Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
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ClinicalTrials.gov Identifier: NCT00004423 |
Recruitment Status :
Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
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OBJECTIVES:
I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's disease of the small bowel.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: -aminosalicylic acid | Not Applicable |
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
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 80 participants |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Study Start Date : | December 1995 |
Study Completion Date : | March 1998 |


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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004423
Study Chair: | James A. Vecchio | University of Vermont |
ClinicalTrials.gov Identifier: | NCT00004423 |
Other Study ID Numbers: |
199/13352 UVTCM-FDR001021 |
First Posted: | October 19, 1999 Key Record Dates |
Last Update Posted: | March 25, 2015 |
Last Verified: | January 2000 |
Crohn's disease gastrointestinal disorders rare disease |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Aminosalicylic Acid Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents |