Clinical trial NCT01862848: Topical Compounded Pain Creams And Pain Perception (TOPCAPP)
Official title: Topical Compounded Pain Creams And Pain Perception (TOPCAPP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Topical Compounded Pain Creams and Pain Perception
Lead sponsor: Medimix Specialty Pharmacy, LLC
Sponsor class: INDUSTRY
First posted: 2013-05-27
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with neuropathic or nociceptive chronic pain who are between 18 and 65 years of age prescribed a combination compounded topical analgesic.

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.

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.

Primary outcomes:
measure: Perceived pain changes
timeFrame: 12 Week Study [Baseline, 4,8, and 12 week evaluation]
Secondary outcomes:
measure: Quality of Life
timeFrame: 12 Weeks [Baseline,4,8, and 12 week evaluation]
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: The Medimix Specialty Pharmacy, LLC
state: Florida
Study officials:
affiliation: Medimix Specialty Pharmacy
name: Benjamin J Epstein, PharmD
role: STUDY_CHAIR
References:
citation: 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.
citation: National 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.
citation: 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.
citation: Chaparro 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.
citation: American 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.
citation: Flores 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.
citation: Barkin 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.
citation: Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc., 2012. http://www.clinicalpharmacology.com