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ULTIVA Post Marketing Surveillance

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Analgesia

Intervention: Remifentanil (Drug)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: A Post Marketing Surveillance to Monitor the Safety of ULTIVA (Remifentanil) Adminstered in Korean Subjects According to the Prescribing Information

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Number of Participants With an Unexpected Serious Adverse Event

Secondary outcome:

Number of Participants With an Adverse Event

Number of Participants With a Serious Adverse Event

Number of Participants With the Indicated Unexpected Adverse Event

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: September 2005
Last updated: March 24, 2011

Page last updated: August 23, 2015

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