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

Cystic Fibrosis Clinical Trial

Official title:

An Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00775528
• Other study ID #: S245.3.128
• Status: Completed
• Phase: Phase 3
• First received: October 17, 2008
• Last updated: October 25, 2010
• Start date: April 2009
• Est. completion date: June 2009

Study information

• Verified date: October 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 6 Years

Eligibility

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

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Pancrelipase Delayed Release
3,000, 6,000 and 12,000 unit Lipase Capsules

Locations

Country	Name	City	State
United States	Site 8	Albuquerque	New Mexico
United States	Site 6	Ann Arbor	Michigan
United States	Site 11	Boise	Idaho
United States	Site 9	Boston	Massachusetts
United States	Site 1	Cincinnati	Ohio
United States	Site 12	Detroit	Michigan
United States	Site 3	Hershey	Pennsylvania
United States	Site 13	Long Branch	New Jersey
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, McNamara J, Royall J, Caras S, Forssmann K. Safety and tolerability of a new formulation of pancrelipase delayed-release capsules (CREON) in children under seven years of age with exocrine pancreatic insufficiency due to cystic fibrosis: an open-label, multicentre, single-treatment-arm study. Clin Drug Investig. 2010;30(6):351-64. doi: 10.2165/11533390-000000000-00000. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)	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.	10 Days	Yes
Secondary	Stool Fat (% Fat)	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).	Last 3 days in a 10-day treatment period	No
Secondary	Fat Intake (g)	The mean daily fat intake was determined as the average of daily fat intake over a 3-day period.	Last 3 days in a 10-day treatment period	No
Secondary	Total Calorie Intake (kcal)	The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period.	Last 3 days in a 10-day treatment period	No