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CompletedNCT00004810Updated Jun 24, 2005

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

A Phase 2 interventional study of -aminosalicylic acid in Ulcerative Colitis, sponsored by National Center for Research Resources (NCRR). Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by National Center for Research Resources (NCRR) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

OBJECTIVES:

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

Read the detailed description

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.

02

Conditions studied

  • Ulcerative Colitis

Keywords

  • gastrointestinal disorders
  • rare disease
  • ulcerative colitis
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

National Center for Research Resources (NCRR) is the lead sponsor of 265 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

PROTOCOL ENTRY CRITERIA:

  • Mildly to moderately severe ulcerative colitis
  • Patient age: 18 to 80
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Enrollment
30 participants

Interventions

  • Drug-aminosalicylic acid
06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 9052519 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00004810
Lead sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Vermont
First posted
Feb 25, 2000
Start date
Jun 1996
Last update
Jun 24, 2005

Study contacts

Warren L. Beeken
study chair · University of Vermont
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2001. You cannot join it, but the record below documents what was studied.

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