NCT00004423

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 1995

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1995

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 1998

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

March 25, 2015

Status Verified

January 1, 2000

First QC Date

October 18, 1999

Last Update Submit

March 24, 2015

Conditions

Crohn's Disease

Keywords

Crohn's diseasegastrointestinal disordersrare disease

Interventions

-aminosalicylic acidDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn DiseaseGastrointestinal DiseasesRare Diseases

Interventions

Aminosalicylic Acid

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisDigestive System DiseasesIntestinal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

para-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAminosalicylic AcidsSalicylatesHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenols

Study Officials

  • James A. Vecchio

    University of Vermont

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

December 1, 1995

Study Completion

March 1, 1998

Last Updated

March 25, 2015

Record last verified: 2000-01