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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

This study is not yet open for participant recruitment.
Verified June 2012 by Alko Do Brasil Industria e Comercio Ltda
Sponsor:
Information provided by (Responsible Party):
Alko Do Brasil Industria e Comercio Ltda
ClinicalTrials.gov Identifier:
NCT01629719
First received: June 26, 2012
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  Purpose

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
X-ray Examinations of the Gastrointestinal Tract

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

MedlinePlus related topics: X-Rays
U.S. FDA Resources

Further study details as provided by Alko Do Brasil Industria e Comercio Ltda:

Estimated Enrollment: 73
Study Start Date: June 2012
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alko Do Brasil Industria e Comercio Ltda
ClinicalTrials.gov Identifier: NCT01629719     History of Changes
Other Study ID Numbers: ALK 002-001
Study First Received: June 26, 2012
Last Updated: June 27, 2012
Health Authority: Brazil: National Agency of Sanitary Vigilance

ClinicalTrials.gov processed this record on May 23, 2013