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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
Sponsor:
Information provided by:
FDA Office of Orphan Products Development

Study Description
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Brief Summary:

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

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.

Completion date provided represents the completion date of the grant per OOPD records


Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Primary Purpose: Treatment
Study Start Date : December 1995
Study Completion Date : March 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Vermont
Investigators
Study Chair: James A. Vecchio University of Vermont
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00004423     History of Changes
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

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