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

Primary Purpose

Cystic Fibrosis, Pancreatic Exocrine Insufficiency

Status
Completed
Phase
Phase 3
Locations
United States
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 Cystic Fibrosis, Pancreatic Exocrine Insufficiency

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
  • Confirmed PEI by historical Coefficient of fat Absorption < 70% without supplementation or current or historical fecal elastase < 50µg/stool (within the last 12 months)
  • 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
  • Stable body weight and agrees to abstain from sexual activity

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

Sites / Locations

  • Site 2
  • Site 5
  • Site 9
  • Site 6
  • Site 4
  • Site 8
  • Site 1
  • Site 10
  • Site 7
  • Site 3

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 Formed/Normal Stools.
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.
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
June 3, 2008
Last Updated
May 26, 2010
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00690820
Brief Title
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
Official Title
A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency 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, Pancreatic Exocrine Insufficiency
Keywords
Cystic Fibrosis, Pancreatic Exocrine Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (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
12,000 unit Capsules, dosed individually based on fat intake.
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 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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 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 Coefficient of fat Absorption < 70% without supplementation or current or historical fecal elastase < 50µg/stool (within the last 12 months) 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 Stable body weight and agrees to abstain from sexual activity 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
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 2
City
Iowa City
State/Province
Iowa
Country
United States
Facility Name
Site 5
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Site 9
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Site 6
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Site 4
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Site 8
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Site 1
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 10
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Site 7
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Site 3
City
Hershey
State/Province
Pennsylvania
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20171415
Citation
Graff GR, Maguiness K, McNamara J, Morton R, Boyd D, Beckmann K, Bennett D. Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. Clin Ther. 2010 Jan;32(1):89-103. doi: 10.1016/j.clinthera.2010.01.012.
Results Reference
result
PubMed Identifier
21681115
Citation
Caras S, Boyd D, Zipfel L, Sander-Struckmeier S. Evaluation of stool collections to measure efficacy of PERT in subjects with exocrine pancreatic insufficiency. J Pediatr Gastroenterol Nutr. 2011 Dec;53(6):634-40. doi: 10.1097/MPG.0b013e3182281c38.
Results Reference
derived

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

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