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ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
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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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 |
| |||
| Study Arms ICMJE |
| |||
| 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 | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||