Observational Study to Assess the Safety of Omnipure® Inj... | NCT02946450

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

NCT02946450

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Unknown status

Last Update Posted

Oct 27, 2016Estimated

Enrollment

3,000Estimated

Phase

Not provided

Conditions

CT Scanning Patients

Interventions

Other: Not applicable-observational study

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Dec 2016Estimated

Completion Date

Not provided

First Submitted Date

Oct 25, 2016

First Submission Date that Met QC Criteria

Oct 25, 2016

First Posted Date

Oct 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2016

Last Update Posted Date

Oct 27, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

14 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Not applicable-observational study		Not applicable-observational study	Drug: Other: Not applicable-observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Other: Not applicable-observational study	Drug		Not applicable-observational study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
adverse events, adverse drug reaction, serious adverse events, serious drug reaction, laboratory data, vital signs		14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

CT scanning patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan medical center	Recruiting	Seoul		138-736	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided