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NCT02093663 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 107
- Enrollment target
NCT02093663: Completed Phase 3 study, sponsored by Shire.
NCT02093663 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 107 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
NCT02093663, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 107 participants
- Enrollment target
Study Summary
To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.
Primary Outcome
Clinical response was defined as partial ulcerative colitis disease activity index (UC-DAI) score \< or =1 with rectal bleeding = 0, stool frequency \< or =1, and physician's global assessment (PGA = 0). Number of participants with clinical response were reported.
Interventions
- DRUG MMX Mesalamine/Mesalazine (Low Dose)
- DRUG MMX Mesalamine/Mesalazine (High Dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2014-12-12 |
| Est. Completion | 2018-11-28 |
| Phase | Phase 3 |
What the finished NCT02093663 record still lists
NCT02093663 is an interventional study that assigns participants to a tested intervention. The registered 107 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 MMX Mesalamine/Mesalazine (Low Dose) is the first listed.
NCT02093663 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02093663 about?
NCT02093663 is a clinical study titled "Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis". To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.
What is the current status of trial NCT02093663?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 107 participants. The study started on 2014-12-12. Estimated completion is 2018-11-28.
What interventions are being tested in trial NCT02093663?
The interventions under investigation include: MMX Mesalamine/Mesalazine (Low Dose) (DRUG), MMX Mesalamine/Mesalazine (High Dose) (DRUG).
Who is sponsoring clinical trial NCT02093663?
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 NCT02093663's enrollment target sits among peer trials
107 1666th of 2000 higher than 335 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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