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

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ClinicalTrials.gov Identifier: NCT00160186
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 31, 2008
Sponsor:
Information provided by:
Solvay Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Gastrectomy Drug: Pancreatin Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2003
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Baseline-adjusted body mass index (BMI) after 6 months therapy [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Gregor Eibes, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00160186     History of Changes
Other Study ID Numbers: S245.4.007
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: March 2008

Additional relevant MeSH terms:
Pancreatin
Pancrelipase
Gastrointestinal Agents