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Comparison of OPAQUESOL (Shahid Ghazi) and OMNIPAQUE in CT-Scan with contrast

Image contrast quality and safety comparison of OPAQUESOL (Shahid Ghazi) and OMNIPAQUE in CT-Scan with contrast

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201604094920N7
Enrollment
50
Registered
2016-05-09
Start date
2016-06-01
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients candidat for CT-Scan by contrast media. Other and unspecified disorders of circulatory system

Interventions

Intervention 1: Intervention: Patients in this group based on randomization will receive a single dose Opaquesol of Shahid Ghazi with dosage of 300 mg. Intervention 2: Control: Patients in this group
Diagnosis
Intervention: Patients in this group based on randomization will receive a single dose Opaquesol of Shahid Ghazi with dosage of 300 mg.
Control: Patients in this group based on randomization will receive a single dose Omnipaque with dosage of 300 mg.

Sponsors

Shahid Ghazi Pharmaceutical Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Image quality. Timepoint: after CT-Scan. Method of measurement: 1 to 10 scoring by investigator.

Secondary

MeasureTime frame
Renal Toxicity. Timepoint: Before and 72 hours after injection. Method of measurement: Serum creatinine.;Adverse events of contrast media. Timepoint: During injection, 4 and 72 hours after injection. Method of measurement: Interviewing with patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Ramin Heshmat

Head of Chronic Diseases Research Center

sanaeimaryam@yahoo.com+98 21 8835 4309

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026