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Clinical Trial With Mesalamine 1g Suppositories

NCT01172444 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2017-03-27

No results posted yet for this study

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.

Conditions

  • Proctitis

Interventions

DRUG

Mesalamine

Supporitory, Once Daily, Per Rectal for 6 Weeks

DRUG

Canasa

Suppository, Once Daily, Per Rectal for 6 Weeks

DRUG

Placebo

Suppository, Once Daily, Per Rectal for 6 Weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01172444 on ClinicalTrials.gov