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Compounded Pain Preparation Absorption Study

Compounded Pain Preparation Absorption Study (ComPPAS)

Status
Suspended
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02205229
Acronym
ComPASS
Enrollment
40
Registered
2014-07-31
Start date
2014-08-31
Completion date
2015-08-31
Last updated
2015-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

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.

Interventions

DRUGMulti-ingredient, topical compounded medications

Sponsors

Medimix Specialty Pharmacy, LLC
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Serum concentration of ingredients used in multi-ingredient, topical compounded medications1 Month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026