A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy

This study has been completed.

Study NCT00231478 Information provided by Hoffmann-La Roche

First Received on September 30, 2005. Last Updated on May 16, 2011 History of Changes

Results First Received: March 30, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Post-Operative Nausea and Vomiting
Intervention:	Drug: granisetron

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
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Reporting Groups

	Description
Granisetron 20 ug/kg	Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
Granisetron 40 ug/kg	Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery

Participant Flow: Overall Study

	Granisetron 20 ug/kg	Granisetron 40 ug/kg
STARTED	87	84
COMPLETED	79	78
NOT COMPLETED	8	6
Protocol Violation	3	2
Refused Treatment	1	1
Withdrawal by Subject	1	0
Adverse Event	0	1
Administrative	3	2

Baseline Characteristics

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Reporting Groups

	Description
Granisetron 20 ug/kg	Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
Granisetron 40 ug/kg	Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery

Baseline Measures

	Granisetron 20 ug/kg	Granisetron 40 ug/kg	Total
Number of Participants [units: participants]	70	73	143
Age ^[1] [units: years] Mean ± Standard Deviation	6.0 ± 3.37	6.2 ± 3.12	6.1 ± 3.24
Gender [units: participants]
Female	22	43	65
Male	48	30	78

[1]	The safety population was all evaluable population. The evaluable population consisted of 143 pediatric subjects from 2 to 16 years.

Outcome Measures

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1. Primary:

Number of Patients With no Vomiting [ Time Frame: 0-2h after end of surgery (time of extubation) ]

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2. Secondary:

Number of Patients With no Vomiting [ Time Frame: 0-24h after time of extubation ]

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3. Secondary:

Time to First Vomiting Episode [ Time Frame: 0-24h after time of extubation ]

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4. Secondary:

Adverse Experiences [ Time Frame: infusion to 15 days post treatment ]

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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: "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights."

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
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Results Point of Contact:

Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590

No publications provided

Responsible Party:	Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00231478 History of Changes
Other Study ID Numbers:	ML16633
Study First Received:	September 30, 2005
Results First Received:	March 30, 2011
Last Updated:	May 16, 2011
Health Authority:	United States: Food and Drug Administration