CT Scanning PatientsNCT02946450
Observational Study to Assess the Safety of Omnipure® Inj.(Iohexol) Contrast Media in CT Scanning Patients
An observational study of CT Scanning Patients, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to assess safety of Omnipure inj. (lohexol) contrast media in CT scanning patients Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- CT Scanning Patients
- What is being tested?
- Other: Not applicable-observational study
- How many people
- 3,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Dec 2016
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CT scanning patients
Who may be able to join
- subjects in need of CT scanning
- subjects who signed up informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan medical center
Seoul, 138-736
Ahn, MD, PhD, shj@daewoong.co.kr
About this study
Official title: Multi-center, Prospective, Non-interventional, Observational Study to Assess the Safety of Omnipure® Inj.(Iohexol) Contrast Media in CT Scanning Patients
The purpose of this study is to assess safety of Omnipure inj. (lohexol) contrast media in CT scanning patients
- Conditions
- CT Scanning Patients
- Being tested
- Other: Not applicable-observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Not applicable-observational studyDrug
| Study group | Role | What they receive |
|---|---|---|
| Not applicable-observational study | Not applicable-observational study Receives: Drug: Other: Not applicable-observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events, adverse drug reaction, serious adverse events, serious drug reaction, laboratory data, vital signs
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startMar 2014
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT Scanning PatientsStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946450
- Sponsor's protocol ID
- DW_IOH001
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 27 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Non-interventional, Observational Study to Assess the Safety of Omnipure® Inj.(Iohexol) Contrast Media in CT Scanning Patients
- ClinicalTrials.gov ID
- NCT02946450
- Acronym / sponsor ID
- DW_IOH001
- Conditions
- CT Scanning Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess safety of Omnipure inj. (lohexol) contrast media in CT scanning patients
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Not applicable-observational study | – | Drug: Other: Not applicable-observational studyNot applicable-observational study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CT scanning patients
Key inclusion criteria (2 listed)
- subjects in need of CT scanning
- subjects who signed up informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other: Not applicable-observational study | Drug | Not applicable-observational study |
Primary outcome
adverse events, adverse drug reaction, serious adverse events, serious drug reaction, laboratory data, vital signs
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CT Scanning Patients, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse events, adverse drug reaction, serious adverse events, serious drug reaction, laboratory data, vital signs (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2016.