NCT01327703

Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

An Open-label, Multicenter, Randomized, Cross-over Study to Compare the Safety and Efficacy of PANZYTRAT® 25,000 to KREON® 25,000 in the Control of Steatorrhea in Subjects Aged 7 Years and Older With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).

Detailed description

This is an open-label, Phase IV, multicenter, randomized, two-period cross-over study to compare the efficacy and safety of Panzytrat® 25,000 to Kreon® 25,000 in participants aged 7 years and older suffering from CF and EPI. The study consists of a qualification phase (5 to 15 days); two treatment periods of 14 days each (plus a 3-day window if needed) and a 3-day stool collection will be performed from Days 12 to 15. A safety follow-up phone call will be arranged 7-10 days after completion of the treatment phase or after an early discontinuation.

Conditions

• Exocrine Pancreatic Insufficiency
• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Panzytrat® 25,000	Panzytrat® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day in either first treatment period or second treatment period.
DRUG	Kreon® 25,000	Kreon® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 Ph.Eur. units lipase/kg body weight/day in either first treatment period or second treatment period.

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-04-04
• Last updated: 2014-04-10
• Results posted: 2014-04-10

Locations

13 sites across 2 countries: Germany, Poland