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

Verified by: Solvay Pharmaceuticals, August 2011
First Received: December 21, 2006 | Last Updated: August 8, 2011 | Phase: Phase 3 | Start Date: October 2007
Overall Status: Completed | Estimated Enrollment: 52
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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...

Brief Summary

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”

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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

  • Drug: Pancrelipase delayed release capsule
    • 24,000 unit capsule
  • Drug: Placebo Comparator
    • Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: A
  • Placebo Comparator: B

Outcome Measures for this Clinical Trial

Primary 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)
      Safety Issue?: No

Secondary 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)
      Safety Issue?: No
  • 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)
      Safety Issue?: No
  • 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)
      Safety Issue?: No
  • Change of Stool Frequency Between Baseline and End of Double-blind (DB) Period
    • Time Frame: End of double-period (5-7 days)
      Safety Issue?: No
  • Abdominal Pain at the End of the Double-blind Period.
    • Time Frame: End of double-period (5-7 days)
      Safety Issue?: No
  • Stool Consistency at the End of the Double-blind Period
    • Time Frame: End of double-period (5-7 days)
      Safety Issue?: No
  • Flatulence at the End of Double-blind Period
    • Time Frame: End of double-period (5-7 days)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Solvay Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00414908

Study ID Number: S245.3.124

ClinicalTrials.gov Identifier: NCT00414908

Health Authority: United States: Food and Drug Administration

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