Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) With NCT01654354

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Details — Status: Completed

Study information
Verified date	January 2014
Source	Seoul National University Hospital
Contact	n/a
Is FDA regulated	No
Health authority	South Korea: Korea Food and Drug Administration (KFDA)
Study type	Observational [Patient Registry]

Comparison of NEOVIST 370 INJ.(Iopromide 768.86mg) with Ultravist 370 INJ.(Iopromide 768.86mg) in abdominal CT

Recruitment information / eligibility
Status	Completed
Enrollment	104
Est. completion date	December 2013
Est. primary completion date	November 2012
Accepts healthy volunteers	No
Gender	Both
Age group	20 Years to 75 Years
Eligibility	Inclusion Criteria: - Aged 20 to 75 years old. - Subjects who need CT scan - Subjects who are willing to participate in the study and to write the informed consent form. Exclusion Criteria: - Subjects with severe hepatopathy whose AST or ALT = 1,000 IU/L, Subjects with liver cirrhosis whose AST or ALT = UNL(upper normal limit) X 3 - Severe disorder of thyroid gland - homocystinuria - pregnant or breastfeeding female subjects, or female subjects with childbearing potential who are not willing to use proper contraception methods - Participation in another clinical trial within 30days of enrollment into this study.

Observational Model: Case Control, Time Perspective: Prospective

Drug:
• NEOVIST 370 INJ.(Iopromide 768.86mg)

• Ultravist 370 INJ.(Iopromide 768.86mg)

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	imaging quality	Two readers evaluate image quality of the abdomen CT by four-points scale	end of study enrollment	No
Primary	Adverse reaction		immediate after CT scan	Yes
Secondary	SNR (signal to noise ratio) / CNR (contrast to noise ratio)	ROI measurement at abdominal aorta and liver	at the end or enrollment	No