PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination

Diagnostic Imaging Clinical Trial

— IMAGE  

Official title:

Post-marketing Surveillance Study Ultravist®-IMAGE IoproMide (UltrAvist®) to Gain Further Information on Tolerability and Safety in X-ray Examination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876083
• Other study ID #: 14692
• Secondary ID: UV07011342213421
• Status: Completed
• Phase: N/A
• First received: April 3, 2009
• Last updated: February 25, 2011
• Start date: March 2008
• Est. completion date: September 2009

Study information

• Verified date: February 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bosnia and Herzegovina: Food and Drug AdministrtionChina: Ethics CommitteeGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIndonesia: National Agency of Drug and Food ControlIran: Ethics CommitteeItaly: Ethics CommitteeSouth Korea: Korea Food and Drug Administration (KFDA)Moldova: National Ethics CommitteeMalaysia: Medical Research Ethics Committee (MREC)Malaysia: Ministry of HealthPhilippines: Bureau of Food and DrugsPhilippines: Department of HealthPakistan: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: Natioanl Ethics CommitteeRussia: Ethics CommitteeRussia: Ministry of Health of the Russian FederationSingapore: Domain Specific Review BoardsSingapore: Health Sciences AuthorityThailand: Ethical CommitteeTaiwan: Institutional Review BoardUkraine: Central Ethical ComissionVietnam: Central Ethical Comission
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use.The radiologist will administer the contrast medium to the patient as he/she would have done without the study. No other examinations will be performed than would have been done routinely.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44920
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.

Exclusion Criteria:

• No exclusion criteria besides the contraindications for the use of Ultravist as mentioned in the product information.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diagnostic Imaging

Intervention

Drug:
• Ultravist (Iopromide, BAY86-4877)
Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Bosnia and Herzegovina,  China,  Germany,  Hungary,  Indonesia,  Iran, Islamic Republic of,  Italy,  Korea, Republic of,  Malaysia,  Moldova, Republic of,  Pakistan,  Philippines,  Poland,  Romania,  Russian Federation,  Saudi Arabia,  Singapore,  Taiwan,  Thailand,  Ukraine,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events		During and after Ultravist application on the day of examination	Yes
Secondary	General contrast quality in the region of interest as assessed by physicians		On the day of examination	No

External Links

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