Sugammadex Hypersensitivity Study (Study P06042)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00988065
First received: September 30, 2009
Last updated: April 25, 2014
Last verified: April 2014
Results First Received: April 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypersensitivity
Interventions: Drug: Placebo run-in dose
Drug: Sugammadex 4 mg/kg
Drug: Sugammadex 16 mg/kg
Drug: Placebo

  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
A total of 480 participants received a single-blind placebo dose 7 days prior to randomization. Of these 480 participants, 448 were randomized to double-blind treatment.

Reporting Groups
  Description
Sugammadex 4 mg/kg Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
Sugammadex 16 mg/kg Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
Placebo Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.

Participant Flow:   Overall Study
    Sugammadex 4 mg/kg     Sugammadex 16 mg/kg     Placebo  
STARTED     148 [1]   150 [1]   150 [1]
Received First Randomized Dose     148     150     150  
Received Second Randomized Dose     139     135     145  
Received Third Randomized Dose     135     127     135  
COMPLETED     135     127     135  
NOT COMPLETED     13     23     15  
Adverse Event                 4                 10                 2  
Lost to Follow-up                 1                 2                 2  
Subject withdrew consent                 3                 5                 2  
Noncompliance with protocol                 5                 6                 9  
[1] Randomized to double-blind treatment



  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 4 mg/kg Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
Sugammadex 16 mg/kg Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
Placebo Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
Total Total of all reporting groups

Baseline Measures
    Sugammadex 4 mg/kg     Sugammadex 16 mg/kg     Placebo     Total  
Number of Participants  
[units: participants]
  148     150     150     448  
Age  
[units: years]
Mean ± Standard Deviation
  34.4  ± 10.6     33.2  ± 10.2     33.8  ± 10.8     33.8  ± 10.5  
Gender  
[units: participants]
       
Female     70     73     75     218  
Male     78     77     75     230  



  Outcome Measures
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1.  Primary:   The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms, for Each Sugammadex Dose Group and Placebo.   [ Time Frame: Day 8, Day 36, and Day 78 of the study ]

2.  Secondary:   The Percentage of Participants With Adjudicated Anaphylaxis According to the Definition by Sampson et al., for Each Sugammadex Dose Group and Placebo.   [ Time Frame: Day 8, Day 36, and Day 78 of the study ]

3.  Secondary:   The Percentage of Participants With Each of the 3 Levels of Diagnostic Certainty of Adjudicated Anaphylaxis According to the Definition by Rüggeberg et al., for Each Sugammadex Dose Group and Placebo.   [ Time Frame: Day 8, Day 36, and Day 78 of the study ]

4.  Secondary:   The Percentage of Participants With Adjudicated Hypersensitivity Signs/Symptoms After Each Randomized Dose of Study Treatment, for Each Sugammadex Dose Group and Placebo.   [ Time Frame: Day 8, Day 36, and Day 78 of the study ]

5.  Other Pre-specified:   Percentage of Participants With an Adverse Event Suggestive of a Dose-dependent Trend That Also Exceeds a Frequency Threshold Above 5% in Any Treatment Arm (Including Both Serious and Non-serious Adverse Events).   [ Time Frame: From first randomized dose (Day 8) up to 30 days after day of last randomized dose of study medication. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Results from this study in healthy/conscious subjects may not be fully applicable to anesthetized patient settings.


  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.


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: NCT00988065     History of Changes
Other Study ID Numbers: P06042, EUDRACT: 2009-012014-40
Study First Received: September 30, 2009
Results First Received: April 13, 2011
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration