Efficacy and Safety of Synera in Osteoarthritis Pain

This study has been completed.
Sponsor:
Collaborator:
Nuvo Research Inc.
Information provided by (Responsible Party):
Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier:
NCT01654302
First received: July 11, 2012
Last updated: April 22, 2015
Last verified: April 2015
Results First Received: September 29, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Knee Osteoarthritis
Interventions: Drug: Synera
Drug: Inactive patch

  Participant Flow
  Hide 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
  Description
Synera Then Placebo Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch at the Second Intervention (Day 7).
Placebo Then Synera Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).

Participant Flow for 2 periods

Period 1:   First Intervention (Day 1)
    Synera Then Placebo     Placebo Then Synera  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  

Period 2:   Second Intervention (Day 7)
    Synera Then Placebo     Placebo Then Synera  
STARTED     20     20  
COMPLETED     19     19  
NOT COMPLETED     1     1  
Lost to Follow-up                 1                 1  



  Baseline Characteristics
  Hide 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.
Baseline analysis performed for participants that completed study.

Reporting Groups
  Description
Synera Then Placebo Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch (placebo) at the Second Intervention (Day 7).
Placebo Then Synera Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
Total Total of all reporting groups

Baseline Measures
    Synera Then Placebo     Placebo Then Synera     Total  
Number of Participants  
[units: participants]
  19     19     38  
Age  
[units: years]
Mean (Standard Deviation)
  57  (7.01)     60  (8.26)     58  (7.77)  
Gender  
[units: participants]
     
Female     8     15     23  
Male     11     4     15  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     15     14     29  
White     4     5     9  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     19     19     38  
Baseline Index Knee Pain Scores [1]
[units: units on a scale]
Mean (Standard Deviation)
  5.90  (1.25)     6.26  (1.37)     6.08  (1.33)  
[1] Subject average baseline index knee pain scores are reported prior to intervention for each group - Synera then Placebo and Placebo then Synera. Index knee pain was reported using the Numeric Rating Scale, a scale from 0 to 10 where 0 = no pain and 10 = the worst pain possible.



  Outcome Measures

1.  Primary:   Index Knee Pain Scores on a Numeric Rating Scale (NRS)   [ Time Frame: 5 minutes after stopped exercise, performed 1 hour after intervention (patch application) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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: Julia Marks, CRC
Organization: Northwestern University
phone: 312-503-1215
e-mail: julia.marks@northwestern.edu


No publications provided


Responsible Party: Thomas J. Schnitzer, Northwestern University
ClinicalTrials.gov Identifier: NCT01654302     History of Changes
Other Study ID Numbers: STU00061115
Study First Received: July 11, 2012
Results First Received: September 29, 2014
Last Updated: April 22, 2015
Health Authority: United States: Food and Drug Administration