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Heat Wrap Device Safety With Age and Body Fat

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Loma Linda, California, 92350 United States
Contact
1-800-718-1021
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

- 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

NCT01355653
Pfizer
Completed
Heat Wrap Device Safety With Age and Body Fat

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Heat Wrap Device Safety With Age and Body Fat
An Open Label Study To Compare The Effects Of Age And Body Fat On The Safety Of Two Heat Wrap Devices In Healthy Subjects
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.
Safety measurements
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Back Pain
  • 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
  • Experimental: Treatment A
    thermal therapy
    Intervention: Device: thermal therapy
  • Active Comparator: Treatment B
    ThermaCare Lower Back/Hip heatwrap
    Intervention: Device: marketed heatwrap
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
July 2011
July 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 84 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01355653
B3571002
TC-09-12
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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