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A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

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Trial Profile

A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Pancrelipase (Primary)
  • Indications Cystic fibrosis; Exocrine pancreatic insufficiency
  • Focus Therapeutic Use
  • Sponsors Abbott Healthcare Products

Most Recent Events

  • 13 Mar 2018 New trial record
  • 01 Dec 2011 Results of prospective data analysis investigating sparse stool sample collection as an alternative to complete 72-hour collection for measurement of stool fat in subjects with EPI published in the Journal of Pediatric Gastroenterology and Nutrition

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