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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510484
• Other study ID #: S245.3.126
• Secondary ID: 2007-004005-10
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2007
• Last updated: May 26, 2010
• Start date: November 2007
• Est. completion date: March 2008

Study information

• Verified date: August 2009
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Exocrine Pancreatic Insufficiency
• Fibrosis

Intervention

Drug:
• Pancrelipase Delayed Release
24000 unit Capsule
• Placebo Comparator
Placebo

Locations

Country	Name	City	State
Hungary	Site 20	Petrofi
Israel	Site 21	Jerusalem
South Africa	Site 22	Johannesburg
Spain	Site 23	Barcelona
United States	Site 16	Albuquerque	New Mexico
United States	Site 8	Ann Arbor	Michigan
United States	Site 17	Boston	Massachusetts
United States	Site 19	Cincinnati	Ohio
United States	Site 12	Dayton	Ohio
United States	Site 3	Hershey	Pennsylvania
United States	Site 1	Iowa City	Iowa
United States	Site 11	Long Beach	California
United States	Site 18	Long Branch	New Jersey
United States	Site 10	Los Angeles	California
United States	Site 7	Louisville	Kentucky
United States	Site 5	Miami	Florida
United States	Site 6	Minneapolis	Minnesota
United States	Site 9	Nashville	Tennessee
United States	Site 14	Oklahoma City	Oklahoma
United States	Site 4	Orlando	Florida
United States	Site 15	Philadelphia	Pennsylvania
United States	Site 13	San Francisco	California
United States	Site 2	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

United States,  Hungary,  Israel,  South Africa,  Spain, 

References & Publications (1)

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 O — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of Fat Absorption (%)	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.	5 days	No
Secondary	Coefficient of Nitrogen Absorption (%)	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.	5 days	No
Secondary	Total Fat Excretion (Grams)	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.	5 days	No
Secondary	Total Stool Weight (Grams)	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.	5 days	No
Secondary	Stool Frequency	Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.	5 days	No
Secondary	Percentage of Days With no Flatulence.	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.	5 days	No
Secondary	Percentage of Days With no Abdominal Pain.	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.	5 days	No