Clinical Trial: Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine P
Brief Summary: The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older.
Detailed Summary:
Sponsor: Forest Laboratories
Current Primary Outcome: Coefficient of Fat Absorption over 72 hours (CFA-72h) [ Time Frame: 72 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Body weight [ Time Frame: 58 days. ]Body weight at baseline (Visit 2 [Day 0]) and at the end of each treatment period.
- Coefficient of nitrogen absorption [ Time Frame: 72 hours ]Coefficient of nitrogen absorption at the end of each treatment period as assessed by a specialised central laboratory by means of Dumas combustion method.
- Control of signs and symptoms of EPI [ Time Frame: 2- 14 day periods ]
Control of signs and symptoms of EPI (as recorded in subject diaries). The following will be captured:
- Stools frequency (number/day)
- Stools consistency (hard, formed/normal; soft, watery, overt diarrhoea)
- Fat or grease visible in stools (Yes/No)
- Abdominal pain (mild, moderate, severe)
- Bloating (mild, moderate, severe)
- Flatulence (mild, moderate, severe)
- Impact on overall health, daily life, perceived well-being, and symptoms [ Time Frame: 58 days ]Impact on overall health, daily life, perceived well-being, and symptoms evaluated using the CFQ (administered by designated study personnel prior to randomisation and at the end of each treatment period).
- Total cholesterol, calculated LDL-C, HDL-C [ Time Frame: 58 days ]Total cholesterol, calculated LDL-C, HDL-C (sampling performed prior to randomisation and at the end of each treatment period).
- Treatment Emergent Adverse Events [ Time Frame: 78 days ]Frequency, duration, and severity of treatment-emergent adverse events (TEAEs);
- Standard safety laboratory tests [ Time Frame: 58 days ]
Standard safety laboratory tests, analysed by central laboratory:
- Haematology: red blood cell count, haemoglobin, haematocrit, total leukocytes with diff count, and platelets
- Serum biochemistry: alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total protein, albumin, total bilirubin, direct and indirect bilirubin, blood urea nitrogen, uric acid, creatinine, fasting plasma glucose, fasting cholesterol evaluations (total cholesterol, LDL-C, HDL-C, and triglycerides), fat-soluble vitamins (A, D, and E) and serum electrolytes
- Vital signs [ Time Frame: 78 days ]Vital signs including blood pressure, heart rate, respirations and body temperature.
- Fat-soluble vitamins A, D, and E [ Time Frame: 58 days ]Fat-soluble vitamins A, D, and E (sampling performed prior to randomisation and at the end of each treatment period).
Original Secondary Outcome: Same as current
Information By: Forest Laboratories
Dates:
Date Received: July 10, 2012
Date Started: June 2012
Date Completion:
Last Updated: March 13, 2014
Last Verified: March 2014