Dose Finding Posterolateral Thoracotomy Study

This study has been terminated.
(Sponsor decision unrelated to safety)
Sponsor:
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT00807209
First received: December 9, 2008
Last updated: April 15, 2012
Last verified: November 2011
Results First Received: November 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Postoperative Pain
Interventions: Drug: Low Dose SKY0402
Drug: High Dose SKY0402
Drug: Placebo
Drug: Fentanyl via PCA
Drug: Bupivacaine via epidural

  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
No text entered.

Reporting Groups
  Description
High Dose SKY0402 No text entered.
Standard of Care No text entered.
Low Dose SKY0402 No text entered.

Participant Flow:   Overall Study
    High Dose SKY0402     Standard of Care     Low Dose SKY0402  
STARTED     1     1     1  
COMPLETED     1     1     1  
NOT COMPLETED     0     0     0  



  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.
No text entered.

Reporting Groups
  Description
High Dose SKY0402 No text entered.
Standard of Care No text entered.
Low Dose SKY0402 No text entered.
Total Total of all reporting groups

Baseline Measures
    High Dose SKY0402     Standard of Care     Low Dose SKY0402     Total  
Number of Participants  
[units: participants]
  1     1     1     3  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     0     0     1     1  
>=65 years     1     1     0     2  
Age  
[units: years]
Mean ± Standard Deviation
  81  ± 0     75  ± 0     64  ± 0     73.3  ± 0  
Gender  
[units: participants]
       
Female     0     1     1     2  
Male     1     0     0     1  
Region of Enrollment  
[units: participants]
       
United States     1     1     1     3  



  Outcome Measures

1.  Primary:   Amount of Rescue PCA Fentanyl Administered for Breakthrough Pain During the First 72 Hours.   [ Time Frame: 72 hours ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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
The study was terminated early due to Sponsor's decision, unrelated to safety. As there was only one patient in each group, no efficacy analyses were performed.  


Results Point of Contact:  
Name/Title: Executive Medical Director
Organization: Pacira Pharmaceuticals, Inc.
phone: 203-837-6500
e-mail: ErolOnel@pacira.com


No publications provided


Responsible Party: Pacira Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT00807209     History of Changes
Other Study ID Numbers: SKY0402C211
Study First Received: December 9, 2008
Results First Received: November 29, 2011
Last Updated: April 15, 2012
Health Authority: United States: Food and Drug Administration