Pain, ChronicNCT03768011
Subjective Observational Study of Patients Using Transdermal Cream Medication And/Or Transdermal Patches With Or Without Oral Non-Narcotic Medications
An observational study of Pain, Chronic and Pain, Joint, run by Data Collection Analysis Business Management at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Chronic, Pain, Joint, Pain Syndrome
- What is being tested?
- transdermal cream and or patch
- Type of treatment
- Pill or oral medicine
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Pain, Chronic, Pain, Joint, Pain Syndrome
- Being tested
- transdermal cream and or patch
- Medical subject headings
- Chronic Pain, Arthralgia, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transdermal cream and or patchCombination product
transdermal cream and/or transdermal patch(s) with or without oral medication
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 36 months
Secondary outcomes (1)
Visual Analogue scales
By utilizing the Visual analogue scale from the patients' perspective will generate real world data
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Dec 2018
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Data Collection Analysis Business Management
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768011
- Sponsor's protocol ID
- PAS1466
- Status last verified
- Dec 2018
- First submitted
- 1 Dec 2018
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03768011
- Acronym / sponsor ID
- PAS1466
- Conditions
- Pain, Chronic, Pain, Joint, Pain Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Data Collection Analysis Business ManagementUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transdermal cream and or patchtransdermal cream and/or transdermal patch(s) with or without oral medication | Combination product | – |
Primary outcome
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).
1 secondary outcome
Visual Analogue scales
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Chronic and Pain, Joint, run by Data Collection Analysis Business Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.