Status:
COMPLETED
A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Chronic Pancreatitis
Pancreatectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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-...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00414908
Start Date
October 1 2007
End Date
December 1 2009
Last Update
August 10 2011
Active Locations (30)
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1
Site 9
Scottsdale, Arizona, United States
2
Site 22
Bristol, Connecticut, United States
3
Site 7
Tampa, Florida, United States
4
Site 6
Atlanta, Georgia, United States