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Topical Compounded Pain Creams And Pain Perception (TOPCAPP) (TOPCAPP)

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ClinicalTrials.gov Identifier: NCT01862848
Recruitment Status : Completed
First Posted : May 27, 2013
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
Medimix Specialty Pharmacy, LLC

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

Condition or disease
Pain

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]
Actual Enrollment : 285 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Weeks
Official Title: Topical Compounded Pain Creams And Pain Perception (TOPCAPP)
Study Start Date : November 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862848


Locations
United States, Florida
The Medimix Specialty Pharmacy, LLC
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
Medimix Specialty Pharmacy, LLC
Investigators
Study Chair: Benjamin J Epstein, PharmD Medimix Specialty Pharmacy

Publications:
Responsible Party: Medimix Specialty Pharmacy, LLC
ClinicalTrials.gov Identifier: NCT01862848     History of Changes
Other Study ID Numbers: Medimix Pharm-01
First Posted: May 27, 2013    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015

Keywords provided by Medimix Specialty Pharmacy, LLC:
Topical Compounded Pain Creams and Pain Perception