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临床试验/NCT01629719
NCT01629719Unknown不适用

STUDY PHASE III COMPARISON OF SUPERIORITY, OPEN WITH BLIND APPRAISER, TO EVALUATE THE EFFICACY AND SAFETY OF BARIUM SULPHATE 66.7% W / V (OPTI-BAR) COMPARED TO PROCEEDINGS IN INERT RADIOLOGICAL EXAMINATIONS FOR THE DIAGNOSIS OF DISEASES FOR IMAGE THE TRATOGASTROINTSTINAL.

Alko Do Brasil Industria e Comercio Ltda0 个研究点目标入组 73 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
73

研究概览

简要总结

Phase III clinical study, two samples, with assessor blind for the purpose of evaluating the efficacy and safety of the superiority of the use of barium sulphate 66.7% w/v (Opti-bar) as a contrast X-ray (X-ray).

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Men and women over 18 who need x-rays gastrointestinal tract with contrast;
  • Healthy patient, ambulatory;
  • Willingness to comply with the requirements of the study after signing an informed consent and (hit).

排除标准

  • Pregnant or lactating women;
  • Patients allergic to barium sulfate, latex rubber or simethicone;
  • Patients who have asthma, eczema, cystic fibrosis, heart disease, high blood pressure, rectal cancer, colostomy, obstruction in the stomach or intestines, pseudotumor cerebri, blocking stomach or intestinal disease, Hirsch or pseudotumor cerebri;
  • Patients who have recently undergone a rectal biopsy or surgery or a recent history of drilling into your esophagus, stomach or intestines; Patients who have already participated in another clinical protocol in the last six months;
  • Other clinical criteria that in the opinion of the study investigator could compromise the welfare of the patient or interfere with the results expected from the study.

研究者

申办方类型
Industry
责任方
Sponsor

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