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NCT01124149 · ClinicalTrials.gov registry record · Phase 4
Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis
A Phase 4 study, sponsored by Shire.
- Completed
- Registry status
- Phase 4
- Development phase
- 759
- Enrollment target
NCT01124149: Completed Phase 4 study, sponsored by Shire.
NCT01124149 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 759 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01124149, a Phase 4 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 759 participants
- Enrollment target
Study Summary
This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD. Therefore, subjects who achieve either complete or partial remission will enter into a 12-month maintenance phase, during which they will receive MMX mesalamine/mesalazine 2.4g/day given QD. Remission status for the 2 groups will be evaluated and compared at the end of this 12-month maintenance period. The data obtained from this study will provide scientifically meaningful information to demonstrate that achieving complete remission (clinical and endoscopic remission) is important for a better long-term prognosis, or that the current paradigm of symptomatic treatment is appropriate.
Primary Outcome
Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) \<=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal
Interventions
- DRUG MMX mesalamine/ mesalazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 759 participants |
| Start Date | 2010-06-29 |
| Est. Completion | 2012-12-07 |
| Phase | Phase 4 |
What the finished NCT01124149 record still lists
NCT01124149 is an interventional study that assigns participants to a tested intervention. The registered 759 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (47% higher).
The record links to 0 conditions, and to 1 intervention - of which MMX mesalamine/ mesalazine is the first listed.
NCT01124149 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01124149 about?
NCT01124149 is a clinical study titled "Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis". This study was designed to evaluate if subjects who achieve complete remission after 8 weeks of acute therapy with MMX mesalamine/mesalazine 4.8g/day given QD have better long-term outcomes and remain in remission longer compared with subjects who demonstrate only partial remission after acute thera...
What is the current status of trial NCT01124149?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 759 participants. The study started on 2010-06-29. Estimated completion is 2012-12-07.
What interventions are being tested in trial NCT01124149?
The interventions under investigation include: MMX mesalamine/ mesalazine (DRUG).
Who is sponsoring clinical trial NCT01124149?
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 NCT01124149's enrollment target sits among peer trials
759 106th of 2000 higher than 1,895 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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