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

This study is not yet open for participant recruitment.

Verified by Solvay Pharmaceuticals, November 2008

Sponsored by:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00775528

Purpose

This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with PEI due to Cystic Fibrosis.

Condition	Intervention	Phase
Cystic Fibrosis Pancreatic Exocrine Insufficiency	Drug: Pancrelipase Delayed Release	Phase III

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Open Label, Multi-Center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children up to 6 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Clinical Symptomatology [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Vital Signs [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Pancrelipase Delayed Release 3,000, 6,000 and 12,000 unit Capsules

Eligibility

Ages Eligible for Study:	1 Month to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
Current or historical human fecal elastase < 50µg/gstool
Weight greater than 3.75 kg
Age 1 month to 6 years
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775528

Contacts

Contact: Djenane Bennett

djenane.bennett@solvay.com

Locations

United States, Idaho
Site 11
Boise, Idaho, United States
United States, Iowa
Site 2
Iowa City, Iowa, United States
United States, Kentucky
Site 5
Louisville, Kentucky, United States
United States, Massachusetts
Site 9
Boston, Massachusetts, United States
United States, Michigan
Site 6
Ann Arbor, Michigan, United States
Site 12
Detroit, Michigan, United States
United States, Minnesota
Site 4
Minneapolis, Minnesota, United States
United States, New Jersey
Site 13
Long Branch, New Jersey, United States
United States, New Mexico
Site 8
Albuquerque, New Mexico, United States
United States, Ohio
Site 1
Cincinnati, Ohio, United States
United States, Oklahoma
Site 7
Oklahoma City, Oklahoma, United States
Site 10
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Site 3
Hershey, Pennsylvania, United States

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

Responsible Party:	Solvay Pharmaceuticals ( Djenane Bennett )
Study ID Numbers:	S245.3.128
Study First Received:	October 17, 2008
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00775528
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

Cystic Fibrosis
Pancreatic Exocrine Insufficiency

Study placed in the following topic categories:

Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis

Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Pancrelipase
Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes
Therapeutic Uses
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009