Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis

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.

Timeline

Start

2014-12-12

Primary completion

2018-11-28

Completion

2018-11-28

Outcome

Mixed primary results

paper In the DBA phase, the high-dose group (n = 17; 65.4%) achieved a higher clinical response rate than the low-dose (n = 10; 37.0%) group; PMID 37855022 ↗

paper difference 28.3% (95% CI: 2.5-54.2; p = 0.039), odds ratio (OR) 3.21 (95% CI: 1.04-9.88). PMID 37855022 ↗

paper similar proportions of patients maintained clinical response in the low-dose (n = 23; 54.8%) and high-dose (n = 24; 53.3%) groups: OR 0.99 (0.42-2.34); p = 0.981. PMID 37855022 ↗

Publications

• Croft NM, Korczowski B, Kierkus J, Caballero B, Thakur MK. Safety and efficacy of multimatrix mesalamine in paediatric patients with mild-to-moderate ulcerative colitis: a phase 3, randomised, double-blind study. EClinicalMedicine. 2023 Oct 6;65:102232. doi: 10.1016/j.eclinm.2023.102232. eCollection 2023 Nov.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mesalamine	Small molecule	900 mg	Oral
Subject	Mesalamine	Small molecule	1200 mg	Oral
Subject	Mesalamine	Small molecule	1800 mg	Oral
Subject	Mesalamine	Small molecule	2400 mg	Oral
Subject	Mesalamine	Small molecule	3600 mg	Oral
Subject	Mesalamine	Small molecule	4800 mg	Oral

Indications