An Open Label,Safety Extension of Eurand Study PR-011 (EUR-1008)
This study is ongoing, but not recruiting participants.
Sponsor:
Eurand Pharmaceuticals
Collaborator:
Aptalis Pharma
Information provided by:
Aptalis Pharma
ClinicalTrials.gov Identifier:
NCT01131507
First received: May 25, 2010
Last updated: July 13, 2011
Last verified: July 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
A Study to determine long term safety 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 |
Drug: EUR-1008 3,000 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Open-Label Safety Extension of PR-011: 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 (EPI) Associated With (CF) |
Resource links provided by NLM:
Genetics Home Reference related topics:
cystic fibrosis
MedlinePlus related topics:
Cystic Fibrosis
U.S. FDA Resources
Further study details as provided by Aptalis Pharma:
Primary Outcome Measures:
- Evaluate AEs during long term treatment [ Time Frame: up to 365 days ] [ Designated as safety issue: Yes ]Evaluate the frequency and severity of treatment-emergent AEs
Secondary Outcome Measures:
- Subjects ability to thrive [ Time Frame: Up to 365 days ] [ Designated as safety issue: Yes ]Evaluate the long term effects of EUR-1008
| Estimated Enrollment: | 12 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
EUR-1008 3,000
Long term safety
|
Drug: EUR-1008 3,000
capsule, taken as directed
|
Detailed Description:
Multi-center, Open-Label, Safety Extension of Eurand Study PR-011 in pediatric subjects with EPI associated with CF. The study will be carried out in infants greater than 1 month of age.
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, subjects will be enrolled into the study.
Eligibility| Ages Eligible for Study: | 1 Month to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Complete PR-011
Exclusion Criteria:
- Any condition that would, in the investigator's opinion, limit the subject's ability to complete the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131507
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
Eurand Pharmaceuticals
Aptalis Pharma
Investigators
| Study Chair: | Angelo Secci, MD | Aptalis Pharma |
More Information
No publications provided
| Responsible Party: | Candace Lee, Manager of Clinical Development and Operations, Eurand Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01131507 History of Changes |
| Other Study ID Numbers: | PR-018 |
| Study First Received: | May 25, 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 Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013