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

This study is ongoing, but not recruiting participants.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development University of Vermont
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004423

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

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: p-Aminosalicylic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Placebo Control

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	80
Study Start Date:	December 1995

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

Ages Eligible for Study:	18 Years to 80 Years
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

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

Sponsors and Collaborators

FDA Office of Orphan Products Development

University of Vermont

Investigators

Study Chair:

James A. Vecchio

University of Vermont

More Information

No publications provided

Study ID Numbers:	199/13352, UVTCM-FDR001021
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004423 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

Crohn's disease
gastrointestinal disorders
rare disease

Study placed in the following topic categories:

Crohn's Disease
Ileitis
Gastrointestinal Diseases
Enteritis
Rare Diseases
Inflammatory Bowel Diseases
Intestinal Diseases

Ileal Diseases
Anti-Bacterial Agents
Digestive System Diseases
P-Aminosalicylic Acid
Crohn Disease
Antitubercular Agents
Gastroenteritis

Additional relevant MeSH terms:

Anti-Infective Agents
Ileitis
Gastrointestinal Diseases
Enteritis
Inflammatory Bowel Diseases
Intestinal Diseases
Ileal Diseases
Pharmacologic Actions

Anti-Bacterial Agents
Digestive System Diseases
Therapeutic Uses
P-Aminosalicylic Acid
Crohn Disease
Antitubercular Agents
Gastroenteritis

ClinicalTrials.gov processed this record on May 07, 2009