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

NCT01629719 | Unknown

• 1 other identifier: ALK 002-001
• Study Type: observational
• Target: 73
• Locations: 0 countries
• Sites: N/A

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).

Conditions

X-ray Examinations of the Gastrointestinal Tract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Men and women over 18 years.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alko Do Brasil Industria e Comercio Ltda: lead

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: June 28, 2012
• Study Start: June 1, 2012
• Last Updated: June 28, 2012

Record last verified: 2012-06