Comparison of 2.0 mg/kg Sugammadex and Neostigmine at Reappearance of T2 in Chinese and European Subjects (Study 19.4.324)(P05768AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00825812
First received: January 15, 2009
Last updated: October 24, 2013
Last verified: October 2013
Results First Received: July 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Anesthesia, General
Neuromuscular Blockade
Interventions: Drug: Sugammadex
Drug: neostigmine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
308 participants were randomized

Reporting Groups
  Description
Sugammadex in Caucasian Subjects At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
Neostigmine in Caucasian Subjects At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
Sugammadex in Chinese Subjects At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
Neostigmine in Chinese Subjects At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.

Participant Flow:   Overall Study
    Sugammadex in Caucasian Subjects     Neostigmine in Caucasian Subjects     Sugammadex in Chinese Subjects     Neostigmine in Chinese Subjects  
STARTED     29     32     126     121  
TREATED     29     31     120     111  
COMPLETED     29     31     120     111  
NOT COMPLETED     0     1     6     10  
Never entered follow up                 0                 0                 0                 1  
Adverse Event                 0                 0                 0                 1  
Subject withdrew consent                 0                 0                 3                 2  
Non-compliance with protocol                 0                 0                 0                 1  
Administrative                 0                 1                 3                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugammadex in Caucasian Subjects At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
Neostigmine in Caucasian Subjects At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
Sugammadex in Chinese Subjects At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
Neostigmine in Chinese Subjects At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
Total Total of all reporting groups

Baseline Measures
    Sugammadex in Caucasian Subjects     Neostigmine in Caucasian Subjects     Sugammadex in Chinese Subjects     Neostigmine in Chinese Subjects     Total  
Number of Participants  
[units: participants]
  29     31     120     111     291  
Age  
[units: years]
Mean ( Full Range )
  52.0  
  ( 27 to 64 )  
  51.9  
  ( 34 to 63 )  
  39.9  
  ( 19 to 63 )  
  39.4  
  ( 18 to 61 )  
  42.2  
  ( 18 to 64 )  
Gender  
[units: participants]
         
Female     25     28     78     86     217  
Male     4     3     42     25     74  



  Outcome Measures
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1.  Primary:   Time From Start of Administration of Investigational Medicinal Product (IMP) to Recovery of the T4/T1 Ratio to 0.9.   [ Time Frame: start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade ]

2.  Secondary:   Time From Start of Administration of IMP to Recovery of the T4/T1 Ratio to 0.7 and 0.8.   [ Time Frame: start of administration of sugammadex/neostigmine to recovery from neuromuscular blockade ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00825812     History of Changes
Other Study ID Numbers: P05768, 19.4.324
Study First Received: January 15, 2009
Results First Received: July 22, 2011
Last Updated: October 24, 2013
Health Authority: Denmark: Danish Medicines Agency
China: Food and Drug Administration