Status:
SUSPENDED
Compounded Pain Preparation Absorption Study
Lead Sponsor:
Medimix Specialty Pharmacy, LLC
Conditions:
Pain
Eligibility:
All Genders
30-65 years
Brief Summary
Single center, prospective, observational study to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy.
Detailed Description
Single center, prospective, observational, open-label, cohort study of participants that receive a combination topical pain medication from Medimix Specialty Pharmacy with no comparator group designed...
Eligibility Criteria
Inclusion
- Participants must apply and consistently use the supplied cream for 1 month at a prescribed
- Participants must be ≥ 30 and \<65 years of age
- Participants must be able to provide sound written and verbal informed consent
- Participants must be diagnosed with an ICD9 code indicative of chronic pain
Exclusion
- 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
- Participants must not have used any study drug greater than 180 days from the day of Screening
- Participants must not be utilizing medications that may interact with those being used in the topical formulation as determined by the PI
- Participants must not be using any systemic medications that may influence drug serum concentrations of ingredients being used in the topical compound. These include medications from the same class of studied drugs or drugs that may falsely increase or decrease serum levels of the study drugs
Key Trial Info
Start Date :
August 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02205229
Start Date
August 1 2014
End Date
August 1 2015
Last Update
May 18 2015
Active Locations (1)
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1
Medimix Specialty Pharmacy
Jacksonville, Florida, United States, 32216