Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00902070

First received: May 13, 2009

Last updated: November 27, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	May 13, 2009
Last Updated Date	November 27, 2012
Start Date ^ICMJE	November 2007
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 13, 2009)	incidence of adverse events [ Time Frame: The standard observation period for a patient is duration of hospital stay (from one week before Eslax administration to one week after administration at a maximum). ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00902070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 13, 2009)	intubation score [ Time Frame: From administration of Eslax to completion of intubation ] [ Designated as safety issue: Yes ] intubation completion time [ Time Frame: From administration of Eslax to completion of intubation ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Protocol for Eslax Intravenous Drug Use Investigation (Study P06082)
Official Title ^ICMJE	Protocol for Eslax Intravenous Drug Use Investigation
Brief Summary	The main purpose of this investigation is to collect safety and efficacy information of Eslax Intravenous 25mg/2.5mL and 50mg/5.0mL (hereinafter referred to as "Eslax") in daily clinical settings.
Detailed Description	Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Japanese 3000 patients
Condition ^ICMJE	Anesthesia
Intervention ^ICMJE	Drug: Rocuronium Normally, for adults, 0.6 mg/kg of rocuronium bromide is intravenously administered to support endotracheal intubation. If additional administration is necessary, 0.1 - 0.2 mg/kg is intravenously administered. In the case of continuous infusion, infusion is initiated at a rate of 7 μg/kg/min. Dosage should be adjusted based on the age or symptom. The upper limit of this drug for the intubation is 0.9 mg/kg. Other Name: Eslax
Study Group/Cohort (s)	1 Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation Intervention: Drug: Rocuronium
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	3969
Completion Date	October 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients to whom Eslax has been administered to relax muscles at the time of anesthesia or tracheal intubation. Exclusion Criteria: Patients with a history of hypersensitivity to Eslax or bromide. Patients with myasthenia gravis or myasthenic syndrome.
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00902070
Other Study ID Numbers ^ICMJE	P06082
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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