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

March 28, 2008 updated by: Solvay Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Baseline-adjusted body mass index (BMI) after 6 months therapy
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

March 31, 2008

Last Update Submitted That Met QC Criteria

March 28, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S245.4.007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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