Clinical trial NCT00705978: Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis
Official title: A One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Insufficiency
Keywords: Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Datamap
First posted: 2008-06-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 correlated with CFA.


Eligibility criteria: 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

Primary outcomes:
measure: Change in CFA from baseline to the end of double blind treatment
timeFrame: 7 days after baseline
Secondary outcomes:
measure: CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI
timeFrame: 7 days after baseline, and end of open-label period (1 year of open label treatment)
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Site Reference ID/Investigator# 45389
city: Bhopal
country: India
facility: Site Reference ID/Investigator# 45396
city: Chennai
country: India
facility: Site Reference ID/Investigator# 45390
city: Cochin
country: India
facility: Site Reference ID/Investigator# 54382
city: Hyderabad
country: India
facility: Site Reference ID/Investigator# 45391
city: Jaipur
country: India
facility: Site Reference ID/Investigator# 45388
city: Kolkatta
country: India
facility: Site Reference ID/Investigator# 45387
city: Mumbai
country: India
facility: Site Reference ID/Investigator# 45383
city: Pune
country: India
facility: Site Reference ID/Investigator# 45382
city: Pune
country: India
facility: Site Reference ID/Investigator# 45395
city: Trivandrum
country: India
facility: Site Reference ID/Investigator# 45393
Study officials:
affiliation: Abbott Products
name: Guenter Krause, MD
role: STUDY_DIRECTOR
References: