A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy

August 8, 2011 updated by: Solvay Pharmaceuticals
This study assessed the effect of pancrelipase delayed release capsules on fat and nitrogen absorption in subjects with PEI due to Chronic Pancreatitis and Pancreatectomy. There was a run-in with a 5-day of single-blind placebo treatment, followed by a 7-day Double-blind period and a 6-month Open-Label Follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

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

  • Bulgaria
      • Sofia, Bulgaria
        • Site 23
  • Poland
      • Warsaw, Poland
        • Site 27
  • Puerto Rico
      • San Juan, Puerto Rico
        • Site 19
  • Russian Federation
      • Leningrad, Russian Federation
        • Site 25
  • Serbia
      • Belgrade, Serbia
        • Site 26
  • South Africa
      • Cape Town, South Africa
        • Site 24
  • Ukraine
      • Kiev, Ukraine
        • Site 28
  • United States
    • Arizona
      • Scottsdale, Arizona, United States
        • Site 9
    • Connecticut
      • Bristol, Connecticut, United States
        • Site 22
    • Florida
      • Tampa, Florida, United States
        • Site 7
    • Georgia
      • Atlanta, Georgia, United States
        • Site 6
    • Illinois
      • Chicago, Illinois, United States
        • Site 17
      • Maywood, Illinois, United States
        • Site 30
    • Indiana
      • Indianapolis, Indiana, United States
        • Site 14
    • Kansas
      • Kansas City, Kansas, United States
        • Site 15
    • Kentucky
      • Lexington, Kentucky, United States
        • Site 16
    • Louisiana
      • New Orleans, Louisiana, United States
        • Site 12
    • Massachusetts
      • Boston, Massachusetts, United States
        • Site 3
    • Michigan
      • Ann Arbor, Michigan, United States
        • Site 2
      • Grand Rapids, Michigan, United States
        • Site 29
    • Mississippi
      • Tupelo, Mississippi, United States
        • Site 1
    • Missouri
      • St. Louis, Missouri, United States
        • Site 5
    • New Jersey
      • Cedar Knolls, New Jersey, United States
        • Site 8
    • North Carolina
      • Boone, North Carolina, United States
        • Site 20
      • Rutherford College, North Carolina, United States
        • Site 4
    • Ohio
      • Cincinnati, Ohio, United States
        • Site 10
      • Cleveland, Ohio, United States
        • Site 11
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Site 21
    • Texas
      • Dallas, Texas, United States
        • Site 13
    • Virginia
      • Richmond, Virginia, United States
        • Site 18

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Pancreatic exocrine insufficiency has to be proven (in medical history) by the following criteria:

  • Direct or indirect pancreatic function test (except stool fat excretion) or Clinical signs of severe steatorrhoea that resolved upon administration of pancreatic supplementation.
  • Total stool fat > 40 g over 4 days (using Van De Kamer method)
  • Proven chronic pancreatitis
  • Females of child-bearing potential must agree to continue using a medically acceptable method of birth control

Exclusion Criteria:

  • Ileus or acute abdomen
  • Any type of malignancy involving the digestive tract in the last 5 years
  • Presence of pseudo-pancreatic cyst ≥ 4
  • Continued excessive intake of alcohol or drug abuse
  • 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 capsule
24,000 unit capsule
Placebo Comparator: B
Drug: Placebo Comparator
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Coefficient of Fat Absorption (CFA) (%) Between Baseline and End of Double-blind (DB) Period.
Time Frame: End of double-blind period (5-7 days)

The CFA is calculated from fat intake and fat excretion : 100*[fat intake-fat excretion]/fat intake. Higher values indicated a better response.

Change is calculated as (DB CFA-Baseline CFA).
End of double-blind period (5-7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Coefficient of Nitrogen Absorption (CNA) (%) Between Baseline and End of Double-blind (DB) Period.
Time Frame: End of double-blind period (5-7 days)
The CNA is calculated from nitrogen intake and nitrogen excretion : 100*[nitrogen intake-nitrogen excretion]/nitrogen intake. Higher values indicated a better response. Change is calculated as (DB CNA-Baseline CNA).
End of double-blind period (5-7 days)
Change From Baseline of Stool Fat (g) Between Baseline and End of Double-blind (DB) Period.
Time Frame: End of double-blind period (5-7 days)
Total amount of fat excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool fat - Baseline stool fat).
End of double-blind period (5-7 days)
Change From Baseline of Stool Nitrogen (g) Between Baseline and End of Double-blind (DB) Period.
Time Frame: End of double-period (5-7 days)
Total amount of nitrogen excreted during the stool collection period. Lower values indicate a better response. Change was calculated as (DB Stool nitrogen - Baseline stool nitrogen).
End of double-period (5-7 days)
Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period
Time Frame: End of double-period (5-7 days)
Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response. Change was calculated as (DB stool frequency - Baseline Stool frequency).
End of double-period (5-7 days)
Abdominal Pain at the End of the Double-blind Period.
Time Frame: End of double-period (5-7 days)
4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).
End of double-period (5-7 days)
Stool Consistency at the End of the Double-blind Period
Time Frame: End of double-period (5-7 days)
4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).
End of double-period (5-7 days)
Flatulence at the End of Double-blind Period
Time Frame: End of double-period (5-7 days)
4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).
End of double-period (5-7 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Stool Frequency Between "Original" Baseline and End of Open-label Period (OL)
Time Frame: 27 weeks
Stool frequency is the average of the daily number of stools recorded during the OL period. Lower values indicate a better response. Change was calculated as (OL stool frequency - Baseline stool frequency).
27 weeks

Collaborators and Investigators

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

Sponsor

Solvay Pharmaceuticals

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

October 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

December 21, 2006

First Submitted That Met QC Criteria

December 21, 2006

First Posted (Estimate)

December 22, 2006

Study Record Updates

Last Update Posted (Estimate)

August 10, 2011

Last Update Submitted That Met QC Criteria

August 8, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S245.3.124
  • 2004-000227-15

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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