Subjective Observational Study of Patients Using Transdermal Cream Medication And/Or Transdermal Patches With Or Without Oral Non-Narcotic Medications

NCT ID: NCT03768011

Last Updated: 2018-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-01

Study Completion Date

2022-06-30

Brief Summary

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purpose of this study is to evaluate the level of pain perceived by patients using a transdermal cream and/or transdermal patch with or without an oral medication as a pain management solution.

Detailed Description

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The purpose of this minimal risk, observational study is to observe and document patients' perspective on how the combination of transdermal cream and/or transdermal patch(s) with or without oral medication can help reduce or eliminate the use of opiate(s).

Conditions

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Pain, Chronic Pain, Joint Pain Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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transdermal cream and or patch

transdermal cream and/or transdermal patch(s) with or without oral medication

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Participants must be diagnosed with an ICD10 code indicative of chronic pain
* Participants must be starting a new regimen of topical therapy with or without non-narcotic oral medication that has been deemed medically necessary and is independent of the study
* Participants must be expecting to receive therapy for at least 12 weeks
* Participants must be between 18 and 64 years of age
* Participants must be able to provide sound verbal informed consent

Exclusion Criteria

* Participants must not be a beneficiary of government funded healthcare program (i.e. Medicare, Medicaid, etc.)
* Participants must not have a diagnosis of cancer within the past 5 years
* Participants who have chronic pain conditions not expected to respond to topical pain medication such as deep abdominal pain, or from conditions such as cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Data Collection Analysis Business Management

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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DCABM

Land O' Lakes, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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PAS1466

Identifier Type: -

Identifier Source: org_study_id