Clinical Trial: Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects With
Brief Summary: The objective of this study is to assess the efficacy and safety of different doses of Creon Immediate Release (IR) in comparison to Creon® 25,000 Delayed Release/Gastro-Resistant (DR/GR) in subjects with Pancreatic Exocrine Insufficiency (PEI) due to Cystis Fibrosis (CF).
Detailed Summary:
This study is a Phase II, randomized, parallel-group, active-controlled, double-blind, dose ranging, multicenter study with 4 different doses of Creon IR and one dose of the active control Creon® (DR/GR), administered in subjects of 12 years or older with PEI due to CF.
The study is divided into two periods: a screening period of 14 days and a double-blind treatment period of 6 to 7 days.
Sponsor: Abbott
Current Primary Outcome: Coefficient of Fat Absorption (CFA) [ Time Frame: End of the 6 to 7 days double-blind treatment period ]
Original Primary Outcome: Coefficient of Fat Absorption (CFA) [ Time Frame: End of the 6 to 7 days double-blind treatment period ]
Current Secondary Outcome:
- Coefficient of Nitrogen Absorption (CNA) [ Time Frame: End of the 6 to 7 days double-blind treatment period ]CNA is calculated from nitrogen intake and nitrogen excretion, according to the formula: CNA (%) = 100 [nitrogen intake - nitrogen excretion] / nitrogen intake)
- Stool Fat Content [ Time Frame: End of the 6 to 7 days double-blind treatment period ]Total amount of fat excreted during the stool collection period in grams.
- Stool Weight [ Time Frame: End of the 6 to 7 days double-blind treatment period ]Total amount of stool weight during the collection period in grams
Original Secondary Outcome:
- Coefficient of Nitrogen Absorption (CNA) [ Time Frame: End of the 6 to 7 days double-blind treatment period ]Comparison and modeling of protein digestion (measured by CNA) following treatment with four different doses of Creon IR and Creon® (DR/GR)
- Stool Fat Content [ Time Frame: End of the 6 to 7 days double-blind treatment period ]Comparison of stool fat content following treatment with four different doses of Creon IR and Creon® (DR/GR)
- Stool Weight [ Time Frame: End of the 6 to 7 days double-blind treatment period ]Comparison of stool weight following treatment with four different doses of Creon IR and Creon® (DR/GR)
- Hematology & Biochemistry blood values as a measure of safety [ Time Frame: End of the 6 to 7 days double blind treatment period ]Safety laboratory values including changes from baseline, will be summarized per treatment group
- Physical examination [ Time Frame: End of the 6 to 7 days double blind treatment period ]Vital signs including changes from baseline, will be summarized per treatment group
- Clinical symptomatology [ Time Frame: End of the 6 to 7 days double blind treatment period ]Stool frequency, stool consistency, abdominal pain and flatulence will be summarized per treatment group
- Adverse events [ Time Frame: 5 to 7 days post DB treatment period ]Treatment emergent adverse events will be summarized per treatment group
Information By: Abbott
Dates:
Date Received: March 19, 2015
Date Started: March 2015
Date Completion:
Last Updated: March 7, 2016
Last Verified: March 2016