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

NCT ID: NCT02946450

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Brief Summary

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

Detailed Description

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Conditions

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CT Scanning Patients

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Not applicable-observational study

Not applicable-observational study

Other: Not applicable-observational study

Intervention Type DRUG

Interventions

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Other: Not applicable-observational study

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asan medical center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Ahn, MD, PhD

Role: primary

Other Identifiers

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DW_IOH001

Identifier Type: -

Identifier Source: org_study_id