Trials / Completed
CompletedNCT00446849
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 IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 290 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MMX Mesalamine | MMX™ mesalamine 2.4g/day to 4.8g/day once-daily (QD) (two to four 1.2g tablets MMX™ mesalamine, dosed QD,respectively). |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2009-08-17
- Completion
- 2009-08-17
- First posted
- 2007-03-13
- Last updated
- 2021-06-14
- Results posted
- 2010-07-08
Locations
62 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00446849. Inclusion in this directory is not an endorsement.