Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
An Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
1 other identifier
interventional
19
1 country
12
Brief Summary
This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2009
Shorter than P25 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2008
CompletedFirst Posted
Study publicly available on registry
October 20, 2008
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedResults Posted
Study results publicly available
October 1, 2010
CompletedNovember 8, 2010
October 1, 2010
2 months
October 17, 2008
September 9, 2010
October 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)
Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake.
10 Days
Secondary Outcomes (3)
Stool Fat (% Fat)
Last 3 days in a 10-day treatment period
Fat Intake (g)
Last 3 days in a 10-day treatment period
Total Calorie Intake (kcal)
Last 3 days in a 10-day treatment period
Study Arms (1)
A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene analysis
- Current or historical human fecal elastase \< 50µg/gstool
- Weight greater than 3.75 kg
- Age 1 month to 6 years
- Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
- Clinically stable condition without evidence of acute respiratory disease or any other acute condition
You may not qualify if:
- Ileus or acute abdomen
- History of fibrosing colonopathy, Celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome
- History of distal ileal obstruction syndrome within 6 months of enrollment
- Use of an immunosuppressive drug
- Any type of malignancy involving the digestive tract in the last 5 years
- Known infection with HIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Site 11
Boise, Idaho, United States
Site 5
Louisville, Kentucky, United States
Site 9
Boston, Massachusetts, United States
Site 6
Ann Arbor, Michigan, United States
Site 12
Detroit, Michigan, United States
Site 4
Minneapolis, Minnesota, United States
Site 13
Long Branch, New Jersey, United States
Site 8
Albuquerque, New Mexico, United States
Site 1
Cincinnati, Ohio, United States
Site 10
Oklahoma City, Oklahoma, United States
Site 7
Oklahoma City, Oklahoma, United States
Site 3
Hershey, Pennsylvania, United States
Related Publications (1)
Graff GR, McNamara J, Royall J, Caras S, Forssmann K. Safety and tolerability of a new formulation of pancrelipase delayed-release capsules (CREON) in children under seven years of age with exocrine pancreatic insufficiency due to cystic fibrosis: an open-label, multicentre, single-treatment-arm study. Clin Drug Investig. 2010;30(6):351-64. doi: 10.2165/11533390-000000000-00000.
PMID: 20441244BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sven Voet - Global Communication
- Organization
- Solvay Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Global Clinical Director Solvay
Solvay Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 17, 2008
First Posted
October 20, 2008
Study Start
April 1, 2009
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
November 8, 2010
Results First Posted
October 1, 2010
Record last verified: 2010-10