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

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel 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 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: Pancreatin Pancrelipase

Genetic and Rare Diseases Information Center resources: Cystic Fibrosis

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

Eligibility


Ages Eligible for Study:	12 Years and older (Child, Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:

Trapnell BC, Maguiness K, Graff GR, Boyd D, Beckmann K, Caras S. Efficacy and safety of Creon 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2009 Dec;8(6):370-7. doi: 10.1016/j.jcf.2009.08.008. Epub 2009 Oct 7.


Responsible Party:	Djenane Bennett, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00510484 History of Changes
Other Study ID Numbers:	S245.3.126 2007-004005-10
Study First Received:	August 1, 2007
Results First Received:	May 29, 2009
Last Updated:	May 26, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Solvay Pharmaceuticals:


Pancreatic exocrine insufficiency Cystic Fibrosis

Additional relevant MeSH terms:


Fibrosis Cystic Fibrosis Exocrine Pancreatic Insufficiency Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases	Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pancrelipase Pancreatin Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 23, 2016