Creon After Pancreatic Surgery

Verified by: Abbott, August 2011
First Received: September 25, 2007 | Last Updated: August 16, 2011 | Phase: Phase 4 | Start Date: April 2008
Overall Status: Completed | Estimated Enrollment: 58
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This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with...

Brief Summary

Official Title: “One Week Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center Study With Creon® 25000 Minimicrospheres™ in Subjects With Pancreatic Exocrine Insufficiency After Pancreatic Surgery, Followed by an Open-Label Long-Term Extension of 1 Year”

This study will provide efficacy data for Creon 25000 MMS in PS patients as well as long-term safety data. During the long-term treatment with Creon 25000 nutritional parameters will be assessed and correlated with CFA

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: June 2011

Intervention(s) in this Clinical Trial

  • Drug: Creon
    • 3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)
  • Drug: Placebo
    • Placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
  • Placebo Comparator: 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in CFA from baseline to the end of double blind treatment
    • Time Frame: 7 days after baseline
      Safety Issue?: No

Secondary Measures

  • CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology, SF-36, BMI
    • Time Frame: 7 days after baseline, and end of open-label period (1 year of open label treatment)
      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) and
  • Steatorrhoea: stool fat > 15 g/day (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

  • Subjects in an unstable situation (catabolic) after pancreatic surgery
  • Ileus or acute abdomen
  • Current excessive intake of alcohol or drug abuse
  • Hypersensitivity vs porcine proteins / pancreatin
  • Subjects taking digestive enzyme preparations have to stop them before start of the run-in period

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: Abbott Products Industry

Overall Clinical Trial Officials and Contacts

Guenter Krause, MD Study Director Abbott Products  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00535756

Study ID Number: S245.4.008

ClinicalTrials.gov Identifier: NCT00535756

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00535756