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NCT00160186 Clinical Trial

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

Gastrectomy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00160186
Other study ID # S245.4.007
Secondary ID
Status Completed
Phase Phase 4
First received September 9, 2005
Last updated March 28, 2008
Start date December 2003
Est. completion date May 2006

Study information
Verified date March 2008
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 2006
Est. primary completion date May 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark Site 9 Odense
Finland Site 10 Tampere
Norway Site 1 Bergen
Norway Site 2 Frederikstad
Norway Site 3 Tromso
Sweden Site 5 Linköping
Sweden Site 7 Malmo
Sweden Site 6 Stockholm
Sweden Site 8 Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Baseline-adjusted body mass index (BMI) after 6 months therapy 6 months No
Secondary 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 6 months No
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