Last updated: 11/07/2018 01:19:33
ULTIVA Post Marketing Surveillance
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A Post Marketing Surveillance to monitor the safety of ULTIVA (Remifentanil) adminstered in Korean subjects according to the prescribing information
Trial description: This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of remifentanil in real clinical practices after marketing.The subjects are patients prescribed for remifentanil by the investigators at the sites based on prescription information in normal clinical practices.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with an unexpected serious adverse event
Timeframe: 24 hours
Secondary outcomes:
Number of participants with an adverse event
Timeframe: 24 hours
Number of participants with a serious adverse event
Timeframe: 24 hours
Number of participants with the indicated unexpected adverse event
Timeframe: 24 hours
Interventions:
Drug: Remifentanil
Enrollment:
775
Observational study model:
Cohort
Primary completion date:
2010-29-04
Time perspective:
Prospective
Clinical publications:
Jeong-Youn Bae, Shin-Young Oh MS, Joon-Hyung Kim MD, MS and Dr. Yil-Seob Lee MD, PhD.. A Post-Marketing Surveillance to Monitor the Safety of Remifentanil in Korean Patients. JPERM. 2012;5:123-129.
Medical condition
Analgesia
Product
remifentanil
Collaborators
Not applicable
Study date(s)
September 2005 to April 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Patients requiring general anesthesia
- According to precautions or warnings on PI, remifentanil should not be administered to the following patients
- Patients with any allergic reaction to any ingredients of remifentanil or other fentanyl analogues
Inclusion and exclusion criteria
Inclusion criteria:
- Patients requiring general anesthesia
Exclusion criteria:
- According to precautions or warnings on PI, remifentanil should not be administered to the following patients
- Patients with any allergic reaction to any ingredients of remifentanil or other fentanyl analogues
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2010-29-04
Actual study completion date
2010-29-04
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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