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

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ClinicalTrials.gov Identifier: NCT03768011
Recruitment Status : Enrolling by invitation
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Data Collection Analysis Business Management

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.

Condition or disease Intervention/treatment
Pain, Chronic Pain, Joint Pain Syndrome Combination Product: transdermal cream and or patch

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).

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : June 30, 2022

Intervention Details:
  • Combination Product: transdermal cream and or patch
    transdermal cream and/or transdermal patch(s) with or without oral medication


Primary Outcome Measures :
  1. 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. [ Time Frame: 36 months ]
    Collecting 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 Outcome Measures :
  1. Visual Analogue scales [ Time Frame: 36 months ]
    By utilizing the Visual analogue scale from the patients' perspective will generate real world data



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
a patient with joint pain, extremity pain, lumbar, thoracic and/or cervical pain, as part of the PI routine care or follows medical necessity and prescribes a combination topical cream and/or patch with or without non-narcotic oral medication independent of the study
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768011


Locations
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United States, Florida
DCABM
Land O' Lakes, Florida, United States, 33558
Sponsors and Collaborators
Data Collection Analysis Business Management

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Responsible Party: Data Collection Analysis Business Management
ClinicalTrials.gov Identifier: NCT03768011     History of Changes
Other Study ID Numbers: PAS1466
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Pain
Arthralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases