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Completed

NCT Number: NCT01862848

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Medimix Specialty Pharmacy, LLC

Jacksonville, Florida, 32216, United States

About this study

This is a prospective,observational,single center, open label study of patients that receive a combination topical compounded analgesic medication with no comparator group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medimix Specialty Pharmacy, LLC

Industry

Registry information

Acronym: TOPCAPP

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 27, 2013
Registry last updated
Jun 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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