High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease
Phase 2
Terminated
- Conditions
- Crohn's Disease
- Interventions
- Drug: PASER placebo granules
- Registration Number
- NCT00417690
- Lead Sponsor
- Jacobus Pharmaceutical
- 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 grams twice daily for 2 weeks, will resolve an acute flare of ileocecal Crohn's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description P PASER placebo granules One packet of oral granules administered three times daily for 2 weeks followed by one packet two times daily for two weeks A 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
- Primary Outcome Measures
Name Time Method Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline 4 weeks
- Secondary Outcome Measures
Name Time Method Rate of remission as defined by the decrease in CDAI > 100 points and total CDAI < 150 by 4 weeks 4 weeks Rate of response as defined by a reduction in HBI to less than 5 by 4 weeks 4 weeks Rate of remission as defined by the decrease in HBI to less than 3 by 4 weeks 4 weeks Time to response and/or remission including time to change in HBI, according to elements of the daily patient diary up to 4 weeks Increase in IBDQ to greater than 170 and the time to score above 170 4 weeks The change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary up to 4 weeks Absence of night time stools, if they were present on entry, and time to disappearance up to 4 weeks Time to normalization of all other components in the diary up to 4 weeks Change in Hgb, ESR, CRP, platelet count, calprotectin from baseline and time to normalization 2 weeks and 4 weeks Change in global physician assessment of disease activity from baseline to study completion 4 weeks
Trial Locations
- Locations (5)
The University of Chicago
🇺🇸Chicago, Illinois, United States
Charlotte Gastroenterology and Hepatology, PLLC
🇺🇸Charlotte, North Carolina, United States
Tel-Aviv Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Mount Sinai School of Medicine IBD Research Center
🇺🇸New York, New York, United States
Rambam Medical Center
🇮🇱Haifa, Israel