A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ≥ 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Condition: Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: Creon®; Creon N
Intervention description: active comparator; experimental drug
Intervention MeSH terms: Pancrelipase; Pancreatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis

Summary:

      maldigestion of dietary macronutrients (pancreas not producing enough enzymes for digestion
      of fat, sugars and proteins) in Cystic Fibrosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent given by the subject, or the parents, or a legally acceptable
             representative. If required by the Institutional Review Board/Ethics Committee
             (IRB/IEC), assent will be given by the subject

          -  Age ≥ 12 years

          -  Subjects who are able to swallow capsules with each meal and snacks

          -  Diagnosis of Cystic Fibrosis (CF) confirmed by two positive chloride sweat tests or
             gene analysis

          -  Diagnosis of pancreatic exocrine insufficiency proven by:

               1. Coefficient of fat absorption (CFA) < 70% without supplementation

               2. or Human fecal elastase < 50 μg/g stool

          -  Currently receiving treatment with a commercially available pancreatic enzyme product
             and on a continuous dose of this product for more than 3 months

          -  Clinically stable condition without evidence of acute respiratory disease within 1
             month of enrollment

          -  Stable body weight defined as no more than a 5% decline within 3 months of enrolment

          -  Females of child-bearing potential should agree to continue using a medically
             acceptable method of birth control throughout the study and for 30 days immediately
             after the last dose of study drug. Medically acceptable methods of birth control
             include bilateral tubal ligation or the use of either a contraceptive implant, a
             contraceptive injection (Depo-Provera™), an intrauterine device, or an oral
             contraceptive taken within the past 3 months where the subject agrees to continue
             using during the study or to adopt another birth control method, or a double-barrier
             method which consists of a combination of any two of the following: diaphragm,
             cervical cap, condom, or spermicide.

        Exclusion Criteria:

          -  Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except
             underlying disease), hematologic/immunologic, head, ears, eyes, nose, throat,
             dermatologic/connective tissue, musculoskeletal, metabolic/nutritional (except
             underlying disease), endocrine (except diabetes mellitus), neurologic/psychiatric,
             allergy, recent major surgery, or other relevant diseases as revealed by history,
             physical examination and/or laboratory assessments, which could limit participation in
             or completion of the study

          -  History of acute abdomen

          -  History of fibrosing colonopathy

          -  History of distal intestinal obstruction syndrome (DIOS) within 6 months prior to
             enrollment

          -  Solid organ transplant or surgery affecting the large bowel other than appendectomy

          -  Small bowel surgery that significantly affected absorptive capacity (e.g. gastrectomy
             or pancreatectomy)

          -  Pregnancy or lactation

          -  Any type of malignancy involving the digestive tract in the last 5 years

          -  Celiac disease or Crohn's disease

          -  Known allergy to pancreatin or inactive ingredients (excipients) of pancreatin
             capsules

          -  Suspected non-compliance or non-cooperation

          -  Intake of experimental drugs within 30 days prior to study start

          -  Mental disability or any other lack of fitness, in the Investigator's opinion, to
             preclude subject's participation in or ability to complete the study

          -  Diagnosis of human immunodeficiency virus in medical history.