Completed
Evaluation of Experimental and Commercial Air-Activated, Adhesive Backed Heat Patches
What is being tested
Marketed Thermal Adhesive Patch
+ Thermal Adhesive Patch
+ Placebo Patch
Device
Who is being recruted
From 18 to 70 Years
+30 Eligibility Criteria
How is the trial designed
Other Study
Placebo-Controlled
Interventional
Study Start: October 2012
Summary
Principal SponsorChattem, Inc.
Last updated: March 17, 2017
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.To assess the safety and tolerability for the extended wear of an experimental air-activated self adhesive patch.
Principal SponsorChattem, Inc.
Last updated: March 17, 2017
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
157 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
12 inclusion criteria required to participate
Participants are 18 to 70 years of age
Participants are willing to come in each day with a CLEAN back
Participants assigned to the thermocouples must be willing to restrict their activity for the 8 hour patch wear time so that the thermocouples do not come loose
Participants assigned to the thermocouples must be willing to wear a pouch containing the thermostat and thermocouple wiring for the entire 8 hour period and to return all study supplies to the site at visit 15. If the items are not returned subject may be invoiced for the value of the unit
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18 exclusion criteria prevent from participating
Participants unable to tolerate conditions of protocol
Participants viewed by the investigator as not being suitable for the study
Participants who are currently participating in another clinical trial
Participants who are pregnant or nursing, oral interview only
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup of subjects wearing comparative predicate device for 8 hours daily for 7 days.
Group II
ExperimentalGroup of subjects wearing the experimental patch for 8 hours daily for 7 days.
Group III
PlaceboGroup of subjects wearing the placebo patch for 8 hours daily for 7 days.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center