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

Sponsor:	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 Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.

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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age 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:

Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE) [ Time Frame: 10 Days ] [ Designated as safety issue: Yes ]
Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake.

Secondary Outcome Measures:

Stool Fat (% Fat) [ Time Frame: Last 3 days in a 10-day treatment period ] [ Designated as safety issue: No ]
The stool fat content was calculated as percent fat of dry solid weight per bowel movement. Stool fat per patient was derived as mean over three bowel movements sampled (i.e. one sample per day).
Fat Intake (g) [ Time Frame: Last 3 days in a 10-day treatment period ] [ Designated as safety issue: No ]
The mean daily fat intake was determined as the average of daily fat intake over a 3-day period.
Total Calorie Intake (kcal) [ Time Frame: Last 3 days in a 10-day treatment period ] [ Designated as safety issue: No ]
The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period.

Enrollment:	19
Study Start Date:	April 2009
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

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

Eligibility

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

Criteria

Inclusion Criteria:

Confirmed Cystic Fibrosis (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

Locations

United States, Idaho
Site 11
Boise, Idaho, 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

Publications:

Graff GR, McNamara J, Royall J, Caras S, Forssmann K. Safety and tolerability of a new formulation of pancrelipase delayed-release capsules (CREON) in children under seven years of age with exocrine pancreatic insufficiency due to cystic fibrosis: an open-label, multicentre, single-treatment-arm study. Clin Drug Investig. 2010;30(6):351-64.

Responsible Party:	Djenane Bennett, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00775528 History of Changes
Other Study ID Numbers:	S245.3.128
Study First Received:	October 17, 2008
Results First Received:	September 9, 2010
Last Updated:	October 25, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

Cystic Fibrosis
Pancreatic Exocrine Insufficiency

Additional relevant MeSH terms:

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

Infant, Newborn, Diseases
Pathologic Processes
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012