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 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT00744250
Eligibility Criteria:
Inclusion Criteria:
* Documented pancreatic enzyme insufficiency as determined by spot fecal elastase-1 (\<75 mcg/g) at the time of screening
* Required daily exogenous enzyme supplementation with commercially available pancreatic enzymes
* ≥ 18 years of age
* Male and female subjects
* Able to swallow capsules
* Clinically stable with no evidence of an acute medical conditions
Exclusion Criteria:
* History of fibrosing colonopathy in cystic fibrosis subjects
* Current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in the past 4 months
* Known contraindications, sensitivity or hypersensitivity to porcine pancreatic enzymes, benzocaine or similar products
* Women with a positive serum beta-hCG at the time of screening or the day of the study (due to radiation exposure)
* Liver disease
* ALT or AST ≥ 3 time the upper limit of normal
* Bilirubin ≥ 3 times the upper limit of normal
* Acute pancreatitis or acute exacerbation of chronic pancreatitis within 90 days
* Use of medications which affect with intestinal transit (example, narcotics, erythromycin, metoclopramide etc.)
* Subjects receiving treatment with antacids, H2 receptor blockers, or proton pump inhibitors and unable to discontinue these within 72 hr prior to the study day
* Diabetes mellitus
* A medical condition which the investigator deems significant enough to interfere with the ability of the subject to participate in the intubation study or interfere with the assessment of enzyme bioavailability
* Small bowel disease (i.e. celiac disease)
* Lactose intolerance
* History of gastric resection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00744250
Study Brief:
Protocol Section:
NCT00744250