PainTOPCAPPNCT01862848
Topical Compounded Pain Creams And Pain Perception (TOPCAPP)
An observational study of Pain, run by Medimix Specialty Pharmacy, LLC at 1 site in United States.
Trial summary
To evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- How many people
- 285 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2015
- How long will I take part?
- 12 Weeks
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with neuropathic or nociceptive chronic pain who are between 18 and 65 years of age prescribed a combination compounded topical analgesic.
Who may be able to join
- Participants must be diagnosed with an ICD9 code indicative of chronic pain.
- Participants must be starting a new regimen of topical therapy with multiple compounded agents.
- Participants must be expecting to receive therapy for at least 12 weeks.
- Participants must be between 18 and 65 years of age.
- Participants must be able to provide sound written and verbal informed consent.
Who cannot join
- Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.
- Participants must not be pregnant or breastfeeding women.
- Participants must not have a diagnosis of cancer within the past 5 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medimix Specialty Pharmacy, LLC
Jacksonville, Florida, 32216
About this study
To evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen.
Read the detailed description
This is a prospective,observational,single center, open label study of patients that receive a combination topical compounded analgesic medication with no comparator group.
- Conditions
- Pain
- Keywords
- Topical Compounded Pain Creams and Pain Perception
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived pain changes
Minimal sample size of 60 persons(maximum n=150)with a diagnosis of chronic pain (n=30 neuropathic and n=30 nociceptive primary pain-type)to determine predictors of a 30% or greater reduction of pain scores evaluated by logistic regression analyses utilizing the Brief Pain Index scores.
Measured: 12 Week Study [Baseline, 4,8, and 12 week evaluation]
Secondary outcomes (1)
Quality of Life
To evaluate the change in quality of life using the EuroQol-5D-3L survey.
Measured: 12 Weeks [Baseline,4,8, and 12 week evaluation]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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
- 285 participants (actual)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Medimix Specialty Pharmacy, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin J Epstein, PharmD, Study chair, Medimix Specialty Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862848
- Sponsor's protocol ID
- Medimix Pharm-01
- Acronym
- TOPCAPP
- Status last verified
- Jun 2015
- First submitted
- 22 May 2013
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gureje O, Von Korff M, Simon GE, Gater R. Persistent pain and well-being: a World Health Organization Study in Primary Care. JAMA. 1998 Jul 8;280(2):147-51. doi: 10.1001/jama.280.2.147.
PubMed 9669787National Centers for Health Statistics, Chartbook on Trends in the Health Americans 2006, Special Feature: Pain. Available at: http://www.cdc.gov/nchs/data/hus/hus06.pdf. Accessed July 17,2012.
Vorobeychik Y, Gordin V, Mao J, Chen L. Combination therapy for neuropathic pain: a review of current evidence. CNS Drugs. 2011 Dec 1;25(12):1023-34. doi: 10.2165/11596280-000000000-00000.
PubMed 22133325Chaparro LE, Wiffen PJ, Moore RA, Gilron I. Combination pharmacotherapy for the treatment of neuropathic pain in adults. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD008943. doi: 10.1002/14651858.CD008943.pub2.
PubMed 22786518American Pain Foundation. Breakthrough cancer pain: mending the break in the continuum of care. J Pain Palliat Care Pharmacother. 2011;25(3):252-64. doi: 10.3109/15360288.2011.599920.
PubMed 21882979Flores MP, Castro AP, Nascimento Jdos S. Topical analgesics. Rev Bras Anestesiol. 2012 Mar-Apr;62(2):244-52. doi: 10.1016/S0034-7094(12)70122-8.
PubMed 22440379Barkin RL. Topical Nonsteroidal Anti-Inflammatory Drugs: The Importance of Drug, Delivery, and Therapeutic Outcome. Am J Ther. 2015 Sep-Oct;22(5):388-407. doi: 10.1097/MJT.0b013e3182459abd.
PubMed 22367354Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc., 2012. http://www.clinicalpharmacology.com
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Compounded Pain Creams And Pain Perception (TOPCAPP)
- ClinicalTrials.gov ID
- NCT01862848
- Acronym / sponsor ID
- TOPCAPP / Medimix Pharm-01
- Conditions
- Pain
- Keywords
- Topical Compounded Pain Creams and Pain Perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Medimix Specialty Pharmacy, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 May 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.
To evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen.
Detailed description
This is a prospective,observational,single center, open label study of patients that receive a combination topical compounded analgesic medication with no comparator group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with neuropathic or nociceptive chronic pain who are between 18 and 65 years of age prescribed a combination compounded topical analgesic.
Key inclusion criteria (5 listed)
- Participants must be diagnosed with an ICD9 code indicative of chronic pain.
- Participants must be starting a new regimen of topical therapy with multiple compounded agents.
- Participants must be expecting to receive therapy for at least 12 weeks.
- Participants must be between 18 and 65 years of age.
- Participants must be able to provide sound written and verbal informed consent.
Key exclusion criteria (3 listed)
- Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription.
- Participants must not be pregnant or breastfeeding women.
- Participants must not have a diagnosis of cancer within the past 5 years.
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
Perceived pain changes
Time frame: 12 Week Study [Baseline, 4,8, and 12 week evaluation]
Minimal sample size of 60 persons(maximum n=150)with a diagnosis of chronic pain (n=30 neuropathic and n=30 nociceptive primary pain-type)to determine predictors of a 30% or greater reduction of pain scores evaluated by logistic regression analyses utilizing the Brief Pain Index scores.
1 secondary outcome
Quality of Life
Time frame: 12 Weeks [Baseline,4,8, and 12 week evaluation]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Background: PubMed 9669787Gureje O, Von Korff M, Simon GE, Gater R. Persistent pain and well-being: a World Health Organization Study in Primary Care. JAMA. 1998 Jul 8;280(2):147-51. doi: 10.1001/jama.280.2.147.
- BackgroundNational Centers for Health Statistics, Chartbook on Trends in the Health Americans 2006, Special Feature: Pain. Available at: http://www.cdc.gov/nchs/data/hus/hus06.pdf. Accessed July 17,2012.
- Background: PubMed 22133325Vorobeychik Y, Gordin V, Mao J, Chen L. Combination therapy for neuropathic pain: a review of current evidence. CNS Drugs. 2011 Dec 1;25(12):1023-34. doi: 10.2165/11596280-000000000-00000.
- Background: PubMed 22786518Chaparro LE, Wiffen PJ, Moore RA, Gilron I. Combination pharmacotherapy for the treatment of neuropathic pain in adults. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD008943. doi: 10.1002/14651858.CD008943.pub2.
- Background: PubMed 21882979American Pain Foundation. Breakthrough cancer pain: mending the break in the continuum of care. J Pain Palliat Care Pharmacother. 2011;25(3):252-64. doi: 10.3109/15360288.2011.599920.
- Background: PubMed 22440379Flores MP, Castro AP, Nascimento Jdos S. Topical analgesics. Rev Bras Anestesiol. 2012 Mar-Apr;62(2):244-52. doi: 10.1016/S0034-7094(12)70122-8.
- Background: PubMed 22367354Barkin RL. Topical Nonsteroidal Anti-Inflammatory Drugs: The Importance of Drug, Delivery, and Therapeutic Outcome. Am J Ther. 2015 Sep-Oct;22(5):388-407. doi: 10.1097/MJT.0b013e3182459abd.
- BackgroundClinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc., 2012. http://www.clinicalpharmacology.com
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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.
Benjamin J Epstein, PharmD study chair
Medimix Specialty 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 Pain, run by Medimix Specialty Pharmacy, LLC 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: finished, as of the sponsor's last update on 15 Jun 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived pain changes (time frame: 12 Week Study [Baseline, 4,8, and 12 week evaluation]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01862848, which also lists 8 linked publications.
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 15 Jun 2015.