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

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00510484

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: Pancrelipase Delayed Release Drug: Placebo Comparator	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Coefficient of Fat Absorption (%) [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Coefficient of Nitrogen Absorption (%) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Total Fat Excretion (Grams) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Total Stool Weight (Grams) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Stool Frequency [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Percentage of Days With no Flatulence. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Percentage of Days With no Abdominal Pain. [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Enrollment:	35
Study Start Date:	November 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Pancrelipase Delayed Release 24000 unit Capsule
B: Placebo Comparator	Drug: Placebo Comparator Placebo

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00510484

Show 23 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Djenane Bennett )
Study ID Numbers:	S245.3.126, 2007-004005-10
Study First Received:	August 1, 2007
Results First Received:	May 29, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00510484 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Solvay Pharmaceuticals:

Pancreatic exocrine insufficiency
Cystic Fibrosis

Additional relevant MeSH terms:

Fibrosis
Gastrointestinal Agents
Pancrelipase
Pharmacologic Actions
Digestive System Diseases
Pathologic Processes
Cystic Fibrosis

Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Diseases
Therapeutic Uses
Pancreatic Diseases
Infant, Newborn, Diseases
Exocrine Pancreatic Insufficiency

ClinicalTrials.gov processed this record on February 08, 2010