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

Phase 4

Completed

• Conditions: Gastrectomy
• Interventions: Drug: Pancreatin; Drug: Placebo

• Registration Number: NCT00160186
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Primary Completion: 2006-05
• Study Completion: 2006-05
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-28
• Last Update Posted: 2008-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pancreatin	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Baseline-adjusted body mass index (BMI) after 6 months therapy	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Site 9; 🇩🇰 Odense, Denmark

Site 10; 🇫🇮 Tampere, Finland

Site 1; 🇳🇴 Bergen, Norway

Site 2; 🇳🇴 Frederikstad, Norway

Site 3; 🇳🇴 Tromso, Norway

Site 5; 🇸🇪 Linköping, Sweden

Site 7; 🇸🇪 Malmo, Sweden

Site 6; 🇸🇪 Stockholm, Sweden

Site 8; 🇸🇪 Stockholm, Sweden