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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00510484
First received: August 1, 2007
Last updated: May 26, 2010
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
 Drug: Pancrelipase Delayed Release
Drug: Placebo Comparator
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Coefficient of Fat Absorption (%) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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:
  • Coefficient of Nitrogen Absorption (%) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 35
Study Start Date: November 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Pancrelipase Delayed Release
24000 unit Capsule
Placebo Comparator: B Drug: Placebo Comparator
Placebo

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510484

  Show 23 Study Locations
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: NCT00510484     History of Changes
Other Study ID Numbers: S245.3.126, 2007-004005-10
Study First Received: August 1, 2007
Results First Received: May 29, 2009
Last Updated: May 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Solvay Pharmaceuticals:
Pancreatic exocrine insufficiency
Cystic Fibrosis

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

ClinicalTrials.gov processed this record on June 18, 2013