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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00160186

Enrollment

Registered

2005-09-12

Start date

2003-12-31

Completion date

2006-05-31

Last updated

2008-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrectomy

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.

Interventions

DRUGPancreatin

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

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Baseline-adjusted body mass index (BMI) after 6 months therapy	6 months

Secondary

Measure	Time frame
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

Countries

Denmark, Finland, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026