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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03768011
Other study ID # PAS1466
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 1, 2018
Est. completion date June 30, 2022

Study information

Verified date December 2018
Source Data Collection Analysis Business Management
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 5000
Est. completion date June 30, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States DCABM Land O' Lakes Florida

Sponsors (1)

Lead Sponsor Collaborator
Data Collection Analysis Business Management

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 Visual Analogue scales By utilizing the Visual analogue scale from the patients' perspective will generate real world data 36 months
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