Topical Compounded Pain Creams And Pain Perception (TOPCAPP)
Overview[ - collapse ][ - ]
| Purpose | To evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen. |
|---|---|
| Condition | Pain |
| Intervention | Not Provided |
| Phase | N/A |
| Sponsor | Medimix Specialty Pharmacy, LLC |
| Responsible Party | Medimix Specialty Pharmacy, LLC |
| ClinicalTrials.gov Identifier | NCT01862848 |
| First Received | May 22, 2013 |
| Last Updated | May 28, 2013 |
| Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 22, 2013 |
|---|---|
| Last Updated Date | May 28, 2013 |
| Start Date | November 2012 |
| Estimated Primary Completion Date | May 2014 |
| Current Primary Outcome Measures | Perceived pain changes [Time Frame: 12 Week Study [Baseline, 4,8, and 12 week evaluation]] [Designated as safety issue: No]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. |
| Current Secondary Outcome Measures | Quality of Life [Time Frame: 12 Weeks [Baseline,4,8, and 12 week evaluation]] [Designated as safety issue: No]To evaluate the change in quality of life using the EuroQol-5D-3L survey. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Topical Compounded Pain Creams And Pain Perception (TOPCAPP) |
|---|---|
| Official Title | Topical Compounded Pain Creams And Pain Perception (TOPCAPP) |
| Brief Summary | 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 Type | Observational [Patient Registry] |
| Study Phase | N/A |
| Study Design | Observational Model: Cohort, Time Perspective: Prospective |
| Condition | Pain |
| Intervention | Not Provided |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Enrolling by invitation |
|---|---|
| Estimated Enrollment | 150 |
| Estimated Completion Date | May 2014 |
| Estimated Primary Completion Date | May 2014 |
| Eligibility Criteria | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01862848 |
|---|---|
| Other Study ID Numbers | Medimix Pharm-01 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Medimix Specialty Pharmacy, LLC |
| Study Sponsor | Medimix Specialty Pharmacy, LLC |
| Collaborators | Not Provided |
| Investigators | Study Chair: Benjamin J Epstein, PharmD Medimix Specialty Pharmacy |
| Verification Date | May 2013 |
Locations[ + expand ][ + ]
| The Medimix Specialty Pharmacy, LLC | Jacksonville, Florida, United States, 32216 |
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