High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease
NCT ID: NCT00417690
Last Updated: 2008-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
54 participants
INTERVENTIONAL
2007-01-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks
4-Aminosalicylic acid
Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks
P
One packet of oral granules administered three times daily for 2 weeks followed by one packet two times daily for two weeks
PASER placebo granules
Oral granules administered administered as one packet three times daily for two weeks followed by one packet two times daily for two weeks
Interventions
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4-Aminosalicylic acid
Oral granules administered as one 4 g packet three times daily for two weeks followed by one 4 g packet two times daily for two weeks
PASER placebo granules
Oral granules administered administered as one packet three times daily for two weeks followed by one packet two times daily for two weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Crohn's disease involving predominantly the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist.
* Harvey Bradshaw Index of at least 7
* The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry.
* Written informed consent
Exclusion Criteria
* Corticosteroids within the previous 2 months
* Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months
* Maintenance infliximab, or infliximab or other biologics in the preceding 3 months
* Change in dose during previous 4 weeks in 5-aminosalicylate, probiotic and/or antibiotic, or in chronic azathioprine, 6-mercaptopurine, or methotrexate
* If currently using azathioprine, 6-mercaptopurine or methotrexate, these must have been used steadily for at least 4 months
* Current experimental drugs or experimental drugs within the last 3 months
* If the severity of the flare has started to decrease spontaneously
* Coexisting diagnosis of primary sclerosing cholangitis,
* Infectious diarrhea,
* Signs of intestinal obstruction or perforation or abscess,
* New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare,
* Increased activity of pre-existing anal or rectal Crohn's disease as part of the flare
* Allergy or sensitivity to salicylates
* Pregnancy or breast-feeding
* Failure of a woman of child-bearing age to agree to use adequate contraception for the 4 week period of the trial, if sexually active
* Severe renal or hepatic disease
18 Years
65 Years
ALL
No
Sponsors
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Jacobus Pharmaceutical
INDUSTRY
Responsible Party
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Jacobus Pharmaceutical Company, Inc.
Principal Investigators
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David P. Jacobus, MD
Role: STUDY_CHAIR
Jacobus Pharmaceutical
Kathy L. Ales, MD
Role: STUDY_DIRECTOR
Jacobus Pharmaceutical
Daniel Present, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Stephen B. Hanauer, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago Hospitals
John Hanson, MD
Role: PRINCIPAL_INVESTIGATOR
Charlotte Gastroenterology & Hepatology, PLLC
Iris Dotan, MD
Role: PRINCIPAL_INVESTIGATOR
Tel-Aviv Sourasky Medical Center
Rami Eliakim, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Locations
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The University of Chicago
Chicago, Illinois, United States
Mount Sinai School of Medicine IBD Research Center
New York, New York, United States
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States
Rambam Medical Center
Haifa, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Other Identifiers
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PASER-AFC.001
Identifier Type: -
Identifier Source: org_study_id