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
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Alko Do Brasil Industria e Comercio Ltda.
Recruitment status was Not yet recruiting
Information provided by (Responsible Party):
Alko Do Brasil Industria e Comercio Ltda
First received: June 26, 2012
Last updated: June 27, 2012
Last verified: June 2012
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).
X-ray Examinations of the Gastrointestinal Tract
||Time Perspective: Prospective
||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.
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Men and women over 18 years.
- 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).
- 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.
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ClinicalTrials.gov processed this record on July 26, 2014
||Alko Do Brasil Industria e Comercio Ltda
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 26, 2012
||June 27, 2012
||Brazil: National Agency of Sanitary Vigilance