- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01629719
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
June 27, 2012 updated by: Alko Do Brasil Industria e Comercio Ltda
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.
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).
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
73
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Men and women over 18 years.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Study Registration Dates
First Submitted
June 26, 2012
First Submitted That Met QC Criteria
June 27, 2012
First Posted (Estimate)
June 28, 2012
Study Record Updates
Last Update Posted (Estimate)
June 28, 2012
Last Update Submitted That Met QC Criteria
June 27, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- ALK 002-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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