Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-06-30

Brief Summary

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OBJECTIVES:

I. Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.

Detailed Description

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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.

Conditions

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Ulcerative Colitis

Keywords

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gastrointestinal disorders rare disease ulcerative colitis

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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-aminosalicylic acid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

PROTOCOL ENTRY CRITERIA:

* Mildly to moderately severe ulcerative colitis
* Patient age: 18 to 80

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Warren L. Beeken

Role: STUDY_CHAIR

University of Vermont

References

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Beeken W, Howard D, Bigelow J, Trainer T, Roy M, Thayer W, Wild G. Controlled trial of 4-ASA in ulcerative colitis. Dig Dis Sci. 1997 Feb;42(2):354-8. doi: 10.1023/a:1018874120749.

Reference Type BACKGROUND

PMID: 9052519 (View on PubMed)

Other Identifiers

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UVT-12012

Identifier Type: -

Identifier Source: secondary_id

199/12012