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

May 26, 2010 updated by: Solvay Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Petrofi, Hungary
        • Site 20
  • Israel
      • Jerusalem, Israel
        • Site 21
  • South Africa
      • Johannesburg, South Africa
        • Site 22
  • Spain
      • Barcelona, Spain
        • Site 23
  • United States
    • California
      • Long Beach, California, United States
        • Site 11
      • Los Angeles, California, United States
        • Site 10
      • San Francisco, California, United States
        • Site 13
    • Florida
      • Miami, Florida, United States
        • Site 5
      • Orlando, Florida, United States
        • Site 4
    • Iowa
      • Iowa City, Iowa, United States
        • Site 1
    • Kentucky
      • Louisville, Kentucky, United States
        • Site 7
    • Massachusetts
      • Boston, Massachusetts, United States
        • Site 17
    • Michigan
      • Ann Arbor, Michigan, United States
        • Site 8
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Site 6
    • New Jersey
      • Long Branch, New Jersey, United States
        • Site 18
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Site 16
    • Ohio
      • Cincinnati, Ohio, United States
        • Site 19
      • Dayton, Ohio, United States
        • Site 12
      • Toledo, Ohio, United States
        • Site 2
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Site 14
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Site 3
      • Philadelphia, Pennsylvania, United States
        • Site 15
    • Tennessee
      • Nashville, Tennessee, United States
        • Site 9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days
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.
5 days
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.
5 days
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 days
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.
5 days
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.
5 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Days With Formed/Normal Stools.
Time Frame: 5 days
The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

August 1, 2007

First Submitted That Met QC Criteria

August 1, 2007

First Posted (Estimate)

August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

June 3, 2010

Last Update Submitted That Met QC Criteria

May 26, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S245.3.126
  • 2007-004005-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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