A Study to Evaluate the Mode of Administration in Infants Less Than 12 Months of EUR-1008
A Study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 3,000 lipase units capsules (the "EUR-1008"), a Pancreatic Enzyme Product ("PEP"), in infants with CF who need to take PEP medications to help break down the food that they eat.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)|
- Acceptability of Treatment Administration Method [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]Tolerability measured by the acceptability of the treatment administration method. Measurement based on completed questionnaires in which caregiver's rate the ease of treatment administration, time to complete treatment administration and overall satisfaction with treatment administration on a scale of 1 to 5.
- Effects of treatment on the oral mucosa [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]Safety assessed by the presence of lesions observed during a physical exams at each visit. Severity of lesions measured by investigator's assessment using the following scale: Mild = asymptomatic or mild symptoms; intervention not indicated; Moderate = moderate pain; not interfering with oral intake, modified diet indicated; Severe = severe pain, interfering with oral intake and life threatening or fatal.
- Changes in clinical laboratory results [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]Safety evaluated by treatment differences in results collected from standard of care laboratory assessments.
- Presence of the signs and symptoms of Exocrine Pancreatic Insufficiency (EPI) [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]Efficiacy mesured by the treatment differences in clinical signs and symptoms of Exocrine Pancreatic Insufficiency (EPI. This will be done based upon reported diary entries of signs and symptoms of EPI. Specifically measuring stool consistency(soft to hard), Presence of blood, oil or grease in the stool, and abdominal pain, bloating and gas measured on a scale of 0 to 3.
|Study Start Date:||May 2010|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Mode of Administration||
Device: Syringe nurser
Comparison of 2 different methods of administration
Multicenter, randomized, open-label, crossover study in pediatric subjects with EPI associated with CF. The study will be carried out in infants between 1 and 12 months of age.
The study is comprised of 1 screening period followed by 2 treatment periods and a follow-up visit. During the Screening Period, all subjects will be administered ZENPEP®. Once determined eligible for participation, subjects will be randomized to 1 of 2 treatment groups, and administered treatment with 1 of 2 different methods of administration.
|United States, Florida|
|Nemours Children's Clinic|
|Jacksonville, Florida, United States, 32250|
|United States, Nevada|
|Children's Lung Specialists Ltd.|
|Las Vegas, Nevada, United States, 89107|
|United States, Ohio|
|Akron Children's Hospital|
|Akron, Ohio, United States, 44308|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|United States, Texas|
|Cystic Fibrosis Care Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jamie Wooldridge, MD||Children's Hospital Medical Center, Cincinnati|