Compounded Pain Preparation Absorption Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-08-31

Brief Summary

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

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Detailed Description

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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 to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications.

Conditions

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving a topical compounded medication

Multi-ingredient, topical compounded medications

Intervention Type DRUG

Interventions

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Multi-ingredient, topical compounded medications

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 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
* 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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No