Gastrectomy Study: Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy

This study has been completed.

First Received on September 9, 2005. Last Updated on March 28, 2008 History of Changes

Sponsor:	Solvay Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00160186

Purpose

The purpose of this study is to investigate BMI and the nutritional parameters of Creon (pancreatin) versus placebo after a total or subtotal gastrectomy.

Condition	Intervention	Phase
Gastrectomy	Drug: Pancreatin Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Double-Blind, Multicenter, Randomized, Placebo-Controlled, Parallel-Group Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy

Resource links provided by NLM:

Drug Information available for: Pancreatin

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:

Baseline-adjusted body mass index (BMI) after 6 months therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect on body composition, on stool fat, on the coefficient of fat absorption, stool weight, quality of life (Qol), clinical symptoms (gastrointestinal), data from the diary, Elastase [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2003
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Pancreatin 2 capsules Pancreatin with 25 000 lipase units per main meal (3 meals) and 1 capsule per snack (2-3 snacks)
Placebo Comparator: 2	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed consent
Males or females
Age >= 18 years
Total or subtotal gastrectomy
Females having negative pregnancy test or being surgically sterile or 1 year postmenopausal; women of childbearing age must use effective birth control.

Exclusion Criteria:

Diseases or conditions limiting the participation in, or completion of, the study
Progressive tumors/metastasis
Complications leading to insufficient peroral nutrition
Known allergy to pancreatin
Known exocrine insufficiency
Experimental drug intake

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00160186

Locations

Denmark
Site 9
Odense, Denmark
Finland
Site 10
Tampere, Finland
Norway
Site 1
Bergen, Norway
Site 2
Frederikstad, Norway
Site 3
Tromso, Norway
Sweden
Site 5
Linköping, Sweden
Site 7
Malmo, Sweden
Site 6
Stockholm, Sweden
Site 8
Stockholm, Sweden

Sponsors and Collaborators

Solvay Pharmaceuticals

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Responsible Party:	Gregor Eibes, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00160186 History of Changes
Other Study ID Numbers:	S245.4.007
Study First Received:	September 9, 2005
Last Updated:	March 28, 2008
Health Authority:	Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:

Pancreatin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012