NCT02946450

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

October 25, 2016

Last Update Submit

October 25, 2016

Conditions

CT Scanning Patients

Outcome Measures

Primary Outcomes (1)

  • adverse events, adverse drug reaction, serious adverse events, serious drug reaction, laboratory data, vital signs

    14 days

Study Arms (1)

Not applicable-observational study

Not applicable-observational study

Drug: Other: Not applicable-observational study

Interventions

Other: Not applicable-observational studyDRUG
Not applicable-observational study

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

CT scanning patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan medical center

Seoul, 138-736, South Korea

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2016

First Posted

October 27, 2016

Study Start

March 1, 2014

Primary Completion

December 1, 2016

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)