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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01055262

First received: January 21, 2010

Last updated: May 7, 2012

Last verified: May 2012

History of Changes

Results First Received: May 7, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label
Condition:	Healthy
Intervention:	Device: Heatwrap 1

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
ThermaCare Overnight HeatWrap	Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).

Participant Flow: Overall Study

	ThermaCare Overnight HeatWrap
STARTED	169
COMPLETED	160
NOT COMPLETED	9
Adverse Event	5
Protocol Violation	3
Uncooperativeness	1

Baseline Characteristics

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Reporting Groups

	Description
ThermaCare Overnight HeatWrap	Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).

Baseline Measures

	ThermaCare Overnight HeatWrap
Number of Participants [units: participants]	169
Age [units: years] Mean ( Full Range )	55.9 ( 35.0 to 87.0 )
Gender [units: participants]
Female	115
Male	54

Outcome Measures

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1. Primary:

Percentage of Participants With a Significant Skin Event (Day 5 Cumulative) [ Time Frame: Day 2 to Day 6 ]

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2. Secondary:

Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) [ Time Frame: Day 2 to Day 5 ]

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3. Secondary:

Time to First Significant Skin Event [ Time Frame: Baseline to Day 6 ]

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4. Secondary:

Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) [ Time Frame: Day 2 to Day 6 ]

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5. Secondary:

Time to First Report of Non-zero Erythema Score or Elevated Response [ Time Frame: Baseline to Day 6 ]

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6. Secondary:

Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation [ Time Frame: Baseline to Day 6 ]

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7. Secondary:

Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day [ Time Frame: Baseline to Day 6 ]

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8. Secondary:

Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day [ Time Frame: Baseline to Day 6 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer Clinical Trials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquires@Pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01055262 History of Changes
Other Study ID Numbers:	TC-09-06, TC-09-06
Study First Received:	January 21, 2010
Results First Received:	May 7, 2012
Last Updated:	May 7, 2012
Health Authority:	United States: Food and Drug Administration

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