Creon After Pancreatic Surgery
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Insufficiency
Intervention: Creon (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
Overall contact:
Gregor Eibes, Email: gregor.eibes@solvay.com
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Change in CFA from baseline to the end of double blind treatment
Secondary outcome: CNA, stool fat, stool weight, nutritional parameters, clinical symptomatology, SF-36, BMI
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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) 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
Locations and Contacts
Gregor Eibes, Email: gregor.eibes@solvay.com
Site 01, Heidelberg, Germany; Recruiting
Site 03, Munich, Germany; Recruiting
Site 04, Greifswald, Germany; Recruiting
Site 05, Hamburg, Germany; Recruiting
Site 02, Verona, Italy; Recruiting
Additional Information
Starting date: January 2008
Ending date: October 2009
Last updated: September 4, 2009
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