Clinical Trial: Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency
Brief Summary: The purpose of this study is to determine the most effective dose of a new enzyme therapy on oral nutrient absorption in cystic fibrosis (CF) subjects with exocrine pancreatic insufficiency.
Detailed Summary:
Sponsor: Anthera Pharmaceuticals
Current Primary Outcome: Change from baseline up to 19 days in Coefficient of fat absorption (CFA) [ Time Frame: Baseline, up to 19 days ]
Original Primary Outcome: Coefficient of fat absorption (CFA)
Current Secondary Outcome:
- Change from baseline up to 19 day in Coefficient of nitrogen absorption (CNA) [ Time Frame: Baseline, up to 19 days ]
- Change from baseline up to 19 days in stool weight [ Time Frame: Baseline, up to 19 days ]
- Change from baseline to 29 day endpoint in Cystic Fibrosis Questionnaire (CFQ) scale scores [ Time Frame: Baseline, 29 days ]
- Change from baseline up to 19 days in number of Stools [ Time Frame: Baseline, up to 19 days ]
- Change from baseline to 28 days in maximum change in glucose response [ Time Frame: Baseline through 28 days ]
Original Secondary Outcome:
- Coefficient of nitrogen absorption (CNA)
- Weight of stools
- Number of stools
- Starch digestion and carbohydrate absorption as measured by blood glucose response
- Quality of life as measured by the Cystic Fibrosis Questionnaire (CFQ)
Information By: Anthera Pharmaceuticals
Dates:
Date Received: November 9, 2004
Date Started: June 2004
Date Completion:
Last Updated: October 15, 2014
Last Verified: October 2014
