Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01055262
First received: January 21, 2010
Last updated: May 7, 2012
Last verified: May 2012
Results First Received: May 7, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Healthy
Intervention: Device: Heatwrap 1

  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
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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
ThermaCare Overnight HeatWrap Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).

Participant Flow:   Overall Study
    ThermaCare Overnight HeatWrap  
STARTED     169  
COMPLETED     160  
NOT COMPLETED     9  
Adverse Event                 5  
Protocol Violation                 3  
Uncooperativeness                 1  



  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
ThermaCare Overnight HeatWrap Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).

Baseline Measures
    ThermaCare Overnight HeatWrap  
Number of Participants  
[units: participants]
  169  
Age  
[units: years]
Mean ( Full Range )
  55.9  
  ( 35.0 to 87.0 )  
Gender  
[units: participants]
 
Female     115  
Male     54  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Significant Skin Event (Day 5 Cumulative)   [ Time Frame: Day 2 to Day 6 ]

2.  Secondary:   Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative)   [ Time Frame: Day 2 to Day 5 ]

3.  Secondary:   Time to First Significant Skin Event   [ Time Frame: Baseline to Day 6 ]

4.  Secondary:   Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative)   [ Time Frame: Day 2 to Day 6 ]

5.  Secondary:   Time to First Report of Non-zero Erythema Score or Elevated Response   [ Time Frame: Baseline to Day 6 ]

6.  Secondary:   Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation   [ Time Frame: Baseline to Day 6 ]

7.  Secondary:   Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day   [ Time Frame: Baseline to Day 6 ]

8.  Secondary:   Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day   [ Time Frame: Baseline to Day 6 ]


  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: Pfizer Clinical Trials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquires@Pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01055262     History of Changes
Other Study ID Numbers: TC-09-06, TC-09-06
Study First Received: January 21, 2010
Results First Received: May 7, 2012
Last Updated: May 7, 2012
Health Authority: United States: Food and Drug Administration