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NCT02205229 Clinical Trial

Compounded Pain Preparation Absorption Study

Pain Clinical Trial

— ComPASS  

Official title:
Compounded Pain Preparation Absorption Study (ComPPAS)

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT02205229
Other study ID # Medimix Pharm-03
Secondary ID
Status Suspended
Phase N/A
First received July 29, 2014
Last updated May 15, 2015
Start date August 2014
Est. completion date August 2015

Study information
Verified date May 2015
Source Medimix Specialty Pharmacy, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Suspended
Enrollment 40
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 65 Years
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Multi-ingredient, topical compounded medications

Locations
Country Name City State
United States Medimix Specialty Pharmacy Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Medimix Specialty Pharmacy, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum concentration of ingredients used in multi-ingredient, topical compounded medications 1 Month No
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