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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
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
No text entered.

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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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.
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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

Baseline Measures
    Sufentanil NanoTab PCA System/15 Mcg  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     19  
Age  
[units: years]
Mean ± Standard Deviation
  65.7  ± 7.4  
Gender  
[units: participants]
 
Female     20  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures

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


  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
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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:
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: 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