Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT00004810|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: -aminosalicylic acid||Phase 2|
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by extent of disease.
Patients are randomly assigned to oral 4-aminosalicylic acid (4-ASA) or placebo administered daily for 6 weeks. Optional 4-ASA is available to all patients for up to 1 year.
Concurrent therapy with low-dose sulfasalazine, prednisone, or equivalent is allowed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Study Start Date :||June 1996|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004810
|Study Chair:||Warren L. Beeken||University of Vermont|