Clinical Trial With Mesalamine 1g Suppositories

Proctitis Clinical Trial

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 mg MESALAMINE, USP) IN THE TREATMENT OF MILD TO MODERATE ULCERATIVE PROCTITIS

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Proctitis

Clinical Trial Details

NCT number	NCT01172444
Study type	Interventional
Source	Sandoz
Contact
Status	Terminated
Phase	Phase 3
Start date	June 2010
Completion date	December 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01966783` - Budesonide vs. Mesalazine vs. Budesonide/Mesalazine Suppository Combination Therapy in Acute Ulcerative Proctitis	Phase 2
Completed	`NCT01008423` - Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis	Phase 3
Completed	`NCT01008410` - Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis	Phase 3
Terminated	`NCT01349673` - The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis	Phase 3
Completed	`NCT01837615` - Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis	Phase 2