Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
2 other identifiers
interventional
35
5 countries
23
Brief Summary
This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with 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 Nov 2007
Shorter than P25 for phase_3
23 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
August 1, 2007
CompletedFirst Posted
Study publicly available on registry
August 2, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
July 20, 2009
CompletedJune 3, 2010
August 1, 2009
4 months
August 1, 2007
May 29, 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 (6)
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
- +1 more secondary outcomes
Other Outcomes (1)
Percentage of Days With Formed/Normal Stools.
5 days
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 CFA \< 70% without supplementation or current or historical fecal elastase \< 50µg/g stool (within the last 12 months)
- Subjects of 12 years or older
- 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
- Females of child-bearing potential must agree to continue using a medically acceptable method of birth control
You may not qualify if:
- Ileus or acute abdomen
- History of fibrosing colonopathy
- 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 (23)
Site 11
Long Beach, California, United States
Site 10
Los Angeles, California, United States
Site 13
San Francisco, California, United States
Site 5
Miami, Florida, United States
Site 4
Orlando, Florida, United States
Site 1
Iowa City, Iowa, United States
Site 7
Louisville, Kentucky, United States
Site 17
Boston, Massachusetts, United States
Site 8
Ann Arbor, Michigan, United States
Site 6
Minneapolis, Minnesota, United States
Site 18
Long Branch, New Jersey, United States
Site 16
Albuquerque, New Mexico, United States
Site 19
Cincinnati, Ohio, United States
Site 12
Dayton, Ohio, United States
Site 2
Toledo, Ohio, United States
Site 14
Oklahoma City, Oklahoma, United States
Site 3
Hershey, Pennsylvania, United States
Site 15
Philadelphia, Pennsylvania, United States
Site 9
Nashville, Tennessee, United States
Site 20
Petrofi, Hungary
Site 21
Jerusalem, Israel
Site 22
Johannesburg, South Africa
Site 23
Barcelona, Spain
Related Publications (1)
Trapnell BC, Maguiness K, Graff GR, Boyd D, Beckmann K, Caras S. Efficacy and safety of Creon 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2009 Dec;8(6):370-7. doi: 10.1016/j.jcf.2009.08.008. Epub 2009 Oct 7.
PMID: 19815466RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Only treatment emergent events have been presented. They are defined as events started at or after the 1st administration of study medication and include events started prior to the 1st administration but which worsened after the 1st intake.
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
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 1, 2007
First Posted
August 2, 2007
Study Start
November 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
June 3, 2010
Results First Posted
July 20, 2009
Record last verified: 2009-08