drugset / Trial / NCT01172444

Clinical Trial With Mesalamine 1g Suppositories

NCT01172444

Phase 3 Terminated 158 enrolled Sandoz
RandomizedParallel-groupSingle-blindTreatment

Summary

An Investigator-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Establish Therapeutic Equivalence of 1000 mg Mesalamine Rectal Suppositories and Canasa® Rectal Suppositories (1000 mg Mesalamine, USP) in the Treatment of Mild to Moderate Ulcerative Proctitis will be conducted in 533 patient with a estimated duration of 18months.

Timeline

Start
2010-06
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Mesalamine Small molecule 1 g Rectal

Indications