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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00705978

Enrollment

Registered

2008-06-27

Start date

2008-06-30

Completion date

2010-05-31

Last updated

2011-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Insufficiency

Keywords

Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

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.

Interventions

DRUGPancreatin

Pancreatin with 40000 lipase units per capsule, 2 capsules per main meal (3 main meals) plus 1 capsule per snack (2-3 snacks)

DRUGPlacebo

placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in CFA from baseline to the end of double blind treatment	7 days after baseline

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026