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: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2009

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

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

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

Lead Sponsor: Solvay Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Global Clinical Director Solvay Study Director Solvay Pharmaceuticals  

Overall Contact: Gregor Eibes  gregor.eibes@solvay.com

Information obtained from ClinicalTrials.gov on July 02, 2009

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