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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

September 9, 2005
March 28, 2008
December 2003
May 2006   (final data collection date for primary outcome measure)
Baseline-adjusted body mass index (BMI) after 6 months therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00160186 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Gastrectomy Study: Study to Investigate the Effect of Creon 25000 Minimicrospheres on Body Mass Index (BMI) in Patients After Gastrectomy
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Gastrectomy
  • 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
  • Experimental: 1
    Intervention: Drug: Pancreatin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
May 2006
May 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland,   Norway,   Sweden
 
NCT00160186
S245.4.007
No
Gregor Eibes, Solvay Pharmaceuticals
Solvay Pharmaceuticals
Not Provided
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
Solvay Pharmaceuticals
March 2008

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