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

Phase 3

Completed

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

• Registration Number: NCT00775528
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-17
• Study First Submitted QC: 2008-10-17
• Study First Posted: 2008-10-20
• Study Start: 2009-04
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-09-09
• Results First Submitted QC: 2010-09-09
• Status Verified: 2010-10
• Results First Posted: 2010-10-01
• Last Update Submitted: 2010-10-25
• Last Update Posted: 2010-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene analysis
• Current or historical human fecal elastase < 50µg/gstool
• Weight greater than 3.75 kg
• Age 1 month to 6 years
• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Pancrelipase Delayed Release	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)	10 Days	Treatment Emergent Adverse Events are defined as adverse events started at or after the first administration of study drug and include those events started prior to the first administration but which worsened after the first intake.

Secondary Outcome Measures

Name	Time	Method
Stool Fat (% Fat)	Last 3 days in a 10-day treatment period	The stool fat content was calculated as percent fat of dry solid weight per bowel movement. Stool fat per patient was derived as mean over three bowel movements sampled (i.e. one sample per day).
Fat Intake (g)	Last 3 days in a 10-day treatment period	The mean daily fat intake was determined as the average of daily fat intake over a 3-day period.
Total Calorie Intake (kcal)	Last 3 days in a 10-day treatment period	The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period.

Trial Locations

Locations (12)

Site 9; 🇺🇸 Boston, Massachusetts, United States

Site 5; 🇺🇸 Louisville, Kentucky, United States

Site 12; 🇺🇸 Detroit, Michigan, United States

Site 4; 🇺🇸 Minneapolis, Minnesota, United States

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

Site 1; 🇺🇸 Cincinnati, Ohio, United States

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

Site 11; 🇺🇸 Boise, Idaho, United States

Site 3; 🇺🇸 Hershey, Pennsylvania, United States

Site 13; 🇺🇸 Long Branch, New Jersey, United States

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

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