A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01539538
First received: February 22, 2012
Last updated: February 10, 2014
Last verified: February 2014
Results First Received: November 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Post-Operative Pain
Interventions: Drug: Sufentanil NanoTab PCA System/15 mcg
Drug: morphine IV PCA

  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 No text entered.
Morphine IV PCA No text entered.

Participant Flow:   Overall Study
    Sufentanil NanoTab PCA System/15 mcg     Morphine IV PCA  
STARTED     177     180  
COMPLETED     146     136  
NOT COMPLETED     31     44  
Adverse Event                 13                 18  
Lack of Efficacy                 13                 16  
Withdrawal by Subject                 2                 3  
PCA no longer required or PCA problem                 3                 7  



  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 No text entered.
Morphine IV PCA No text entered.
Total Total of all reporting groups

Baseline Measures
    Sufentanil NanoTab PCA System/15 mcg     Morphine IV PCA     Total  
Number of Participants  
[units: participants]
  177     180     357  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     85     85     170  
>=65 years     92     95     187  
Age  
[units: years]
Mean ± Standard Deviation
  64  ± 12.1     64  ± 12.6     64  ± 12.4  
Gender  
[units: participants]
     
Female     123     108     231  
Male     54     72     126  
Region of Enrollment  
[units: participants]
     
United States     177     180     357  



  Outcome Measures

1.  Primary:   Patient Global Satisfaction   [ Time Frame: 48 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: Pamela Palmer
Organization: AcelRx
phone: 650-216-3500
e-mail: ppalmer@acelrx.com


No publications provided


Responsible Party: AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01539538     History of Changes
Other Study ID Numbers: IAP309
Study First Received: February 22, 2012
Results First Received: November 25, 2013
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration