Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that has completed, run by Shire. The registered enrollment target is 759 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01124149
The ClinicalTrials.gov registry entry for NCT01124149 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 759 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which MMX mesalamine/ mesalazine is the first listed.
NCT01124149 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.