Trials / Terminated
TerminatedNCT01172444
Clinical Trial With Mesalamine 1g Suppositories
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2010-06-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2010-07-29
- Last updated
- 2017-03-27
Locations
38 sites across 1 country: India
Source: ClinicalTrials.gov record NCT01172444. Inclusion in this directory is not an endorsement.