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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00775528
First received: October 17, 2008
Last updated: October 25, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Pancreatic Exocrine Insufficiency
Drug: Pancrelipase Delayed Release
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE) [ Time Frame: 10 Days ] [ Designated as safety issue: Yes ]
    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:
  • Stool Fat (% Fat) [ Time Frame: Last 3 days in a 10-day treatment period ] [ Designated as safety issue: No ]
    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) [ Time Frame: Last 3 days in a 10-day treatment period ] [ Designated as safety issue: No ]
    The mean daily fat intake was determined as the average of daily fat intake over a 3-day period.

  • Total Calorie Intake (kcal) [ Time Frame: Last 3 days in a 10-day treatment period ] [ Designated as safety issue: No ]
    The total calorie intake was determined as the average of total calorie of daily food intake intake over a 3-day period.


Enrollment: 19
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Pancrelipase Delayed Release
3,000, 6,000 and 12,000 unit Lipase Capsules

  Eligibility

Ages Eligible for Study:   1 Month to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775528

Locations
United States, Idaho
Site 11
Boise, Idaho, United States
United States, Kentucky
Site 5
Louisville, Kentucky, United States
United States, Massachusetts
Site 9
Boston, Massachusetts, United States
United States, Michigan
Site 6
Ann Arbor, Michigan, United States
Site 12
Detroit, Michigan, United States
United States, Minnesota
Site 4
Minneapolis, Minnesota, United States
United States, New Jersey
Site 13
Long Branch, New Jersey, United States
United States, New Mexico
Site 8
Albuquerque, New Mexico, United States
United States, Ohio
Site 1
Cincinnati, Ohio, United States
United States, Oklahoma
Site 7
Oklahoma City, Oklahoma, United States
Site 10
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Site 3
Hershey, Pennsylvania, United States
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Publications:
Responsible Party: Djenane Bennett, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00775528     History of Changes
Other Study ID Numbers: S245.3.128
Study First Received: October 17, 2008
Results First Received: September 9, 2010
Last Updated: October 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Cystic Fibrosis
Pancreatic Exocrine Insufficiency

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014