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5-ASA · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| 5 ASA, enemas, suppositories, corticosteroids | DRUG | - |
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. An Institutional Review Board (IRB) approved informed consent is signed and dated prior to any study-related activities. 2. Subject is a male or, if the subject is female, she...
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5-ASA is used for ulcerative colitis, a form of inflammatory bowel disease that affects the colon. It is a small molecule therapy studied in mildly to moderately active disease. The clinical program for 5-ASA in this indication has been run by Bausch Health Companies Inc.
Bausch Health Companies Inc. is the company associated with 5-ASA development. Bausch Health trades on the New York Stock Exchange under the ticker BHC. The company has sponsored the clinical trial program evaluating 5-ASA in ulcerative colitis.
5-ASA is in Phase 3 development for ulcerative colitis. The Phase 3 trial in the program has completed, and no trials are currently listed as active. 5-ASA is an investigational small molecule and is not described here as an approved product.
The 5-ASA program includes the completed Phase 3 trial NCT00269438, titled New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis. It enrolled 225 participants in the United States, was randomized and double blind, and included adults 18 years and older.
5-ASA is also written as 5 ASA. Enemas and suppositories are dosage forms, not separate drug names, and corticosteroids are a different drug class used in ulcerative colitis. Readers searching those terms should note that 5-ASA refers to the same small molecule therapy.
The completed Phase 3 trial of 5-ASA in ulcerative colitis, NCT00269438, enrolled 225 participants. The study was randomized and double blind, took place in the United States, and included male and female adults aged 18 years and older.