An Open-Label Functionality, Safety and Efficacy Study in Patients Undergoing Elective Unilateral Knee Replacement

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AcelRx Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00859313

First received: March 9, 2009

Last updated: February 28, 2012

Last verified: February 2012

History of Changes

Results First Received: January 25, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Pain, Postoperative
Intervention:	Drug: Sufentanil NanoTab PCA System/15 mcg

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
Sufentanil NanoTab PCA System/15 Mcg	15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours

Participant Flow: Overall Study

	Sufentanil NanoTab PCA System/15 Mcg
STARTED	30
COMPLETED	26
NOT COMPLETED	4
Lack of Efficacy	2
Adverse Event	1
staff error	1

Baseline Characteristics

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Outcome Measures

1. Primary:

Percent of Patients Without Device Failure [ Time Frame: 12 hours ]

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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: no publication without prior written consent

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: Dr. Pamela Palmer
Organization: AcelRx Pharmaceuticals, Inc.
phone: 650-216-3504
e-mail: ppalmer@acelrx.com

No publications provided

Responsible Party:	AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00859313 History of Changes
Other Study ID Numbers:	ARX-C-004
Study First Received:	March 9, 2009
Results First Received:	January 25, 2012
Last Updated:	February 28, 2012
Health Authority:	United States: Food and Drug Administration

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