PR-018: An Open-Label, Safety Extension of Study PR-011
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01131507|
Recruitment Status : Completed
First Posted : May 27, 2010
Results First Posted : March 7, 2014
Last Update Posted : March 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Exocrine Pancreatic Insufficiency||Drug: EUR-1008 (APT-1008)||Phase 4|
This is a multi-center, open-label, safety extension of Aptalis (formerly Eurand) study PR-011 (NCT01100606) in pediatric participants with EPI due to CF. The study will be carried out in participants who completed the PR-011 study.
The study is comprised of 5 visits: an enrollment visit, treatment visit 1 (3 months), treatment visit 2 (6 months), treatment visit 3 (9 months) and treatment visit 4 (12 months). Once determined eligible for participation, participants will be enrolled into the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-Label, Safety Extension of Study PR-011 Titled: 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)|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
|Experimental: EUR-1008 (APT-1008)||
Drug: EUR-1008 (APT-1008)
EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose will be adjusted based on participants' age and body weight. Total dose will not exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment will be up to 12 months.
Other Name: Zenpep® (pancrelipase) 3,000 lipase units delayed release capsules
- Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to Month 12 or early termination ]TEAE was any event not present prior to exposure to study drug or any event already present that worsened in either intensity or frequency following exposure to test drug. Serious AE (SAE) was any event that resulted in death, immediately life threatening, hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Number of participants with TEAEs, SAEs, TEAE's relationship to study drug (unrelated, possible and probable) and on the basis of severity (mild [minimal/no treatment and did not interfere with daily activities], moderate [resulted in a low level of inconvenience or concern with the therapeutic measures and may have caused some interference with functioning] and severe [interrupted participant's usual daily activity, may have required systemic drug therapy or other treatment and were usually incapacitating]) with a frequency threshold of above 5% were reported.
- Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12 [ Time Frame: Baseline, Month 3, 6, 9 and 12 ]Participant's ability to thrive was evaluated through growth percentiles for weight-for-age, length-for-age and weight-for-length recorded on Center for Disease Control and Prevention (CDC) growth charts during each treatment visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01131507
|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|
|Study Director:||Aptalis Medical Information||Forest Laboratories|