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

X-ray Examinations of the Gastrointestinal Tract Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01629719
• Other study ID #: ALK 002-001
• Status: Not yet recruiting
• Phase: N/A
• First received: June 26, 2012
• Last updated: June 27, 2012
• Start date: June 2012

Study information

• Verified date: June 2012
• Source: Alko Do Brasil Industria e Comercio Ltda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Agency of Sanitary Vigilance
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 73
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• X-ray Examinations of the Gastrointestinal Tract

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alko Do Brasil Industria e Comercio Ltda