Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis
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
Outcome
Met primary endpoint
Stopped (Business): “The decision was taken solely for business/administrative reasons, no safety considerations entered into this. Ongoing randomized patients to complete.”
registry NUMBER MAX-002 (Double-blind Phase): 56.1 percentage of participants NCT01016262 ↗
registry analysis (unspecified test); MAX-002 (Double-blind Phase) vs Placebo (Double-blind Phase); p = 0.0047; Cochran-Mantel-Haenszel NCT01016262 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mesalamine | Small molecule | 1 g | Rectal |