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Study Phase III Comparison of Superiority, Open With Blind Appraiser, to Evaluate the Efficacy and Safety of Barium Sulphate 66.7% With V (OPTI-BAR) Compared to Proceedings in Inert Radiological Examinations for the Diagnosis of Diseases for Image the Tratogastrointstinal

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ClinicalTrials.gov Identifier: NCT01629719
Recruitment Status : Unknown
Verified June 2012 by Alko Do Brasil Industria e Comercio Ltda.
Recruitment status was:  Not yet recruiting
First Posted : June 28, 2012
Last Update Posted : June 28, 2012
Sponsor:
Information provided by (Responsible Party):
Alko Do Brasil Industria e Comercio Ltda

Brief Summary:
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).

Condition or disease
X-ray Examinations of the Gastrointestinal Tract

Study Type : Observational
Estimated Enrollment : 73 participants
Time Perspective: Prospective
Official Title: 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.
Study Start Date : June 2012

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Men and women over 18 years.
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Responsible Party: Alko Do Brasil Industria e Comercio Ltda
ClinicalTrials.gov Identifier: NCT01629719     History of Changes
Other Study ID Numbers: ALK 002-001
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012