Status:
COMPLETED
Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis
Lead Sponsor:
Wolfson Medical Center
Conditions:
Mild to Moderate Ulcerative Colitis
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate effectiveness of once daily dosing of Pentasa compared with twice daily in children with mild to moderate active ulcerative colitis.
Detailed Description
Several randomized controlled trials (RCTs) have affirmed the efficacy of 5-aminosalicylic acid (5-ASA) and sulfasalazine in the acute treatment of mild to moderate exacerbations, as well as in the ma...
Eligibility Criteria
Inclusion
- Children 6-18 years of age, weight least 15kg.
- Diagnosis of UC, established by the presence of accepted clinical, radiologic, endoscopic and histologic criteria.
- Mild to moderate disease activity at the time of enrolment as judged by the Pediatric UC Activity Index (PUCAI) score 10-55 points.
- In general good health (other than the diagnosis of UC), based on medical history, physical examination, and screening laboratory results.
- Infectious colitis excluded by stool cultures, ova and parasite examination and Clostridium difficile assay.
- Ability and acceptance to participate in the study and follow study procedures, as evidenced by a parent/legal guardian signing a written informed consent and the child providing assent.
Exclusion
- Weight \<15 kg at enrolment
- Patients whose disease is confined to the rectum (i.e. proctitis).
- Fever \>38.5 degrees.
- Patients with Crohn's colitis or with IBD type unclassified (IBD-U) according to Montreal classification.
- Treatment with oral 5-ASA oral preparation with at least 50mg/kg/day \> 3 days within 7 days prior to screening visit. Patients who are treated with 5-ASA \<50mg/kg/d may be enrolled as their dose will be increased significantly in this trial. A sensitivity analysis is planned including only 5-ASA naïve children.
- Exacerbation associated with infectious organism in the stool.
- Current treatment with steroids (any dose) or the need for steroid therapy as judged by the responsible gastroenterologist.
- Rectal therapies (suppositories, foams, enemas etc) of all kind are allowed if the dose and frequency has remained stable during the previous 30 days prior to the screening visit. No changes are allowed after randomization and until completion of the study.
- Treatment with immunomodulatory therapy including, but not limited to: 6 mercaptopurine (6-MP), azathioprine, cyclosporine, tacrolimus, rosiglitazone or methotrexate, is allowed if the dose and frequency has remained stable during the previous 90 days prior to the screening visit. No changes are allowed after randomization and until completion of the study.
- Treatment with biologic therapy including, but not limited to: infliximab, certolizumab, adalimumab within 90 days prior to screening visit.
- Pregnancy. All female patients of childbearing potential will undergo urine pregnancy testing at screening, must not be lactating, and willing to use acceptable contraception if sexually active.
- Known allergy to 5ASA, salicylates, or aminosalicylates.
- Existence of current renal disease, or a screening blood urea nitrogen (BUN) or creatinine value that is \> 1.5 times the upper limit of the age appropriate normal.
- Existence of current hepatic disease, or liver tests (ALT, AST, T-Bili) that are \> 2 times the upper limit of normal, or the existence of Primary Sclerosing Cholangitis (PSC).
- History of recurrent pancreatitis.
- Any other laboratory or clinical condition that the investigator considers clinically significant that would impact the outcome of the study or the safety of the patient.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01201122
Start Date
September 1 2010
End Date
December 1 2015
Last Update
December 8 2015
Active Locations (1)
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1
Wolfson Medical Center
Holon, Israel, 58100