Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)

Solvay

Status and phase

Completed

Phase 3

Conditions

Cystic Fibrosis

Pancreatic Exocrine Insufficiency

Treatments

Drug: Placebo Comparator

Drug: Pancrelipase Delayed Release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00690820

S245.3.127

Details and patient eligibility

About

This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.

Enrollment

17 patients

Sex

All

Ages

7 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
Confirmed PEI by historical Coefficient of fat Absorption < 70% without supplementation or current or historical fecal elastase < 50µg/stool (within the last 12 months)
Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
Clinically stable condition without evidence of acute respiratory disease or any other acute condition
Stable body weight and agrees to abstain from sexual activity

Exclusion criteria

Ileus or acute abdomen
History of fibrosing colonopathy, celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome
History of distal ileal obstruction syndrome within 6 months of enrollment
Use of an immunosuppressive drug
Any type of malignancy involving the digestive tract in the last 5 years
Known infection with HIV