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 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT01327703
Eligibility Criteria:
Inclusion Criteria:
* Participant or his/her legal representative signed informed consent form (ICF) prior to starting any study procedures
* Participant with clinical diagnosis of CF based on one or more typical clinical features of CF phenotype, in addition to one of the following: a genotype that documents the presence of 2 CF-causing mutation, or a sweat chloride test greater than or equal to 60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis on two separate occasions
* Participant with severe EPI confirmed by enzyme-linked immunosorbent assay (ELISA) measurement of fecal elastase-1 (FE-1)
* Male or female participant aged 7 years or older
* Participant currently receiving and has received a stable dose of lipase with either Panzytrat® 25,000 or Kreon® 25,000 for at least 30 days prior to ICF signature
* Participant generally in good health, except for the underlying symptoms associated with CF and EPI, and is clinically stable (no change in the last 30 days of physical examination) as evidenced by medical and medication histories, physical examination including vital signs during screening and laboratory tests
* Participant able to maintain a CF standardized diet with a lipid content customized to his/her needs during the study according to the qualification phase diary
* Women of childbearing potential must have a negative pregnancy test at study entry and must use a medically acceptable contraceptive method for the duration of the study
Exclusion Criteria:
* Participant with known contraindication, sensitivity or hypersensitivity to Panzytrat® 25,000 or Kreon® 25,000, or to any porcine protein
* Participant who recently received treatment of an emergent acute infection with oral or intravenous (IV) antibiotics that was not stopped at least 14 days prior to randomization
* Participant with chronic use of narcotics that were not stopped at least 7 days prior to the qualification visit
* Participant using of any prohibited medications or products listed in the prohibited medication section of the protocol
* Participant with acute pancreatitis or exacerbation of chronic pancreatic disease
* Participant with history of significant bowel resection that could impair fat absorption
* Participant with any condition known to increase fecal fat loss including but not limited to: celiac disease, Crohn's disease, tropical sprue, bacterial bowel infection, liver disease, lactose intolerance, pseudomembranous colitis, biliary and pancreatic cancer, radiation enteritis, Whipple's disease, Whipple's procedure, etc
* Participant with any significant gastrointestinal dysmotility disorders
* Participant with chronic abdominal pain or severe abdominal pain at study entry
* Participant using enteral tube feeding over day and night
* Participant with history or presence of clinically significant portal hypertension
* Participant with history or presence of complete distal intestinal obstruction syndrome (DIOS) in the past 6 months, or 2 or more episodes of DIOS in the past year
* Participant with poorly controlled diabetes as per the investigator's opinion
* Female participants who are pregnant or breastfeeding
* Participant with any condition or history of any illness, or pre-study laboratory abnormality which, in the opinion of the investigator or sponsor, might put the participant at risk, prevent the participant from completing the study, or otherwise affect the outcome of the study
* Participant using any investigational drug within 30 days prior to the date of signature of the ICF
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT01327703
Study Brief:
Protocol Section:
NCT01327703