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

Crohn's Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004423
• Other study ID #: 199/13352
• Secondary ID: UVTCM-FDR001021
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: December 1995
• Est. completion date: March 1998

Study information

• Verified date: January 2000
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES:

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• -aminosalicylic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont