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

Solvay

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: Pancrelipase Delayed Release; Drug: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00510484

2007-004005-10

S245.3.126

Details and patient eligibility

About

This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.

Enrollment: 35 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
• Confirmed PEI by historical CFA < 70% without supplementation or current or historical fecal elastase < 50µg/g stool (within the last 12 months)
• Subjects of 12 years or older
• 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
• Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

Exclusion criteria

• Ileus or acute abdomen
• History of fibrosing colonopathy
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: Pancrelipase Delayed Release

B

Placebo Comparator group

Treatment:

Drug: Placebo Comparator