The purpose of this clinical study is to compare the effects of contrast agent (iohexol) Opacuesol produced by Shahid Ghazi pharmaceutics and Omnipaque (Commercial Brand). This is a phase 3, double-blind clinical trial with random allocation method. The primary outcome will be image quality which be assessed by radiologist. Probable adverse events and renal toxicity will be secondary outcomes of this trial. A total of 50 referred patients for peripheral CT-Scan with contrast in both male and female genders, aged between 45 and 65 years old will be eligible for recruitment in this study. Patients suffering from kidney disfunction and history of allergy to contrasts will be excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604094920N7
Registration date:2016-05-09, 1395/02/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-09, 1395/02/20
Registrant information
Name
Ramin Heshmat
Name of organization / entity
Chronic Diseases Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0086
Email address
rheshmat@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Ghazi Pharmaceutics Company
Expected recruitment start date
2016-06-01, 1395/03/12
Expected recruitment end date
2016-09-29, 1395/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Image contrast quality and safety comparison of OPAQUESOL (Shahid Ghazi) and OMNIPAQUE in CT-Scan with contrast
Public title
Comparison of OPAQUESOL (Shahid Ghazi) and OMNIPAQUE in CT-Scan with contrast
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged between 45 to 65 years old; Referred subjects for CT-Scan by contrast media; Provided signed and dated informed consent subjects.
Exclusion criteria: Patient with contrast administration in the past 7 days; Subjects have known contra-indication and allergy to contrast administration; Renal insufficiency as defined by GFR < 50; Lactation; Pregnancy; Bronchial asthma; Clinical unstable condition (hemodynamic, respiratory, neurologic); Emergency cases; Hyperthyroidism; End-stage patients.
Age
From 45 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
6th Floor, Ghods St, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2016-04-10, 1395/01/22
Ethics committee reference number
IR.TUMS.REC.1395-2341
Health conditions studied
1
Description of health condition studied
patients candidat for CT-Scan by contrast media
ICD-10 code
I99
ICD-10 code description
Other and unspecified disorders of circulatory system
Primary outcomes
1
Description
image quality
Timepoint
after CT-Scan
Method of measurement
1 to 10 scoring by investigator
Secondary outcomes
1
Description
Renal Toxicity
Timepoint
Before and 72 hours after injection
Method of measurement
Serum creatinine
2
Description
Adverse events of contrast media
Timepoint
During injection, 4 and 72 hours after injection
Method of measurement
Interviewing with patient
Intervention groups
1
Description
Intervention: Patients in this group based on randomization will receive a single dose Opaquesol of Shahid Ghazi with dosage of 300 mg.
Category
Diagnosis
2
Description
Control: Patients in this group based on randomization will receive a single dose Omnipaque with dosage of 300 mg.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Radiology, Dr. Shariati Hospital
Full name of responsible person
Dr. AmirPejman Hashemi Taheri
Street address
North Kargar Ave., Jalal-e-Al-e-Ahmad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Ghazi Pharmaceutical Company
Full name of responsible person
Dr. Ramin Radmanesh
Street address
No 3, Norani Blvd, Farahzadi Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Ghazi Pharmaceutical Company
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Head of Chronic Diseases Research Center
Full name of responsible person
Dr.Ramin Heshmat
Position
Ph.D of Epidemiology
Other areas of specialty/work
Street address
No.111, 19th Alley, North Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8835 4309
Fax
Email
sanaeimaryam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Head of Radiology Depaetment
Full name of responsible person
Amir Pejman Hashemi Taheri
Position
MD, Radiologist
Other areas of specialty/work
Street address
Department of Radiology, First floor, Shariati Hospital, Al-e-Ahmad Ave.
City
Tehran
Postal code
Phone
+98 21 8835 4309
Fax
Email
apejmanht@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Chronic Diseases Research Center
Full name of responsible person
Maryam Sanaei
Position
M.Sc of Microbiology
Other areas of specialty/work
Street address
No 111, 19th Alley, North Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 8835 4309
Fax
Email
sanaeimaryam@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)