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

Last updated on November 17, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- The subject is a male or female in generally good health greater or equal to 35 years
of age;

- Female subjects of child-bearing potential and those who are post-menopausal for less
than 2 years must be using a medically-approved method of contraception (i.e., oral,
transdermal, or implanted contraceptive hormones, cervical cap, intrauterine device,
diaphragm, condom, abstinence, or surgical sterility including partner's vasectomy);

- The subject has a waist-hip circumference of between 27-47 inches inclusive.

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

- The subject is a pregnant or lactating woman;

- The subject is diabetic;

- The subject has a history of melanoma, squamous or basal cell carcinoma in the area
of application of the lower back and hip;

- The subject has any active skin disease which may contraindicate participation,
including eczema, rash, broken or irritated skin, contact dermatitis and atopic
dermatitis, or any skin condition that may be aggravated by heat;

- The subject has used (within the previous week) or is using any topical drug or
heatwrap or electrical heat pads at the application site; or

- The subject has damaged skin in, or around the test sites which includes sunburn,
uneven skin tones, tattoos, scars or other disfiguration at the application site,
including an erythema grading of greater than 0 at the application site.

NCT01055262
Pfizer
Completed
Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back

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Descriptive Information
Brief Title  ICMJE Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
Official Title  ICMJE An Open Label Study To Evaluate The Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
Brief SummaryThe objectives of this study are to evaluate the dermal safety and on-body temperature of a disposable heatwrap product when worn while in a supine position for five consecutive days. The product will be worn on the back for approximately 8 hours per 24 hour period.
Detailed DescriptionPurpose-To obtain safety , tolerability and on-body temperature of a heatwrap device for the lower back.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE Device: Heatwrap 1
8 hours continuous topically-applied heat
Study Arms  ICMJE Experimental: Heatwrap 1
Experimental heatwrap device for the lower back
Intervention: Device: Heatwrap 1
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
Actual Enrollment  ICMJE
 (submitted: March 12, 2010)
169
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2010)
165
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion DateFebruary 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The subject is a male or female in generally good health greater or equal to 35 years of age;
  • Female subjects of child-bearing potential and those who are post-menopausal for less than 2 years must be using a medically-approved method of contraception (i.e., oral, transdermal, or implanted contraceptive hormones, cervical cap, intrauterine device, diaphragm, condom, abstinence, or surgical sterility including partner's vasectomy);
  • The subject has a waist-hip circumference of between 27-47 inches inclusive.

Exclusion Criteria:

  • The subject is a pregnant or lactating woman;
  • The subject is diabetic;
  • The subject has a history of melanoma, squamous or basal cell carcinoma in the area of application of the lower back and hip;
  • The subject has any active skin disease which may contraindicate participation, including eczema, rash, broken or irritated skin, contact dermatitis and atopic dermatitis, or any skin condition that may be aggravated by heat;
  • The subject has used (within the previous week) or is using any topical drug or heatwrap or electrical heat pads at the application site; or
  • The subject has damaged skin in, or around the test sites which includes sunburn, uneven skin tones, tattoos, scars or other disfiguration at the application site, including an erythema grading of greater than 0 at the application site.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 35 Years and older   (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 Not Provided
Removed Location CountriesUnited States
 
Administrative Information
NCT Number  ICMJE NCT01055262
Other Study ID Numbers  ICMJE TC-09-06
TC-09-06
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMay 2012

ICMJE     Data element required by the

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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