Crohn's Disease
Conditions
Keywords
Crohn's Disease, Acute Flare, Mild to moderate Crohn's Disease, Ileocecal distribution
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.
Interventions
DRUG4-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
DRUGPASER 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
Sponsors
Jacobus Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response, as defined by a reduction of the CDAI score of >70 points by 4 weeks compared with baseline | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Rate of remission as defined by the decrease in CDAI > 100 points and total CDAI < 150 by 4 weeks | 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 |
| The change from baseline in the patient's general sense of disease activity as recorded in the individual daily diary | up to 4 weeks |
Countries
Israel, United States
Outcome results
None listed