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.

Sponsor:

Information provided by:

Solvay Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00160186

First received: September 9, 2005

Last updated: March 28, 2008

Last verified: March 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

March 28, 2008

Start Date ^ICMJE

December 2003

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00160186 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Gastrectomy

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Intervention: Drug: Pancreatin
Placebo Comparator: 2
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2006

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark, Finland, Norway, Sweden

Administrative Information

NCT Number ^ICMJE

NCT00160186

Other Study ID Numbers ^ICMJE

S245.4.007

Has Data Monitoring Committee

Responsible Party

Gregor Eibes, Solvay Pharmaceuticals

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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