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

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00690820

Purpose

This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 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 ]
This coefficient is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.

Secondary Outcome Measures:

Coefficient of Nitrogen Absorption (%) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
This coefficient is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.
Total Fat Excretion (Grams) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.
Total Stool Weight (Grams) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.
Stool Frequency [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.
Percentage of Days With no Flatulence. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
The percentage of days with no flatulence is calculated from the diary during the treatment period: 100*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.
Percentage of Days With Formed/Normal Stools. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.
Percentage of Days With no Abdominal Pain. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.

Enrollment:	17
Study Start Date:	June 2008
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: Pancrelipase Delayed Release 12,000 unit Capsules, dosed individually based on fat intake.
Placebo Comparator: B	Drug: Placebo Comparator Placebo

Eligibility

Ages Eligible for Study:	7 Years to 11 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
Confirmed PEI by historical Coefficient of fat Absorption < 70% without supplementation or current or historical fecal elastase < 50µg/stool (within the last 12 months)
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
Stable body weight and agrees to abstain from sexual activity

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: NCT00690820

Locations

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
United States, Minnesota
Site 4
Minneapolis, Minnesota, 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, Maguiness K, McNamara J, Morton R, Boyd D, Beckmann K, Bennett D. Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. Clin Ther. 2010 Jan;32(1):89-103.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Caras S, Boyd D, Zipfel L, Sander-Struckmeier S. Evaluation of stool collections to measure efficacy of PERT in subjects with exocrine pancreatic insufficiency. J Pediatr Gastroenterol Nutr. 2011 Dec;53(6):634-40.

Responsible Party:	Djenane Bennett, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00690820 History of Changes
Other Study ID Numbers:	S245.3.127
Study First Received:	June 3, 2008
Results First Received:	November 30, 2009
Last Updated:	May 26, 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