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

This study has been completed.
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00414908
First received: December 21, 2006
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Chronic Pancreatitis
Pancreatectomy
Pancreatic Exocrine Insufficiency
Drug: Pancrelipase delayed release capsule
Drug: Placebo Comparator
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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:
  • 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) ] [ Designated as safety issue: No ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    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).

  • Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
    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).

  • Abdominal Pain at the End of the Double-blind Period. [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
    4- point ordinal scale on this symptom from 0 (No Abdominal pain) to 3 (Severe abdominal pain).

  • Stool Consistency at the End of the Double-blind Period [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
    4- point ordinal scale on this symptom from 0 (Hard) to 3 (Watery).

  • Flatulence at the End of Double-blind Period [ Time Frame: End of double-period (5-7 days) ] [ Designated as safety issue: No ]
    4- point ordinal scale on this symptom from 0 (None) to 3 (Severe).


Enrollment: 52
Study Start Date: October 2007
Study Completion Date: December 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: Pancrelipase delayed release capsule
24,000 unit capsule
Placebo Comparator: B Drug: Placebo Comparator
Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414908

  Show 30 Study Locations
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Gregor Eibes, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00414908     History of Changes
Other Study ID Numbers: S245.3.124, 2004-000227-15
Study First Received: December 21, 2006
Results First Received: August 7, 2009
Last Updated: August 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Chronic Pancreatitis
Pancreatectomy
Pancreatic Exocrine Insufficiency

Additional relevant MeSH terms:
Exocrine Pancreatic Insufficiency
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014