Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
Information source: FDA Office of Orphan Products Development
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Crohn's Disease
Intervention: -aminosalicylic acid (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: FDA Office of Orphan Products Development Official(s) and/or principal investigator(s):
James A. Vecchio, Study Chair, Affiliation: University of Vermont
Summary
OBJECTIVES:
I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's
disease of the small bowel.
Clinical Details
Study design: Treatment, Randomized, Placebo Control
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: December 1995
Last updated: June 23, 2005
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