drugset / Trial / NCT01016262

Efficacy and Safety Study of MAX-002 Suppository Versus Placebo and Active Medicine in Mild to Moderate Ulcerative Proctitis

NCT01016262

Phase 3 Terminated 119 enrolled Forest Laboratories
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

EvaluationDrugModalityDoseRoute
Subject Mesalamine Small molecule 1 g Rectal

Indications