Who is sponsoring NCT00981214?

NCT00981214 is sponsored by Forest Laboratories.

What condition does NCT00981214 study?

NCT00981214 studies Cystic Fibrosis, Exocrine Pancreatic Insufficiency.

What drugs are being tested in NCT00981214?

Interventions: EUR-1008 (APT-1008).

What is the status of NCT00981214?

NCT00981214 is currently COMPLETED.

Last reviewed 2017-02-08 · How we verify

An Open-Label Study to Evaluate the Efficacy and Safety of Pancreatic Enzyme Product (PEP) Microtabs in Pediatric Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency

NCT00981214 Phase 3 COMPLETED Results posted

This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).

Details

Lead sponsor	Forest Laboratories
Phase	Phase 3
Status	COMPLETED
Enrolment	19
Start date	2006-05
Completion	2006-09

Conditions

Cystic Fibrosis
Exocrine Pancreatic Insufficiency

Interventions

EUR-1008 (APT-1008)

Primary outcomes

Percentage of Participants Who Were Responders After 1 Week of Treatment With Study Medication — Day 11
Responders were defined as those participants without steatorrhea (defined as less than 30 percent (%) fecal fat content) and without signs and symptoms of malabsorption after 1 week of treatment with study medication.
Percentage of Participants Who Were Responders After 2 Weeks of Treatment With Study Medication — Day 18 (end of treatment)
Responders were defined as those participants without steatorrhea (defined as less than 30% fecal fat content) and without signs and symptoms of malabsorption after 2 weeks of treatment with study medication.

Countries

United States