Clinical Trial: Clinical Trial With Mesalamine 1g Suppositories

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: AN INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ESTABLISH THERAPEUTIC EQUIVALENCE OF 1000 mg MESALAMINE RECTAL SUPPOSITORIES AND CANASA® RECTAL SUPPOSITORIES (1000

Brief 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.

Detailed Summary:
Sponsor: Sandoz

Current Primary Outcome: DAI Score [ Time Frame: 6 Weeks ]

Mean difference in the DAI score between Baseline and the Final Visit.


Original Primary Outcome: Same as current

Current Secondary Outcome: DAI Score, Improvement, Remission & Histological Disease Activity Score [ Time Frame: 3 and 6 Weeks ]

  • The mean difference in the DAI score and each of the individual DAI parameters between Baseline, Interim and Final Visits
  • Proportion of patients achieving an "improvement", defined as a ≥3 point improvement in overall DAI score and the proportion of patients achieving a "remission", where "remission" is defined as a DAI score of 0-1 at the Interim and Final Visit.
  • The mean difference in the histological disease activity score between baseline and the Final Visit


Original Secondary Outcome: Same as current

Information By: Sandoz

Dates:
Date Received: July 28, 2010
Date Started: June 2010
Date Completion:
Last Updated: March 22, 2017
Last Verified: July 2015