Last updated: 11/07/2018 01:19:33

ULTIVA Post Marketing Surveillance

GSK study ID
105936
See study documents
Clinicaltrials.gov ID
NCT01299584
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2010-29-04
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website