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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Cystic Fibrosis	Drug: Pancrelipase Delayed Release; Drug: Placebo Comparator	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	35 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, 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
Study Start Date :	November 2007
Actual Primary Completion Date :	March 2008
Actual Study Completion Date :	March 2008

Arms and Interventions

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Arm	Intervention/treatment
Experimental: A	Drug: Pancrelipase Delayed Release; 24000 unit Capsule
Placebo Comparator: B	Drug: Placebo Comparator; Placebo

Outcome Measures

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Primary Outcome Measures :

1. Coefficient of Fat Absorption (%) [ Time Frame: 5 days ]
   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 :

1. Coefficient of Nitrogen Absorption (%) [ Time Frame: 5 days ]
   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.
2. Total Fat Excretion (Grams) [ Time Frame: 5 days ]
   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.
3. Total Stool Weight (Grams) [ Time Frame: 5 days ]
   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.
4. Stool Frequency [ Time Frame: 5 days ]
   Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.
5. Percentage of Days With no Flatulence. [ Time Frame: 5 days ]
   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.
6. Percentage of Days With no Abdominal Pain. [ Time Frame: 5 days ]
   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.

Eligibility Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 23 Study Locations

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:	Global Clinical Director Solvay	Solvay Pharmaceuticals

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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
First Posted:	August 2, 2007
Results First Posted:	July 20, 2009
Last Update Posted:	June 3, 2010
Last Verified:	August 2009

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