Heat Wrap Device Safety With Age and Body Fat

NCT01355653

Last updated date
Study Location
Pfizer Investigational Site
Loma Linda, California, 92350, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Back Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-84 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2

- or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or < 30 kg/m2

- Females who are not pregnant or breastfeeding

- Subject is medically cleared for study participation

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- No sensitivity or allergy to device components in contact with skin


- Diabetes


- Any active skin disease or tattoos at the test site that would affect participation

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  45. Charleston, South Carolina
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Advanced Information
Descriptive Information
Brief Title  ICMJE Heat Wrap Device Safety With Age and Body Fat
Official Title  ICMJE An Open Label Study To Compare The Effects Of Age And Body Fat On The Safety Of Two Heat Wrap Devices In Healthy Subjects
Brief Summary This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.
Detailed Description Safety measurements
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Back Pain
Intervention  ICMJE
  • Device: thermal therapy
    heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day
  • Device: marketed heatwrap
    heatwrap, topical, one time application, 8 hour duration
Study Arms  ICMJE
  • Experimental: Treatment A
    thermal therapy
    Intervention: Device: thermal therapy
  • Active Comparator: Treatment B
    ThermaCare Lower Back/Hip heatwrap
    Intervention: Device: marketed heatwrap
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 31, 2011)
57
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ? 30 kg/m2
  • or 55-84 years of age and with a body mass index ? 30 kg/m2 or < 30 kg/m2
  • Females who are not pregnant or breastfeeding
  • Subject is medically cleared for study participation

Exclusion Criteria:

  • No sensitivity or allergy to device components in contact with skin
  • Diabetes
  • Any active skin disease or tattoos at the test site that would affect participation
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01355653
Other Study ID Numbers  ICMJE B3571002
TC-09-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP