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

December 5, 2018 updated by: Data Collection Analysis Business Management

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Land O' Lakes, Florida, United States, 33558
        • DCABM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue scales
Time Frame: 36 months
By utilizing the Visual analogue scale from the patients' perspective will generate real world data
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Data Collection Analysis Business Management

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

December 1, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

December 7, 2018

Last Update Submitted That Met QC Criteria

December 5, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAS1466

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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