A Study to Evaluate the Mode of Administration in Infants Less Than 12 Months of EUR-1008 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis	Device: Syringe nurser	Phase 4

Study Type:	Interventional
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)

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

Further study details as provided by Aptalis Pharma:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Enrollment:	15
Study Start Date:	May 2010
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Mode of Administration	Device: Syringe nurser Comparison of 2 different methods of administration

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	1 Month to 12 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of CF
Have the need for a PEP
Willing to switch subject from their previous PEP(if any) to ZENPEP®
Have a height to weight ratio target at greater than 10th percentile
Clinically stable

Exclusion Criteria:

Age <1 month and > 12 months
History of meconium ileus or small bowel atresia that required surgery
Allergic to pork or other porcines PEPs
Respiratory condition that required an intervention
Acute respiratory infection in the previous 14 days requiring antibiotics
Change in antacid dose in the 7 days before screening
Administration of oral, IM, IV glucocorticoids in the 4 weeks prior to screening
Any condition that would, in the investigator's opinion, limit the subject's ability to complete the study
Currently participating in or has participated in an investigational study, with the exception of observational studies, within 30 days of the screening visit.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100606

Locations

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

Sponsors and Collaborators

Aptalis Pharma

Investigators

Principal Investigator:

Jamie Wooldridge, MD

Children's Hospital Medical Center, Cincinnati

More Information

No publications provided

Responsible Party:	Manager of Clinical Development and Operations, Eurand Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT01100606 History of Changes
Other Study ID Numbers:	PR-011
Study First Received:	March 31, 2010
Last Updated:	July 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aptalis Pharma:

Exocrine Pancreatic Insufficiency
Infants with CF

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases

Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 17, 2012