Topical Compounded Pain Creams And Pain Perception (TOPCAPP)

Overview

To evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2015

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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Quality of Life
    • Time Frame: 12 Weeks [Baseline,4,8, and 12 week evaluation]
    • To evaluate the change in quality of life using the EuroQol-5D-3L survey.

Participating in This Clinical Trial

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 Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Medimix Specialty Pharmacy, LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Benjamin J Epstein, PharmD, Study Chair, Medimix Specialty Pharmacy

References

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. Erratum in: JAMA 1998 Oct 7;280(13):1142.

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.

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. Review.

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;(7):CD008943. doi: 10.1002/14651858.CD008943.pub2. Review.

American Pain Foundation. 2006 Report.

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. Review.

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.

Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc., 2012. http://www.clinicalpharmacology.com

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