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

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ClinicalTrials.gov Identifier: NCT00414908
Recruitment Status : Completed
First Posted : December 22, 2006
Results First Posted : September 16, 2009
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Pancreatectomy Pancreatic Exocrine Insufficiency Drug: Pancrelipase delayed release capsule Drug: Placebo Comparator Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy
Study Start Date : October 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arm Intervention/treatment
Experimental: A Drug: Pancrelipase delayed release capsule
24,000 unit capsule

Placebo Comparator: B Drug: Placebo Comparator
Placebo




Primary Outcome Measures :
  1. 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).



Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414908


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

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Responsible Party: Gregor Eibes, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00414908     History of Changes
Other Study ID Numbers: S245.3.124
2004-000227-15 ( EudraCT Number )
First Posted: December 22, 2006    Key Record Dates
Results First Posted: September 16, 2009
Last Update Posted: August 10, 2011
Last Verified: August 2011
Keywords provided by Solvay Pharmaceuticals:
Chronic Pancreatitis
Pancreatectomy
Pancreatic Exocrine Insufficiency
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents