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OpenTrials
Completed

NCT Number: NCT00160186

Gastrectomy Study: 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.

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Key information

Conditions

Gastrectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Site 9, Odense, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pancreatin

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. Baseline-adjusted body mass index (BMI) after 6 months therapy

    Time frame: 6 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Mar 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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