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Observational Study to Assess the Safety of Omnipure® Inj.(Iohexol) Contrast Media in CT Scanning Patients

Multi-center, Prospective, Non-interventional, Observational Study to Assess the Safety of Omnipure® Inj.(Iohexol) Contrast Media in CT Scanning Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02946450
Enrollment
3000
Registered
2016-10-27
Start date
2014-03-31
Completion date
Unknown
Last updated
2016-10-27

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

Conditions

CT Scanning Patients

Brief summary

The purpose of this study is to assess safety of Omnipure inj. (lohexol) contrast media in CT scanning patients

Interventions

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* subjects in need of CT scanning * subjects who signed up informed consent

Exclusion criteria

* Known allergy or hypersensitivity to the study medication, ingredient of the medication, and Iodine type medication * severe renal insufficiency patients * severe hypothyroidism * severe local infection or bacteremia

Design outcomes

Primary

MeasureTime frame
adverse events, adverse drug reaction, serious adverse events, serious drug reaction, laboratory data, vital signs14 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026