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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pancrelipase Delayed Release
Placebo Comparator
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Pancreatic exocrine insufficiency, Cystic Fibrosis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site 11
  • Site 10
  • Site 13
  • Site 5
  • Site 4
  • Site 1
  • Site 7
  • Site 17
  • Site 8
  • Site 6
  • Site 18
  • Site 16
  • Site 19
  • Site 12
  • Site 2
  • Site 14
  • Site 3
  • Site 15
  • Site 9
  • Site 20
  • Site 21
  • Site 22
  • Site 23

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Coefficient of Fat Absorption (%)
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 (%)
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)
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)
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
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.
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.
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.

Full Information

First Posted
August 1, 2007
Last Updated
May 26, 2010
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00510484
Brief Title
Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Pancreatic exocrine insufficiency, Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pancrelipase Delayed Release
Intervention Description
24000 unit Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Coefficient of Fat Absorption (%)
Description
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.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Coefficient of Nitrogen Absorption (%)
Description
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.
Time Frame
5 days
Title
Total Fat Excretion (Grams)
Description
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.
Time Frame
5 days
Title
Total Stool Weight (Grams)
Description
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.
Time Frame
5 days
Title
Stool Frequency
Description
Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.
Time Frame
5 days
Title
Percentage of Days With no Flatulence.
Description
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.
Time Frame
5 days
Title
Percentage of Days With no Abdominal Pain.
Description
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.
Time Frame
5 days
Other Pre-specified Outcome Measures:
Title
Percentage of Days With Formed/Normal Stools.
Description
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.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 11
City
Long Beach
State/Province
California
Country
United States
Facility Name
Site 10
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Site 13
City
San Francisco
State/Province
California
Country
United States
Facility Name
Site 5
City
Miami
State/Province
Florida
Country
United States
Facility Name
Site 4
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Site 1
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Site 7
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Site 17
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Site 8
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Site 6
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Site 18
City
Long Branch
State/Province
New Jersey
Country
United States
Facility Name
Site 16
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Site 19
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 12
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Site 2
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
Site 14
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Site 3
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Site 15
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 9
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Site 20
City
Petrofi
Country
Hungary
Facility Name
Site 21
City
Jerusalem
Country
Israel
Facility Name
Site 22
City
Johannesburg
Country
South Africa
Facility Name
Site 23
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19815466
Citation
Trapnell BC, Maguiness K, Graff GR, Boyd D, Beckmann K, Caras S. Efficacy and safety of Creon 24,000 in subjects with exocrine pancreatic insufficiency due to cystic fibrosis. J Cyst Fibros. 2009 Dec;8(6):370-7. doi: 10.1016/j.jcf.2009.08.008. Epub 2009 Oct 7.
Results Reference
result

Learn more about this trial

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

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