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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00510484
Recruitment Status : Completed
First Posted : August 2, 2007
Results First Posted : July 20, 2009
Last Update Posted : June 3, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Pancrelipase Delayed Release Drug: Placebo Comparator Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2007
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: A Drug: Pancrelipase Delayed Release
24000 unit Capsule
Placebo Comparator: B Drug: Placebo Comparator
Placebo


Outcome Measures

Primary Outcome Measures :
  1. Coefficient of Fat Absorption (%) [ Time Frame: 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 :
  1. Coefficient of Nitrogen Absorption (%) [ Time Frame: 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.

  2. Total Fat Excretion (Grams) [ Time Frame: 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.

  3. Total Stool Weight (Grams) [ Time Frame: 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.

  4. Stool Frequency [ Time Frame: 5 days ]
    Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.

  5. Percentage of Days With no Flatulence. [ Time Frame: 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.

  6. Percentage of Days With no Abdominal Pain. [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: August 2, 2007    Key Record Dates
Results First Posted: July 20, 2009
Last Update Posted: June 3, 2010
Last Verified: August 2009

Keywords provided by Solvay Pharmaceuticals:
Pancreatic exocrine insufficiency
Cystic Fibrosis

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