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

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 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690820
• Other study ID #: S245.3.127
• Status: Completed
• Phase: Phase 3
• First received: June 3, 2008
• Last updated: May 26, 2010
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: February 2010
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Exocrine Pancreatic Insufficiency
• Fibrosis
• Pancreatic Exocrine Insufficiency

Intervention

Drug:
• Pancrelipase Delayed Release
12,000 unit Capsules, dosed individually based on fat intake.
• Placebo Comparator
Placebo

Locations

Country	Name	City	State
United States	Site 8	Albuquerque	New Mexico
United States	Site 6	Ann Arbor	Michigan
United States	Site 9	Boston	Massachusetts
United States	Site 1	Cincinnati	Ohio
United States	Site 3	Hershey	Pennsylvania
United States	Site 2	Iowa City	Iowa
United States	Site 5	Louisville	Kentucky
United States	Site 4	Minneapolis	Minnesota
United States	Site 10	Oklahoma City	Oklahoma
United States	Site 7	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — 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 Formed/Normal Stools.	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.	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