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

Phase 3

Completed

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

• Registration Number: NCT00690820
• Lead Sponsor: Solvay Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2009-11-30
• Status Verified: 2010-02
• Results First Submitted QC: 2010-02-03
• Results First Posted: 2010-03-10
• Last Update Submitted: 2010-05-26
• Last Update Posted: 2010-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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 Formed/Normal Stools.	5 days	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.
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 (10)

Site 10; 🇺🇸 Oklahoma City, Oklahoma, United States

Site 2; 🇺🇸 Iowa City, Iowa, United States

Site 5; 🇺🇸 Louisville, Kentucky, United States

Site 4; 🇺🇸 Minneapolis, Minnesota, United States

Site 1; 🇺🇸 Cincinnati, Ohio, United States

Site 8; 🇺🇸 Albuquerque, New Mexico, United States

Site 7; 🇺🇸 Oklahoma City, Oklahoma, United States

Site 3; 🇺🇸 Hershey, Pennsylvania, United States

Site 9; 🇺🇸 Boston, Massachusetts, United States

Site 6; 🇺🇸 Ann Arbor, Michigan, United States