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

Solvay

Status and phase: Completed; Phase 4

Conditions: Gastrectomy

Treatments: Drug: Placebo; Drug: Pancreatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160186

S245.4.007

Details and patient eligibility

About

The purpose of this study is to investigate BMI and the nutritional parameters of Creon (pancreatin) versus placebo after a total or subtotal gastrectomy.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: Pancreatin

2

Placebo Comparator group

Treatment:

Drug: Placebo