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

Pain, Chronic Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03768011
• Other study ID #: PAS1466
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Arthralgia
• Chronic Pain
• Pain Syndrome
• Pain, Chronic
• Pain, Joint

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