Sugammadex Hypersensitivity Study (Study P06042)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00988065

First received: September 30, 2009

Last updated: July 16, 2012

Last verified: June 2012

History of Changes

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
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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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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 ]

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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 ]

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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 ]

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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 ]

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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. ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Investigator may not publish/publicly present interim results without prior consent of Sponsor. Any materials that report results of the study must be sent to Sponsor 45 days prior to submission for publication/presentation. Sponsor has right to review and comment. In case of any disagreements concerning appropriateness of the materials, investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues or disagreement, prior to submission for publication/presentation.

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

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
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:	July 16, 2012
Health Authority:	United States: Food and Drug Administration

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