Compounded Pain Preparation Absorption Study (ComPASS)

Medimix Specialty Pharmacy, LLC

Status: Suspended

Conditions: Pain

Treatments: Drug: Multi-ingredient, topical compounded medications

Study type: Observational

Funder types: Industry

Identifiers

NCT02205229

Medimix Pharm-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Patients receiving a topical compounded medication

Treatment:

Drug: Multi-ingredient, topical compounded medications