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

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

Indications