Osteoarthritis in Older Adults: Recovery of Mobility and... | NCT01565070

Studies
Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

NCT01565070

Sponsor

University of Chile

Status

Withdrawn

Last Update Posted

Jul 10, 2014Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Knee Osteoarthritis

Interventions

Biofreeze
Placebo

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HYGIENIC CORPORATION	Other Grant/Funding Number	HYGIENIC CORPORATION

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The local authorities did not authorize the use of biofreeze in Chile.

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Oct 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Mar 26, 2012

First Submission Date that Met QC Criteria

Mar 27, 2012

First Posted Date

Mar 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2014

Last Update Posted Date

Jul 10, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biofreeze	Active Comparator		Drug: Biofreeze
Placebo	Placebo Comparator	Use of placebo ointment	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biofreeze	Drug	Use of Biofreeze ointment	Biofreeze
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
WOMAC score	WOMAC score corresponds to Western Ontario and McMaster Universities Index of Osteoarthritis	60 days

Secondary Outcomes

Measure	Description	Time Frame
Quality of life measured using SF 36	SF 36 correponds to a health related quality of life score	60 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate osteoarthritis of the knee
Age 60 to 80 years
Ambulatory

Exclusion Criteria:

Other conditions that affect mobility
Severe chronic diseases such as cardiac or renal failure
Cancer
Presence of gout
Cognitive impairment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Bunout, MD	INTA University of Chile	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Nutrition and Food Technology		Santiago	Met	7830489	Chile

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19674721	Background	Zhang J, Enix D, Snyder B, Giggey K, Tepe R. Effects of Biofreeze and chiropractic adjustments on acute low back pain: a pilot study. J Chiropr Med. 2008 Jun;7(2):59-65. doi: 10.1016/j.jcme.2008.02.004.

ID	Term
D020370	Osteoarthritis, Knee
D010003	Osteoarthritis
D010146	Pain

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases