Status:
TERMINATED
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease
Lead Sponsor:
Jacobus Pharmaceutical
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 4 grams three times daily for 2 weeks followed by 4 ...
Eligibility Criteria
Inclusion
- Age 18-65
- 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
- Concomitant corticosteroids, including budesonide
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00417690
Start Date
January 1 2007
End Date
October 1 2008
Last Update
October 15 2008
Active Locations (5)
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1
The University of Chicago
Chicago, Illinois, United States, 60637
2
Mount Sinai School of Medicine IBD Research Center
New York, New York, United States, 10028
3
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States, 28207
4
Rambam Medical Center
Haifa, Israel, 31096