drugset / Trial / NCT01016262
Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a prospective, multicenter, double-blind (DB), controlled, randomized, parallel group comparison Phase 3a study to evaluate the efficacy and safety of new mesalamine suppositories (MAX-002) as compared to placebo and active medicine after 6 weeks of treatment in adults with mild to moderate ulcerative proctitis (UP).
Timeline
- Start
- 2009-11-30
- Primary completion
- 2011-07-31
- Completion
- 2011-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mesalamine | Small molecule | 1 g | Rectal |