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

NCT03768011 | Unknown

• 1 other identifier: PAS1466
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Pain, Joint; Pain Syndrome

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (1)

• Visual Analogue scales

  36 months

Interventions

transdermal cream and or patch COMBINATION_PRODUCT

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Data Collection Analysis Business Management: lead

Study Sites (1)

DCABM

Land O' Lakes, Florida, 33558, United States

Location

MeSH Terms

Conditions

Chronic Pain; Arthralgia; Somatoform Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Joint Diseases; Musculoskeletal Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2018
• First Posted: December 7, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: June 30, 2022
• Last Updated: December 7, 2018

Record last verified: 2018-12

Locations

US (1)