CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 107 enrolled
Drug / intervention
MMX Mesalamine/Mesalazine (Low Dose) +1 moredrug
Likely dose
MMX Mesalamine/Mesalazine (Low Dose) 900 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02093663
NCT02093663Phase 3Completed
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A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance Phases

Shire·interventional·Posted Mar 21, 2014·Updated Jun 9, 2021

In Brief

A Phase 3 clinical trial evaluating MMX Mesalamine/Mesalazine (Low Dose) and MMX Mesalamine/Mesalazine (High Dose) for Ulcerative Colitis. Completed, enrolled 107 participants across 33 sites in 7 countries.

Detailed Summary

To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesCanada, Hungary, Israel, Poland, Slovakia, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 21, 2014
Enrollment StartDec 12, 2014
Primary CompletionNov 28, 2018
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 12.3 years ago

Interventions

MMX Mesalamine/Mesalazine (Low Dose)drug

Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (\<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (\>) 23 kg to \<= 35 kg; 1800 mg/day for participants weighing \> 35 kg to \<= 50 kg; 2400 mg/day for participants weighing \> 50 kg to \<= 90 kg.

MMX Mesalamine/Mesalazine (High Dose)drug

Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to \<= 23 kg; 2400 mg/day for participants weighing \> 23 kg to \<= 35 kg; 3600 mg/day for participants weighing \> 35 kg to \<= 50 kg; 4800 mg/day for participants weighing \> 50 kg to \<= 90 kg.