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Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
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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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | December 1995 |
| Estimated Study Completion Date: | March 1998 |
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) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00004423
| 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 |
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 September 21, 2017