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NCT00446849 · ClinicalTrials.gov registry record · Phase 4
Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)
A Phase 4 study, sponsored by Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 290
- Enrollment target
NCT00446849: Completed Phase 4 study, sponsored by Shire.
NCT00446849 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 290 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00446849, a Phase 4 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 290 participants
- Enrollment target
Study Summary
To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.
Primary Outcome
Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.
Interventions
- DRUG MMX Mesalamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 290 participants |
| Start Date | 2007-05-01 |
| Est. Completion | 2009-08-17 |
| Phase | Phase 4 |
What the finished NCT00446849 record still lists
NCT00446849 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 1 intervention - of which MMX Mesalamine is the first listed.
NCT00446849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00446849 about?
NCT00446849 is a clinical study titled "Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)". To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.
What is the current status of trial NCT00446849?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 290 participants. The study started on 2007-05-01. Estimated completion is 2009-08-17.
What interventions are being tested in trial NCT00446849?
The interventions under investigation include: MMX Mesalamine (DRUG).
Who is sponsoring clinical trial NCT00446849?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00446849's enrollment target sits among peer trials
290 297th of 2000 higher than 1,703 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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