A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND

• Conditions: exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF); MedDRA version: 9.1Level: HLGTClassification code 10015674; MedDRA version: 9.1Level: LLTClassification code 10011762

• Registration Number: EUCTR2009-012842-21-IT
• Lead Sponsor: EURAND SPA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-23
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1.Definitive diagnosis of CF based on the following: o 1 clinical feature consistent with CF and o Either a genotype with 2 identifiable mutations known to cause CF or a sweat chloride concentration that is greater than 60 mEq/L by quantitative pilocarpine iontophoresis; 2.Pancreatic insufficiency documented by a monoclonal fecal elastase (FE) < 50 ?g/g stool at screening (test results within the previous 12 months are acceptable); 3.Currently receiving pancreatic enzyme treatment; 4.Adequate nutritional status based on the following: Body Mass Index (BMI) > 19 kg/m2 in adult subjects or a BMI percentile greater than or equal to the 10th percentile for age in adolescent subjects; 5.Are clinically stable with no evidence of concomitant illness or acute upper or lower respiratory tract infection during the 7- day interval prior to screening and preceding accession into this clinical study; 6.Willing to be switched from existing pancreatic enzyme treatment; 7.Female subject of childbearing potential must agree to maintain adequate birth control measures during the duration of the study; 8.Written informed consent obtained; 9.Appropriate assent from the minor if consent is by parent/guardian.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Age < 12 years; 2.Known contraindication, hypersensitivity or intolerance to pork or other porcine PEPs; 3.Current uncontrolled diabetes mellitus; 4.History of solid organ transplantation; 5.History of surgery affecting the bowel function and weight gain; 6.History of fibrosing colonopathy; 7.History of any other clinically significant cardiac, renal, neurological, gastrointestinal, hepatic or endocrine disease to CF, whose sequelae and/or treatment can interfere with the results of the study; 8.Any acute, respiratory infection in the previous 14 days requiring antibiotics; 9.Cancer or any other chronic diseases with life expectancy < 2 years; 10.Subjects treated with oral steroids in the last 8 weeks; 11.Subjects receiving nutritional supplements containing mediumchain triglycerides (MCT) to maintain weight gain; 12.Subjects that in the opinion of the investigator to have a significant medical and/or mental disease that would compromise the subject’s welfare, pose and unacceptable risk to him/her or confound the study results; 13.Subjects with evidence of alcohol or drug abuse that in the opinion of the investigator, could lead to noncompliance with study requirements, or otherwise unable to understand the nature, scope and possible consequences of the study; 14.Positive urine (dip-stick) pregnancy test (for subjects of childbearing potential); 15.Pregnant or lactating women; 16.Women of childbearing potential and not using adequate method of contraception for at least one month before randomization (i.e. barrier methods, intrauterine devices, hormonal treatment or sterilization); 17.Subjects who have been previously enrolled in this study; 18.Participation in an interventional clinical study within 90 days of the Screening Visit, or as applicable per specific country regulations/guidelines. Participation in observational studies is not an exclusion; 19.Subjects who cannot swallow size 0 capsules.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified