Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

PHASE3CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

May 31, 2006

Primary Completion Date

November 30, 2006

Study Completion Date

November 30, 2006

Conditions
Cystic FibrosisExocrine Pancreatic Insufficiency
Interventions
DRUG

EUR-1008 (APT-1008)

EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.

DRUG

Placebo

Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.

DRUG

Placebo

Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.

DRUG

EUR-1008 (APT-1008)

EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.

Trial Locations (1)

75708

University of Texas Health Center at Tyler, Tyler

Sponsors
All Listed Sponsors
lead

Forest Laboratories

INDUSTRY