NCT03450772

Equivalence Study to Compare Two Strengths of Creon in China

Open-label, Multicenter, Randomized, Cross-Over, Equivalence Study to Compare the Efficacy and Safety of Two Strengths of Pancreatin Enteric-Coated Capsules in Pancreatic Exocrine Insufficiency in Chinese Subjects

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60 subjects for Pancreatin Enteric-Coated Capsules 10000. The study will be conducted in up to 10 sites in China.

Conditions

• Pancreatic Insufficiency

Interventions

Type	Name	Description
DRUG	Creon® 25000	Experimental drug
DRUG	Creon® 10000	Active comparator

Timeline

• Start date: 2017-08-31
• Primary completion: 2022-04-01
• Completion: 2022-04-30
• First posted: 2018-03-01
• Last updated: 2021-11-24

Locations

1 site across 1 country: China