High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: 4-Aminosalicylic acid extended release granules
Intervention description: Granules for oral administration will be administered as a volume equivalent to 50 mg/kg of 4-aminosalicylic acid three times daily for 2 weeks followed by 2 times daily for 2 weeks in the active arm or a comparable volume in the placebo arm
Intervention MeSH terms: Aminosalicylic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Crohn's; Crohn's Disease; Acute Flare; Mild to Moderate Crohn's Disease; Children; Pediatrics; Ileo-cecal; Pediatric Crohn's Disease; New Onset Crohn's Disease; Recently diagnosed Crohn's Disease

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 50 milligrams per kilogram three times
      daily for 2 weeks followed by 50 milligrams per kilogram twice daily for 2 weeks, will
      resolve an acute flare of ileocecal Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age less than 18 years

          -  Crohn's disease predominantly involving 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, budesonide

          -  Corticosteroids within 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

          -  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

          -  New fistulization as part of the acute flare or increased activity in chronic
             fistula(e) as part of the acute flare

          -  Hypersensitivity to 4-ASA or any components of PASER®

          -  Pregnancy or breast-feeding

          -  Failure of a woman of child-bearing potential to agree to use adequate contraception
             for the 4 week period of the trial, if sexually active

          -  Severe renal or hepatic disease (i.e., more than 3 times upper limit of normal) or a
             WBC < 3,000 during the preceding three months