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

This study has been completed.
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004423
First received: October 18, 1999
Last updated: March 24, 2015
Last verified: January 2000
  Purpose

OBJECTIVES:

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

  Eligibility

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

PROTOCOL ENTRY CRITERIA:

--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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004423

Sponsors and Collaborators
University of Vermont
Investigators
Study Chair: James A. Vecchio University of Vermont
  More Information

ClinicalTrials.gov 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
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Aminosalicylic Acid
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 28, 2016