Completed

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

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What is being tested

-aminosalicylic acid

Drug
Who is being recruted

Colitis+9

+ Colonic Diseases

+ Digestive System Diseases

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 1996
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1996

Actual date on which the first participant was enrolled.

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.

NCT00004810
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ColitisColonic DiseasesDigestive System DiseasesGastroenteritisIntestinal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsInflammatory Bowel DiseasesDisease AttributesColitis, UlcerativeGastrointestinal DiseasesRare Diseases

Criteria

PROTOCOL ENTRY CRITERIA: Mildly to moderately severe ulcerative colitis Patient age: 18 to 80

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers