Compounded Pain Preparation Absorption Study

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Conditions studied: Pain

In brief

Single center, prospective, observational study to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy.

Key facts

Study ID

NCT02205229

Run by

Medimix Specialty Pharmacy, LLC

People needed

40

Starts

2014-08-01

Expected to finish

2015-08-01

Last updated by the study team

2015-05-18

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Medimix Specialty Pharmacy — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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