Dose Finding Posterolateral Thoracotomy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00807209
Recruitment Status : Terminated (Sponsor decision unrelated to safety)
First Posted : December 11, 2008
Results First Posted : May 15, 2012
Last Update Posted : May 15, 2012
Information provided by (Responsible Party):
Pacira Pharmaceuticals, Inc

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

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
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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 1   1   1   3 
[Units: Participants]
<=18 years   0   0   0   0 
Between 18 and 65 years   0   0   1   1 
>=65 years   1   1   0   2 
[Units: Years]
Mean (Standard Deviation)
 81  (0)   75  (0)   64  (0)   73.3  (0) 
[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

  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.

  More Information

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.

Results Point of Contact:  
Name/Title: Executive Medical Director
Organization: Pacira Pharmaceuticals, Inc.
phone: 203-837-6500

Responsible Party: Pacira Pharmaceuticals, Inc Identifier: NCT00807209     History of Changes
Other Study ID Numbers: SKY0402C211
First Submitted: December 9, 2008
First Posted: December 11, 2008
Results First Submitted: November 29, 2011
Results First Posted: May 15, 2012
Last Update Posted: May 15, 2012