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Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xenon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00954356
First received: July 22, 2009
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
Results First Received: January 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dental Pain
Interventions: Drug: XPF-001
Drug: placebo

  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
All 61 subjects were recruited at a single center between September 29th and November 16th 2009.

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
XPF-001 500 mg XEN402 (5x 100 mg capsules) administered as a single dose
Placebo 5 x matching placebo capsules (administered as a single dose)

Participant Flow:   Overall Study
    XPF-001     Placebo  
STARTED     41     20  
COMPLETED     41     20  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
XPF-001 500 mg XEN402 (5x 100 mg capsules) administered as a single dose
Placebo 5 x matching placebo capsules (administered as a single dose)
Total Total of all reporting groups

Baseline Measures
    XPF-001     Placebo     Total  
Number of Participants  
[units: participants]
 		  41     20     61  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     41     20     61  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  20.2  ± 2.94     20.9  ± 3.01     20.4  ± 2.96  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     41     20     61  
Region of Enrollment  
[units: participants]
 		     
United States     41     20     61  



  Outcome Measures
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1.  Primary:   Total Pain Relief at 6 Hours Post Dose (TOTPAR 6)   [ Time Frame: 6 hours post dose ]
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2.  Secondary:   Total Pain Relief (TOTPAR) at 4 Hours Post Dose   [ Time Frame: 4 hours ]
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3.  Secondary:   Total Pain Relief (TOTPAR) at 8 Hours Post Dose   [ Time Frame: 8 hours ]
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Measure Type Secondary
Measure Title Total Pain Relief (TOTPAR) at 8 Hours Post Dose
Measure Description

A secondary efficacy variable was total pain relief at the 8-hour observation (TOTPAR 8); TOTPAR 8 is an area calculation incorporating time and relief scores over the 8 hours following dosing and was calculated using Simpson's trapezoidal rule.

The higher the LS Means scores, the more pain relief was obtained.

Relief (REL) scores were measured at multiple timepoints after dosing, using a 5 point categorical pain relief rating scale. (None = 0, A Little Relief = 1, Some = 2, A Lot = 3, Complete Relief = 4). The minimum possible TOTPAR 8 score = 0, maximum possible score = 32
Time Frame 8 hours  
Safety Issue No  

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
Placebo Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
XPF-001 Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.

Measured Values
    Placebo     XPF-001  
Number of Participants Analyzed  
[units: participants]
 		  20     41  
Total Pain Relief (TOTPAR) at 8 Hours Post Dose  
[units: units on a scale]
Least Squares Mean ( 95% Confidence Interval ) 		  3.43  
  ( 0.126 to 6.73 )   		  6.41  
  ( 4.11 to 8.71 )  

No statistical analysis provided for Total Pain Relief (TOTPAR) at 8 Hours Post Dose



4.  Secondary:   Total Pain Relief (TOTPAR) at 12 Hours Post Dose   [ Time Frame: 12 hours ]
  Show Outcome Measure 4

5.  Secondary:   Summed Pain Intensity Difference (SPID) at 4 Hours Post Dose   [ Time Frame: Baseline to 4 hours post dose ]
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6.  Secondary:   Summed Pain Intensity Difference (SPID) at 6 Hours Post Dose   [ Time Frame: Baseline to 6 hours post dose ]
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7.  Secondary:   Summed Pain Intensity Difference (SPID) at 8 Hours Post Dose   [ Time Frame: Baseline to 8 hours post dose ]
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8.  Secondary:   Summed Pain Intensity Difference (SPID) at 12 Hours Post Dose   [ Time Frame: Baseline to 12 hours post dose ]
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9.  Secondary:   Time to First Perceptible Relief   [ Time Frame: 24 hours ]
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10.  Secondary:   Time to Meaningful Relief   [ Time Frame: 24 hours ]
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11.  Secondary:   Time to Rescue Medication   [ Time Frame: 24 hours ]
  Show Outcome Measure 11

12.  Secondary:   Treatment Emergent Adverse Events   [ Time Frame: 48 hours ]
  Show Outcome Measure 12


  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:
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 Other disclosure agreement that restricts the right of the PI 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
This model is best suited for drugs with rapid onset of action (e.g. NSAIDs). XPF-001 does not have a rapid onset.  


Results Point of Contact:  
Name/Title: Vice President Clinical
Organization: Xenon Pharmaceuticals Inc.
phone: 6044843300
e-mail: pgoldberg@xenon-pharma.com


No publications provided


Responsible Party: Xenon Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00954356     History of Changes
Other Study ID Numbers: XPF-001-201
Study First Received: July 22, 2009
Results First Received: January 31, 2012
Last Updated: July 10, 2012
Health Authority: United States: Food and Drug Administration