Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine if PANCRECARB® MS-16 (pancrelipase) is safe and effective in reducing steatorrhea (as measured by 72-hour stool fat determinations) in children and adults with cystic fibrosis and pancreatic insufficiency.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Digestive Care, Inc.
• Treatments: Pancreatin; Pancrelipase

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