Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00705978
• Date of registration: 26/06/2008
• Prospective Registration: No
• Primary sponsor: Abbott Products
• Public title: Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis
• Scientific 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
• Date of first enrolment: June 2008
• Target sample size: 62
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00705978
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Guenter Krause, MD
• Affiliation: Abbott Products

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pancreatic Insufficiency

Intervention(s)

Drug: Pancreatin

Drug: Placebo

Primary Outcome(s)

Change in CFA from baseline to the end of double blind treatment [Time Frame: 7 days after baseline]

Secondary Outcome(s)

CNA, stool fat, stool weight, nutritional, clinical symptomatology, SF-36, BMI [Time Frame: 7 days after baseline, and end of open-label period (1 year of open label treatment)]

Secondary ID(s)

S245.4.009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Quintiles, Datamap