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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
  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 4

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:

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
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013