Creon After Pancreatic Surgery - Full Text View

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00535756

Purpose

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.

Condition	Intervention	Phase
Pancreatic Insufficiency	Drug: Creon Drug: Placebo	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Pancrelipase Ultrase

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Change in CFA from baseline to the end of double blind treatment [ Time Frame: 7 days after baseline ] [ Designated as safety issue: No ]

Secondary Outcome 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) ] [ Designated as safety issue: No ]

Estimated Enrollment:	54
Study Start Date:	January 2008
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Creon 3 capsules Creon with 25000 lipase units per main meal (3 main meals) plus 2 capsules per snack (2-3 snacks)
2: Placebo Comparator	Drug: Placebo 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) 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535756

Contacts

Contact: Gregor Eibes

gregor.eibes@solvay.com

Locations

Germany
Site 01	Recruiting
Heidelberg, Germany
Site 03	Recruiting
Munich, Germany
Site 04	Recruiting
Greifswald, Germany
Site 05	Recruiting
Hamburg, Germany
Hungary
Site 06	Not yet recruiting
Budapest, Hungary
Site 07	Not yet recruiting
Szeged, Hungary
Site 08	Not yet recruiting
Gyula, Hungary
Site 09	Not yet recruiting
Sopron, Hungary
Site 10	Not yet recruiting
Budapest, Hungary
Site 11	Not yet recruiting
Szentes, Hungary
Site 12	Not yet recruiting
Budaors, Hungary
Site 13	Not yet recruiting
Budapest, Hungary
Site 14	Not yet recruiting
Bekescsaba, Hungary
Site 15	Not yet recruiting
Dunaujvaros, Hungary
Italy
Site 02	Recruiting
Verona, Italy

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Solvay Pharmaceuticals ( Gregor Eibes )
Study ID Numbers:	S245.4.008, 2005-004854-29
Study First Received:	September 25, 2007
Last Updated:	January 26, 2010
ClinicalTrials.gov Identifier:	NCT00535756 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Solvay Pharmaceuticals:

Pancreatic Exocrine Insufficiency After Pancreatic Surgery

Additional relevant MeSH terms:

Digestive System Diseases
Therapeutic Uses
Gastrointestinal Agents
Pancreatic Diseases

Pancrelipase
Pharmacologic Actions
Exocrine Pancreatic Insufficiency

ClinicalTrials.gov processed this record on February 08, 2010