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A Randomized, Double-blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis

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Trial Profile

A Randomized, Double-blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis

Status: Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 29 Aug 2025

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At a glance

  • Drugs Mesalazine (Primary)
  • Indications Ulcerative colitis
  • Focus Therapeutic Use
  • Sponsors AbbVie

Most Recent Events

  • 12 Aug 2025 Planned initiation date changed from 16 Sep 2024 to 15 Sep 2025.
  • 12 Aug 2025 Status changed from not yet recruiting to withdrawn prior to enrolment.
  • 27 Mar 2024 Planned End Date changed from 14 Sep 2024 to 19 Jul 2026.

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