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临床试验/DRKS00000342
DRKS00000342已完成3 期

Monocentric, randomised, double-blind, placebo-controlled pilot study in double-dummy design in overweight or obese patientsto compare two treatment regimes (Polyglucosamine L112 vs. Orlistat 60 mg).

Certmedica International GmbH0 个研究点目标入组 26 人开始时间: 2010年2月24日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
26

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
21 Years 至 60 Years(—)
性别
All

入选标准

  • •Overweight with a BMI > 28
  • •Women: waist circumference > 80 cm
  • •Men: waist circumference > 94 cm

排除标准

  • •Pregnancy or breast-feeding
  • •Alcohol-, medication- or drugdependency
  • •Unability to fulfil the criteria of the trial protocol
  • •Cancer, malignoma
  • •Known hypersensivity against crustaceans or one of the excipients
  • •Existing chronic, intestinal diseases, like a required treatment because of an constipation
  • •After intestinal surgery
  • •Diabetes mellitus
  • •Chronic malabsorption syndrome
  • •Cholestasis
  • •Concomitant treatment with cyclosporines, warfarin or other anticoagulants
  • •Liver-malfunctions with transaminases two times above ULN and/or
  • •kidney-malfunctions according a cratinine-clearance above 80ml/min/1.73m²
  • •Taken steroidhormones, could be reduced in their effect
  • •Co-medication: concomitant treatment with
  • •- cyclosporines
  • •- warfarin or other oral anticoagulants
  • •- beta-blocker
  • •- neuroleptica and
  • •- antidepressants is an exclusion criteria.

研究者

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