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Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: January 2000


I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.

Condition Intervention
Crohn's Disease
Drug: -aminosalicylic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 80
Study Start Date: December 1995
Estimated Study Completion Date: March 1998
Detailed Description:

PROTOCOL OUTLINE: This is a randomized, placebo controlled, multicenter study. Patients are randomized to receive either oral 4-aminosalicylic acid (4-ASA) or placebo twice a day for 12 weeks. After 12 weeks patients who improved with 4-ASA and those who received placebo are given the option of receiving 4-ASA for an additional year.

Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year. Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months, then every 3 months for 1 year.

Completion date provided represents the completion date of the grant per OOPD records


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


--Disease Characteristics--

  • Active small bowel Crohn's disease established by clinical evaluation and prior radiologic study, endoscopy, surgical findings and/or histopathology
  • Crohn's Disease Activity Index (CDAI) must be between 150 and 450
  • No ulcerative or infectious colitis or severe perianal disease

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: Stable dose of no greater than 20 mg per day of prednisone allowed
  • Endocrine therapy: No immunosuppressive drugs within the past 3 months No concurrent immunosuppressive drugs
  • Radiotherapy: Not specified
  • Surgery: No impending surgery No prior ileostomy or colostomy
  • Other: No 5-aminosalicylates within the past 2 weeks No concurrent 5-aminosalicylates No concurrent metronidazol or ciprofloxacin

--Patient Characteristics--

  • Age: 18 to 80
  • Performance status: Ambulatory
  • Hematopoietic: Not specified
  • Hepatic: No hepatic disease
  • Renal: No renal disease
  • Other: Not pregnant (negative pregnancy test required) Fertile patients must use effective contraception No documented salicylate allergy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00004423

Sponsors and Collaborators
University of Vermont
Study Chair: James A. Vecchio University of Vermont
  More Information Identifier: NCT00004423     History of Changes
Other Study ID Numbers: 199/13352  UVTCM-FDR001021 
Study First Received: October 18, 1999
Last Updated: March 24, 2015
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
Crohn's disease
gastrointestinal disorders
rare disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Aminosalicylic Acid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents processed this record on October 21, 2016