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

October 25, 2010 updated by: Solvay Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

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

  • United States
    • Idaho
      • Boise, Idaho, United States
        • Site 11
    • Kentucky
      • Louisville, Kentucky, United States
        • Site 5
    • Massachusetts
      • Boston, Massachusetts, United States
        • Site 9
    • Michigan
      • Ann Arbor, Michigan, United States
        • Site 6
      • Detroit, Michigan, United States
        • Site 12
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Site 4
    • New Jersey
      • Long Branch, New Jersey, United States
        • Site 13
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Site 8
    • Ohio
      • Cincinnati, Ohio, United States
        • Site 1
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Site 10
      • Oklahoma City, Oklahoma, United States
        • Site 7
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Site 3

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

1 month to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: Pancrelipase Delayed Release
3,000, 6,000 and 12,000 unit Lipase Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE)
Time Frame: 10 Days
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool Fat (% Fat)
Time Frame: Last 3 days in a 10-day treatment period
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
Fat Intake (g)
Time Frame: Last 3 days in a 10-day treatment period
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
Total Calorie Intake (kcal)
Time Frame: Last 3 days in a 10-day treatment period
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

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

April 1, 2009

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 17, 2008

First Submitted That Met QC Criteria

October 17, 2008

First Posted (Estimate)

October 20, 2008

Study Record Updates

Last Update Posted (Estimate)

November 7, 2010

Last Update Submitted That Met QC Criteria

October 25, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S245.3.128

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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