Trials / Completed
CompletedNCT02522780
Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 276 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC. The duration of treatment for each subject was 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mesalamine | Pharmaceutical form: Granules in sachet; Route of administration: Oral use |
| DRUG | Placebo | Pharmaceutical form: Granules in sachet; Route of administration: Oral use |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2018-09-19
- Completion
- 2018-09-19
- First posted
- 2015-08-13
- Last updated
- 2021-11-08
- Results posted
- 2021-09-14
Locations
96 sites across 11 countries: United States, Bulgaria, Canada, Hungary, Latvia, Mexico, Poland, Russia, Serbia, Switzerland, Ukraine
Source: ClinicalTrials.gov record NCT02522780. Inclusion in this directory is not an endorsement.