Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 21 December 2015
• Main ID: NCT01201122
• Date of registration: 12/09/2010
• Prospective Registration: No
• Primary sponsor: Wolfson Medical Center
• Public title: Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis MUPPIT
• Scientific title: Multi Center Ulcerative Colitis Pediatric Pentasa Intervention Trial (MUPPIT). A Randomized, Single-blinded, Controlled, Parallel, Induction Therapy With Once vs. Twice Daily Dosing of Pentasa in Pediatric UC.
• Date of first enrolment: September 2010
• Target sample size: 86
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01201122
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Israel

Contacts

• Name: Batia Weiss, MD
• Affiliation: Safra Children`s Hospital, Sheba MC, Tel-Hashomer, Israel

• Name: Ron Shaoul, MD
• Affiliation: Pediatric Gastroenterology Unit, Meyer Children's Hospital, Rambam MC, Haifa, Israel

• Name: Arie Levine, MD
• Affiliation: Pediatric Gastroenterology and Nutrition Unit, The E. Wolfsom MC, Tel-Aviv Universiy, Holon, Israel

• Name: Dan Turner, MD, PhD
• Affiliation: Pediatric Gastroenterology and Nutrition Unit, The Hebrew Universitiy of Jerusalem, Shaare Zedek MC, Jerusalem, Israel

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Children 6-18 years of age, weight least 15kg.

2. Diagnosis of UC, established by the presence of accepted clinical, radiologic,
endoscopic and histologic criteria.

3. Mild to moderate disease activity at the time of enrolment as judged by the Pediatric
UC Activity Index (PUCAI) score 10-55 points.

4. In general good health (other than the diagnosis of UC), based on medical history,
physical examination, and screening laboratory results.

5. Infectious colitis excluded by stool cultures, ova and parasite examination and
Clostridium difficile assay.

6. 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 Criteria:

1. Weight <15 kg at enrolment

2. Patients whose disease is confined to the rectum (i.e. proctitis).

3. Fever >38.5 degrees.

4. Patients with Crohn's colitis or with IBD type unclassified (IBD-U) according to
Montreal classification.

5. 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.

6. Exacerbation associated with infectious organism in the stool.

7. Current treatment with steroids (any dose) or the need for steroid therapy as judged
by the responsible gastroenterologist.

8. 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.

9. 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.

10. Treatment with biologic therapy including, but not limited to: infliximab,
certolizumab, adalimumab within 90 days prior to screening visit.

11. 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.

12. Known allergy to 5ASA, salicylates, or aminosalicylates.

13. 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.

14. 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).

15. History of recurrent pancreatitis.

16. 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.



Age minimum: 6 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Mild to Moderate Ulcerative Colitis

Intervention(s)

Drug: Mesalamine

Primary Outcome(s)

Difference in mean PUCAI score between the groups. [Time Frame: At week 6 after initiation of therapy.]

Secondary Outcome(s)

Treatment success defined as Complete response OR large partial response. [Time Frame: At 3 and 6 weeks from initiation of therapy.]

Secondary ID(s)

0052-10-WOMC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors