Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT00535756
Eligibility Criteria:
Inclusion Criteria
Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:
* Direct or indirect pancreatic function test (except stool fat excretion) and
* Steatorrhoea: stool fat \> 15 g/day (using van de Kamer method)
* Proven chronic pancreatitis
* Females of child-bearing potential must agree to continue using a medically acceptable method of birth control
Exclusion Criteria
* Subjects in an unstable situation (catabolic) after pancreatic surgery
* Ileus or acute abdomen
* Current excessive intake of alcohol or drug abuse
* Hypersensitivity vs porcine proteins / pancreatin
* Subjects taking digestive enzyme preparations have to stop them before start of the run-in period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00535756
Study Brief:
Protocol Section:
NCT00535756