217022 about?
NCT00217022 is a clinical study titled "Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis". Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis. This study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy. The study hypothesis is that budesonide will be safe and effective compared with placebo for the treatment of di...
What is the current status of trial NCT00217022?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2003-06. Estimated completion is 2008-02.
What interventions are being tested in trial NCT00217022?
The interventions under investigation include: Placebo (OTHER), Budesonide (DRUG).
Who is sponsoring clinical trial NCT00217022?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00217022's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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