A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
2 other identifiers
interventional
52
8 countries
30
Brief Summary
This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.
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 Oct 2007
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2006
CompletedFirst Posted
Study publicly available on registry
December 22, 2006
CompletedStudy Start
First participant enrolled
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedResults Posted
Study results publicly available
September 16, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedAugust 10, 2011
August 1, 2011
10 months
December 21, 2006
August 7, 2009
August 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.
The CFA is calculated from fat intake and fat excretion : 100\*\[fat intake-fat excretion\]/fat intake. Higher values indicated a better response. Change is calculated as (DB CFA-Baseline CFA).
End of double-blind period (5-7 days)
Secondary Outcomes (7)
Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.
End of double-blind period (5-7 days)
Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.
End of double-blind period (5-7 days)
Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.
End of double-period (5-7 days)
Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period
End of double-period (5-7 days)
Abdominal Pain at the End of the Double-blind Period.
End of double-period (5-7 days)
- +2 more secondary outcomes
Other Outcomes (1)
Change of Stool Frequency Between "Original" Baseline and End of Open-label Period (OL)
27 weeks
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:
- Direct or indirect pancreatic function test (except stool fat excretion) or Clinical signs of severe steatorrhoea that resolved upon administration of pancreatic supplementation.
- Total stool fat \> 40 g over 4 days (using Van De Kamer method)
- Proven chronic pancreatitis
- 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
- Any type of malignancy involving the digestive tract in the last 5 years
- Presence of pseudo-pancreatic cyst ≥ 4
- Continued excessive intake of alcohol or drug abuse
- Known infection with HIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Site 9
Scottsdale, Arizona, United States
Site 22
Bristol, Connecticut, United States
Site 7
Tampa, Florida, United States
Site 6
Atlanta, Georgia, United States
Site 17
Chicago, Illinois, United States
Site 30
Maywood, Illinois, United States
Site 14
Indianapolis, Indiana, United States
Site 15
Kansas City, Kansas, United States
Site 16
Lexington, Kentucky, United States
Site 12
New Orleans, Louisiana, United States
Site 3
Boston, Massachusetts, United States
Site 2
Ann Arbor, Michigan, United States
Site 29
Grand Rapids, Michigan, United States
Site 1
Tupelo, Mississippi, United States
Site 5
St Louis, Missouri, United States
Site 8
Cedar Knolls, New Jersey, United States
Site 20
Boone, North Carolina, United States
Site 4
Rutherford College, North Carolina, United States
Site 10
Cincinnati, Ohio, United States
Site 11
Cleveland, Ohio, United States
Site 21
Pittsburgh, Pennsylvania, United States
Site 13
Dallas, Texas, United States
Site 18
Richmond, Virginia, United States
Site 23
Sofia, Bulgaria
Site 27
Warsaw, Poland
Site 19
San Juan, Puerto Rico
Site 25
Saint Petersburg, Russia
Site 26
Belgrade, Serbia
Site 24
Cape Town, South Africa
Site 28
Kiev, Ukraine
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 includes events started prior to the 1st administration but which worsened after the 1st intake.
Results Point of Contact
- Title
- Sven Voet - Global Communication
- Organization
- Abbott Products
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
December 21, 2006
First Posted
December 22, 2006
Study Start
October 1, 2007
Primary Completion
August 1, 2008
Study Completion
December 1, 2009
Last Updated
August 10, 2011
Results First Posted
September 16, 2009
Record last verified: 2011-08