Status:
COMPLETED
Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis
Lead Sponsor:
Abbott Products
Collaborating Sponsors:
Datamap
Conditions:
Pancreatic Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will provide efficacy data for Creon 40,000 in CP subjects as well as long-term safety data. During the long-term treatment with Creon 40,000 nutritional parameters will be assessed and cor...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Pancreatic exocrine insufficiency has to be proven (in medical history) by a pancreatic function test
- Chronic pancreatitis has to be proven (in medical history) by CT, ERCP, plain film with pancreatic calcifications, ultrasonography (calcifications,duct dilatation) and /or histology
- Females must be non-lactating and either be of non-childbearing potential or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to Visit 1 (Day -14).
- Subjects with a pathological stool fat during run in period (\> 10g/24 h)
- Exclusion Criteria
- Ileus or acute abdomen
- Any type of malignancy involving the digestive tract in the last 5 years
- Presence of pseudo pancreatic cysts \>= 4 cm
- Current excessive intake of alcohol or drug abuse
- Hypersensitivity vs porcine proteins / pancreatin
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00705978
Start Date
June 1 2008
End Date
May 1 2010
Last Update
August 18 2011
Active Locations (11)
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1
Site Reference ID/Investigator# 45389
Bangalore, India, 560017
2
Site Reference ID/Investigator# 45396
Bhopal, India, 462 016
3
Site Reference ID/Investigator# 45390
Chennai, India, 600096
4
Site Reference ID/Investigator# 45391
Hyderabad, India, 500082