Clinical trial NCT00432861 (phase 3, status: completed)
Conditions: cystic fibrosis, pancreatic insufficiency
ICD codes: E84.9, Z14.1, E84.0, E84.11, E84.8, E84.19, P09.4, K86.81
Drugs: pancrecarb® (pancrelipase), placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female age ≥ 7 years

          -  Confirmed diagnosis of CF based on the following criteria: One or more clinical
             features consistent with the CF phenotype, AND Positive sweat chloride ≥ 60 mEq/liter
             (by pilocarpine iontophoresis), OR Genotype with two identifiable mutations consistent
             with CF

          -  Adequate nutritional status based on BMI: Age 7 years to 20 years old, Body Mass Index
             Percentile ≥ 5th percentile; Age > 20 years old, Body Mass Index for females ≥ 16.0,
             Body Mass Index for males ≥ 16.5

          -  Pancreatic insufficiency documented by spot fecal elastase-1 (FE 1) <= 100
             micrograms/g stool at the time of randomization

          -  Currently receiving pancreatic enzyme replacement therapy with a commercially
             available pancreatic enzyme

          -  Able to swallow size 0 capsules

          -  Clinically stable with no evidence of an acute medical condition

          -  Able to understand and sign a written informed consent or assent and comply with the
             requirements of the study

        Exclusion Criteria:

          -  History of fibrosing colonopathy

          -  History of significant bowel resection

          -  History of being refractory to pancreatic enzyme replacement therapy

          -  Solid organ transplant

          -  Abdominal surgery within past five (5) years

          -  A current diagnosis or a history of distal intestinal obstruction syndrome (DIOS) in
             the past six (6) months, or 2 or more episodes of DIOS in the past twelve (12) months

          -  Conditions known to increase fecal fat loss including: inflammatory bowel disease ,
             celiac disease, Crohn's disease, tropical Sprue, Whipple's disease

          -  A known contraindication, sensitivity or hypersensitivity to porcine pancreatic
             enzymes or food dyes (i.e., FD&C Blue No. 2)

          -  Active liver disease with liver enzymes (alanine aminotransferase (ALT/SGPT),
             aspartate aminotransferase (AST/SGOT) or bilirubin ≥ 3 times the upper limit of normal

          -  Acute pancreatitis or acute exacerbation of chronic pancreatitis

          -  Acute treatment with any systemic (oral or IV) antibiotics two (2) weeks prior to
             screening

          -  Treatment with erythromycin and unwilling to discontinue the treatment two (2) weeks
             prior to the screening. (azithromycin is allowed)

          -  Change in chronic treatment with systemic (oral and IV) antibiotics during the trial
             NOTE: Study subject may remain on a chronic regimen of systemic (oral or IV)
             antibiotics (with exception of erythromycin), if he/she started the antibiotics at
             least 2 weeks prior to study screening, was at his/her usual bowel pattern at the time
             of screening, and does not stop or change these antibiotics during the study period.

          -  Receiving enteral tube feeding during the study

          -  Expected inability to cooperate with or be non-adherent to required study procedures

          -  Pregnant, breast-feeding, or unwilling to practice birth control (for females of
             child-bearing potential) during participation in the study

          -  Use of narcotics

          -  Poorly controlled diabetes

          -  Participation in an investigational study of a drug, biologic, or device not currently
             approved for marketing, within 30 days of screening visit

          -  A medical condition which the investigator deems significant enough to interfere with
             the ability of the study patient to participate in the trial or interfering with
             assessment of effects of enzyme therapy on fat absorption