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

A Subjective Observational Study of Patients Using Transdermal Cream Medication And/Or Transdermal Patches With Or Without Oral Non-Narcotic Medications to Help Reduce or Eliminate Use of Opiates

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03768011
Enrollment
5000
Registered
2018-12-07
Start date
2018-12-01
Completion date
2022-06-30
Last updated
2018-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Chronic, Pain, Joint, Pain Syndrome

Brief summary

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

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).

Interventions

COMBINATION_PRODUCTtransdermal cream and or patch

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

Sponsors

Data Collection Analysis Business Management
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Patients' perspective through a patient led Survey of Health and quality of life via patient reported outcome measures using Visual analogue scale given at Baseline and follow up. Measuring pain from 0 no pain to 10 highest pain level.36 monthsCollecting and analyzing quantitative and qualitative data to draw generalized outcome measures, on real world data.Data from the subject surveys will analyze and measure the effectiveness through a subjective observation via patients' perspective survey on transdermal cream and/or transdermal patches with or without oral non-narcotic medication and if it helped with the reduction or elimination of opiate(s).

Secondary

MeasureTime frameDescription
Visual Analogue scales36 monthsBy utilizing the Visual analogue scale from the patients' perspective will generate real world data

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026