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

Phase 3

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Pancrelipase Delayed Release; Drug: Placebo Comparator

• Registration Number: NCT00510484
• Lead Sponsor: Solvay Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-01
• Study First Posted: 2007-08-02
• Study Start: 2007-11
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2009-05-29
• Results First Submitted QC: 2009-05-29
• Results First Posted: 2009-07-20
• Status Verified: 2009-08
• Last Update Submitted: 2010-05-26
• Last Update Posted: 2010-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Pancrelipase Delayed Release	-
B	Placebo Comparator	-

Primary Outcome Measures

Name	Time	Method
Coefficient of Fat Absorption (%)	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

Name	Time	Method
Coefficient of Nitrogen Absorption (%)	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.
Total Fat Excretion (Grams)	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.
Total Stool Weight (Grams)	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.
Stool Frequency	5 days	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.	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.
Percentage of Days With no Abdominal Pain.	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.

Trial Locations

Locations (23)

Site 20; 🇭🇺 Petrofi, Hungary

Site 7; 🇺🇸 Louisville, Kentucky, United States

Site 12; 🇺🇸 Dayton, Ohio, United States

Site 22; 🇿🇦 Johannesburg, South Africa

Site 2; 🇺🇸 Toledo, Ohio, United States

Site 3; 🇺🇸 Hershey, Pennsylvania, United States

Site 10; 🇺🇸 Los Angeles, California, United States

Site 13; 🇺🇸 San Francisco, California, United States

Site 17; 🇺🇸 Boston, Massachusetts, United States

Site 6; 🇺🇸 Minneapolis, Minnesota, United States

Site 19; 🇺🇸 Cincinnati, Ohio, United States

Site 14; 🇺🇸 Oklahoma City, Oklahoma, United States

Site 15; 🇺🇸 Philadelphia, Pennsylvania, United States

Site 9; 🇺🇸 Nashville, Tennessee, United States

Site 4; 🇺🇸 Orlando, Florida, United States

Site 5; 🇺🇸 Miami, Florida, United States

Site 1; 🇺🇸 Iowa City, Iowa, United States

Site 18; 🇺🇸 Long Branch, New Jersey, United States

Site 8; 🇺🇸 Ann Arbor, Michigan, United States

Site 23; 🇪🇸 Barcelona, Spain

Site 11; 🇺🇸 Long Beach, California, United States

Site 16; 🇺🇸 Albuquerque, New Mexico, United States

Site 21; 🇮🇱 Jerusalem, Israel