Neurologic PainNCT02024802
Compounded Pain Creams and Patient Perception
An observational study of Neurologic Pain and Nociceptive Pain, run by Marwood LowCost Pharmacy at 1 site in United States.
Trial summary
There has been a significant increase in the number of prescriptions being filled for Custom Compounded Pain Creams. This study serves to evaluate the patient perception and satisfaction with this type of pain therapy allowing us to identify any statistically relevant relationships that may exist between this type of… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Neurologic Pain, Nociceptive Pain
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2015
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community sampling of patients with a diagnosis of neurologic or nociceptive pain whom will be beginning a new regimine of custom compounded pain cream as a pain management therapy.
Who may be able to join
- Participants must be in the range of 18 to 85 years of age as confirmed by state identification or passport presented upon completion of the informed consent.
- Participants must have a diagnosis indicative of either Neuropathic or Nociceptive Pain as confirmed with the prescribing medical provider.
- Participants must be starting a new regimen of transdermal (topic) pain therapy with multiple compounded reagents as indicated on prescription from medical provider
- Participants must be willing to participate in the study for a minimum of 12 weeks
- Participants must be able to provide written informed consent.
- Participants must be able to read and understand the english language
Who cannot join
- Participants must not have prior hypersensitivity or adverse events to any components of the customized prescription as indicated by their allergy history given upon registration at the pharmacy.
- Participants must not be pregnant or planning to become pregnant within the 12 week study period and must not be breastfeeding.
- Participants must not have a diagnosis for cancer in the last 5 years.
- Participants legally authorized representative (LAR) will not be a substitute for the participants' written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Marwood Low Cost Pharmacy
Indianapolis, Indiana, 46221
About this study
Official title: Clinical Trial: Transdermal Compounded Pain Creams and Patient Pain Perception
There has been a significant increase in the number of prescriptions being filled for Custom Compounded Pain Creams. This study serves to evaluate the patient perception and satisfaction with this type of pain therapy allowing us to identify any statistically relevant relationships that may exist between this type of therapy and patient pain perception. A secondary goal would be to identify any significantly relevant relationships that may exist between this change in pain perception (if any) and the patients overall sense of well-being. The investigators' null hypothesis is that greater that 85% of people will see an significant decrease in perceived pain levels and greater than 85% increase in patient overall sense of well being.
Read the detailed description
The purpose of this study is to evaluate the level of pain perceived by chronic neuropathic and/or inflammatory pain patients using a compounded transdermal pain cream as a pain management solution. Our goal is to identify statistically relevant relationships existing between this type of pain therapy and patients' perceived pain levels.
A secondary goal of this study is to identify any statistically relevant relationships between this change in pain perception (if any) and the patient's perception of overall well-being.
This will be an observational study with a cohort observational model study design. Patients whom have been prescribed a compounded pain cream regimen as a new pain therapy but have not yet begun the regimen will be recruited.
We will work with local prescribing neurologic, orthopedic and pain clinic physicians to identify patients who will be beginning this type of therapy in the near future. Prior to administering their first dose, the participants will need to complete the consenting process. Participants may opt to review and complete the informed consent form with their doctor or with a member of the pharmacy research team.
The custom survey entitled MLP-001-PC will be administered throughout the 12 week study at 4 week intervals (baseline, 4 weeks, 8 weeks, and 12 weeks).
Participants will not be required to come to the pharmacy to complete the subsequent surveys. They can be mailed or emailed at the participant's discretion. Any patient whom opts to receive their survey via mail or email will need to indicate so on their patient information form and provide a signature at that time stating that all surveys will be completed on one's own behalf (See Attachment 1).
If the participants opt to receive their surveys by mail, we will ask that they return their survey to the pharmacy either in person or in the stamped envelope that will be provided. Participants receiving their surveys by email, will need to return their completed surveys in person, by mail or by email.
We will follow up with the patients at 3 and 6 days after the distribution of the surveys to remind them to complete and return the surveys. Surveys which are not completed within one week of the respective follow-up date will be excluded from the study for that respective follow-up interval. These participants will still be encouraged to complete the next survey for the next follow-up date.
The study is projected to last one year from enrollment of the first subject to completion of the last subject's participation.
All results from the baseline and follow-up surveys will be scored and the data will be compiled on site. Statistical analysis (Multinomial Regressional Analysis) will be performed to identify all statistically relevant correlations. All data will be summarized and concluded.
A description of this clinical trial will be available on http://ClinicalTrials.gov, as required by U.S. Law.
- Conditions
- Neurologic Pain, Nociceptive Pain
- Keywords
- Pain, Pain Cream, Nociceptive pain, neurologic pain, transdermal, compounding, compound
- Medical subject headings
- Nociceptive Pain, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Pain Perception
Patients will complete surveys every 4 weeks throughout the 12 week evaluation to rate patient pain perception.
Measured: 12 weeks
Secondary outcomes (1)
Patient overall Sense of Well-Being
Patients will complete a survey every 4 weeks throughout the 12 week evaluation to rate their perception of overall well-being.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic PainStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marwood LowCost Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Akram Z Abu Mahfouz, MS, RPh, Principal investigator, Marwood Low Cost Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024802
- Sponsor's protocol ID
- MLP-001-PC
- Status last verified
- Jul 2014
- First submitted
- 28 Dec 2013
- Last updated
- 8 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial: Transdermal Compounded Pain Creams and Patient Pain Perception
- ClinicalTrials.gov ID
- NCT02024802
- Acronym / sponsor ID
- MLP-001-PC
- Conditions
- Neurologic Pain, Nociceptive Pain
- Keywords
- Pain, Pain Cream, Nociceptive pain, neurologic pain, transdermal, compounding, compound
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Marwood LowCost PharmacyUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 31 Dec 2013 (estimated)
- 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.
There has been a significant increase in the number of prescriptions being filled for Custom Compounded Pain Creams. This study serves to evaluate the patient perception and satisfaction with this type of pain therapy allowing us to identify any statistically relevant relationships that may exist between this type of therapy and patient pain perception. A secondary goal would be to identify any significantly relevant relationships that may exist between this change in pain perception (if any) and the patients overall sense of well-being. The investigators' null hypothesis is that greater that 85% of people will see an significant decrease in perceived pain levels and greater than 85% increase in patient overall sense of well being.
Detailed description
The purpose of this study is to evaluate the level of pain perceived by chronic neuropathic and/or inflammatory pain patients using a compounded transdermal pain cream as a pain management solution. Our goal is to identify statistically relevant relationships existing between this type of pain therapy and patients' perceived pain levels.
A secondary goal of this study is to identify any statistically relevant relationships between this change in pain perception (if any) and the patient's perception of overall well-being.
This will be an observational study with a cohort observational model study design. Patients whom have been prescribed a compounded pain cream regimen as a new pain therapy but have not yet begun the regimen will be recruited.
We will work with local prescribing neurologic, orthopedic and pain clinic physicians to identify patients who will be beginning this type of therapy in the near future. Prior to administering their first dose, the participants will need to complete the consenting process. Participants may opt to review and complete the informed consent form with their doctor or with a member of the pharmacy research team.
The custom survey entitled MLP-001-PC will be administered throughout the 12 week study at 4 week intervals (baseline, 4 weeks, 8 weeks, and 12 weeks).
Participants will not be required to come to the pharmacy to complete the subsequent surveys. They can be mailed or emailed at the participant's discretion. Any patient whom opts to receive their survey via mail or email will need to indicate so on their patient information form and provide a signature at that time stating that all surveys will be completed on one's own behalf (See Attachment 1).
If the participants opt to receive their surveys by mail, we will ask that they return their survey to the pharmacy either in person or in the stamped envelope that will be provided. Participants receiving their surveys by email, will need to return their completed surveys in person, by mail or by email.
We will follow up with the patients at 3 and 6 days after the distribution of the surveys to remind them to complete and return the surveys. Surveys which are not completed within one week of the respective follow-up date will be excluded from the study for that respective follow-up interval. These participants will still be encouraged to complete the next survey for the next follow-up date.
The study is projected to last one year from enrollment of the first subject to completion of the last subject's participation.
All results from the baseline and follow-up surveys will be scored and the data will be compiled on site. Statistical analysis (Multinomial Regressional Analysis) will be performed to identify all statistically relevant correlations. All data will be summarized and concluded.
A description of this clinical trial will be available on http://ClinicalTrials.gov, as required by U.S. Law.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sampling of patients with a diagnosis of neurologic or nociceptive pain whom will be beginning a new regimine of custom compounded pain cream as a pain management therapy.
Key inclusion criteria (6 listed)
- Participants must be in the range of 18 to 85 years of age as confirmed by state identification or passport presented upon completion of the informed consent.
- Participants must have a diagnosis indicative of either Neuropathic or Nociceptive Pain as confirmed with the prescribing medical provider.
- Participants must be starting a new regimen of transdermal (topic) pain therapy with multiple compounded reagents as indicated on prescription from medical provider
- Participants must be willing to participate in the study for a minimum of 12 weeks
- Participants must be able to provide written informed consent.
Key exclusion criteria (4 listed)
- Participants must not have prior hypersensitivity or adverse events to any components of the customized prescription as indicated by their allergy history given upon registration at the pharmacy.
- Participants must not be pregnant or planning to become pregnant within the 12 week study period and must not be breastfeeding.
- Participants must not have a diagnosis for cancer in the last 5 years.
- Participants legally authorized representative (LAR) will not be a substitute for the participants' written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Pain Perception
Time frame: 12 weeks
Patients will complete surveys every 4 weeks throughout the 12 week evaluation to rate patient pain perception.
1 secondary outcome
Patient overall Sense of Well-Being
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
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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.
Akram Z Abu Mahfouz, MS, RPh principal investigator
Marwood Low Cost Pharmacy
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 Neurologic Pain and Nociceptive Pain, run by Marwood LowCost Pharmacy 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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 8 Jul 2014. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Patient Pain Perception (time frame: 12 weeks). 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 8 Jul 2014.