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NCT00585312 · ClinicalTrials.gov registry record · Phase 3
Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)
A Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Terminated
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
NCT00585312: Clinical Trial Phase 3 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00585312 is a Phase 3 study that was terminated before completion, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 106 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00585312, a Phase 3 study, was terminated before completion, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
Study Summary
To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).
Primary Outcome
Time to disease progression was defined as the time from randomization to the earliest occurrence of one or more of the following events: 1. Appearance of ≥20 polyps (\>2 mm in size) at any colonoscopy during the study (Polyps); or 2. Diagnosis of colorectal malignancy (ColMal).
Interventions
- DRUG Placebo
- DRUG Celecoxib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2006-09 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
Why NCT00585312 stopped before completion
NCT00585312 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00585312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00585312 about?
NCT00585312 is a clinical study titled "Trial In Pediatric Patients With Familial Adenomatous Polyposis (FAP)". To test whether celecoxib can be used to prevent colon polyp formation in children with familial adenomatous polyposis (FAP).
What is the current status of trial NCT00585312?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2006-09. Estimated completion is 2013-10.
What interventions are being tested in trial NCT00585312?
The interventions under investigation include: Placebo (DRUG), Celecoxib (DRUG).
Who is sponsoring clinical trial NCT00585312?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00585312's enrollment target sits among peer trials
106 1666th of 2000 higher than 331 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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