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

S

Solvay Pharmaceuticals

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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