Topical Compounded Pain Creams And Pain Perception (TOPCAPP)

Brief Summary

Official Title: “Topical Compounded Pain Creams And Pain Perception (TOPCAPP)”

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

  • Study Type: Observational [Patient Registry]
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: May 2015

Detailed Clinical Trial 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Perceived pain changes
    • Time Frame: 12 Week Study [Baseline, 4,8, and 12 week evaluation]
      Safety Issue?: No

Secondary Measures

  • Quality of Life
    • Time Frame: 12 Weeks [Baseline,4,8, and 12 week evaluation]
      Safety Issue?: No

Criteria for Participation 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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • 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.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01862848