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

Abbott

Status and phase

Completed

Phase 3

Conditions

Pancreatic Insufficiency

Treatments

Drug: Pancreatin

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00705978

S245.4.009

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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