Text Size

ULTIVA Post Marketing Surveillance

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01299584
First received: February 17, 2011
Last updated: March 24, 2011
Last verified: February 2011
History of Changes
  Purpose

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.


Condition Intervention
Analgesia
 Drug: Remifentanil

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Marketing Surveillance to Monitor the Safety of ULTIVA (Remifentanil) Adminstered in Korean Subjects According to the Prescribing Information

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Participants With an Unexpected Serious Adverse Event [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. An unexpected event is an event that is not listed in the approval product information and is not described as a precaution or warning.


Secondary Outcome Measures:
  • Number of Participants With an Adverse Event [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all AEs occurring during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events" in the Adverse Event section of the results record.

  • Number of Participants With a Serious Adverse Event [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. For a list of all SAEs occurring during the course of the study, see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record.

  • Number of Participants With the Indicated Unexpected Adverse Event [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approval product information and not described as precautions or warnings.


Enrollment: 775
Study Start Date: September 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Remifentanil
Patients administrated remifentanil at the site
 Drug: Remifentanil
Basically there is no treatment allocation. Subjects who would be administered of remifentanil at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The subjects are patients prescribed for Remifentanil by the investigators at the sites based on prescription information in normal clinical practices.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299584

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01299584     History of Changes
Other Study ID Numbers: 105936
Study First Received: February 17, 2011
Results First Received: March 24, 2011
Last Updated: March 24, 2011
Health Authority: Korea: Korea Food & Drug Administration

Additional relevant MeSH terms:
Remifentanil
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on June 18, 2013