A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2009
Links EUCTR - PL
INTERVENTION: Trade Name: Asacol Product Name: Asacol Product Code: NA Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: MESALAZINE CAS Number: 89576 Concentration unit: g gram(s) Concentration type: equal Concentration number: 0.4‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Mildly‐to‐Moderately Active Ulcerative Colitis in Children and Adolescents ; MedDRA version: 11.0 Level: LLT Classification code 10045365 Term: PRIMARY OUTCOME: Main Objective: The overall objective of this study is to assess the safety and efficacy of high dose and low dose Asacol administered as 400 mg delayed‐release tablets given every 12 hours for 6 weeks to children and adolescents with mildly‐to‐moderately active ulcerative colitis.; The primary efficacy objective is to assess the proportion of patients that achieve treatment success using the validated Pediatric Ulcerative Colitis Activity Index (PUCAI). Primary end point(s): The primary efficacy endpoint is the proportion of patients that achieve PUCAI‐TS Secondary Objective: The secondary efficacy objectives are to assess the following:; • PUCAI Complete Response;; • PUCAI Partial Response;; • PUCAI Treatment Failure;; • Truncated Mayo Treatment Success;; • Truncated Mayo Complete Response;; • Truncated Mayo Partial Response;; • Truncated Mayo Treatment Failure.; To assess biomarker resolution in Asacol treated pediatric patients with mildly‐to‐moderately active UC, secondary objectives will include assessment of biomarker endpoints as follows:; • the proportion of patients who show reduction from Baseline in the fecal and serum; lactoferrin and calprotectin biomarkers;; • the proportion of patients who achieve a specified cutoff level in fecal lactoferrin and calprotectin biomarkers;; • the change in lactoferrin and calprotectin biomarkers from Baseline to Week 6. INCLUSION CRITERIA: Patients are eligible to participate in the study if they: a. are male or female between the ages of 5 and 17 years, inclusive, at the time of the first dose of study medication, with a history of biopsy and endoscopy confirmed UC; b. have mildly‐to‐moderately active UC (either newly diagnosed or that has relapsed) as defined clinically by a Pediatric UC Activity Index (PUCAI) score = 10 and = 55, and, in the opinion of the Investigator, the patient does not require steroids c. have baseline scores of at least 1 for both rectal bleeding (Streaks of blood with stool less than half of the time) and stool frequency (1‐2 stools greater than normal per day) as defined by the TM‐Mayo Score d. are generally in good health (other than the diagnosis of UC), based on medical history, physical examination, and screening laboratory results; e. are able to swallow Asacol tablets (400 mg marketed US formulation); f. have a body weight no less than 17 kg an
Epistemonikos ID: aa4f8ed17b5aae245e0868125e10a2f8e7d450a8
First added on: Mar 23, 2022