Compounded Pain Preparation Absorption Study

Suspended

• Conditions: Pain
• Interventions: Drug: Multi-ingredient, topical compounded medications

• Registration Number: NCT02205229
• Lead Sponsor: Medimix Specialty Pharmacy, LLC

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

Study Timeline

• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Study Start: 2014-08
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-15
• Last Update Posted: 2015-05-18
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving a topical compounded medication	Multi-ingredient, topical compounded medications	-

Primary Outcome Measures

Name	Time	Method
Serum concentration of ingredients used in multi-ingredient, topical compounded medications	1 Month

Trial Locations

Locations (1)

Medimix Specialty Pharmacy; 🇺🇸 Jacksonville, Florida, United States