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

Information source: Solvay Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Pancrelipase Delayed Release (Drug); Placebo Comparator (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

Summary

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.

Clinical Details

Official title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Coefficient of Fat Absorption (%)

Secondary outcome:

Coefficient of Nitrogen Absorption (%)

Total Fat Excretion (Grams)

Total Stool Weight (Grams)

Stool Frequency

Percentage of Days With no Flatulence.

Percentage of Days With no Abdominal Pain.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Site 20, Petrofi, Hungary

Site 21, Jerusalem, Israel

Site 22, Johannesburg, South Africa

Site 23, Barcelona, Spain

Site 11, Long Beach, California, United States

Site 10, Los Angeles, California, United States

Site 13, San Francisco, California, United States

Site 5, Miami, Florida, United States

Site 4, Orlando, Florida, United States

Site 1, Iowa City, Iowa, United States

Site 7, Louisville, Kentucky, United States

Site 17, Boston, Massachusetts, United States

Site 8, Ann Arbor, Michigan, United States

Site 6, Minneapolis, Minnesota, United States

Site 18, Long Branch, New Jersey, United States

Site 16, Albuquerque, New Mexico, United States

Site 19, Cincinnati, Ohio, United States

Site 12, Dayton, Ohio, United States

Site 2, Toledo, Ohio, United States

Site 14, Oklahoma City, Oklahoma, United States

Site 3, Hershey, Pennsylvania, United States

Site 15, Philadelphia, Pennsylvania, United States

Site 9, Nashville, Tennessee, United States

Additional Information

Starting date: November 2007
Last updated: May 26, 2010

Page last updated: August 23, 2015

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