Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
1 other identifier
interventional
17
1 country
10
Brief Summary
This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency 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 Jun 2008
Shorter than P25 for phase_3
10 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
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 3, 2008
CompletedFirst Posted
Study publicly available on registry
June 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
March 10, 2010
CompletedJune 2, 2010
February 1, 2010
6 months
June 3, 2008
November 30, 2009
May 26, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Coefficient of Fat Absorption (%)
This coefficient is calculated from fat intake and fat excretion : 100\*\[fat intake-fat excretion\]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.
5 days
Secondary Outcomes (7)
Coefficient of Nitrogen Absorption (%)
5 days
Total Fat Excretion (Grams)
5 days
Total Stool Weight (Grams)
5 days
Stool Frequency
5 days
Percentage of Days With no Flatulence.
5 days
- +2 more secondary outcomes
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
- Confirmed PEI by historical Coefficient of fat Absorption \< 70% without supplementation or current or historical fecal elastase \< 50µg/stool (within the last 12 months)
- 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
- Stable body weight and agrees to abstain from sexual activity
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 (10)
Site 2
Iowa City, Iowa, United States
Site 5
Louisville, Kentucky, United States
Site 9
Boston, Massachusetts, United States
Site 6
Ann Arbor, Michigan, United States
Site 4
Minneapolis, Minnesota, 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 (2)
Graff GR, Maguiness K, McNamara J, Morton R, Boyd D, Beckmann K, Bennett D. Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. Clin Ther. 2010 Jan;32(1):89-103. doi: 10.1016/j.clinthera.2010.01.012.
PMID: 20171415RESULTCaras S, Boyd D, Zipfel L, Sander-Struckmeier S. Evaluation of stool collections to measure efficacy of PERT in subjects with exocrine pancreatic insufficiency. J Pediatr Gastroenterol Nutr. 2011 Dec;53(6):634-40. doi: 10.1097/MPG.0b013e3182281c38.
PMID: 21681115DERIVED
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
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 3, 2008
First Posted
June 5, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
June 2, 2010
Results First Posted
March 10, 2010
Record last verified: 2010-02