Compounded Pain Preparation Absorption Study (ComPASS)

May 15, 2015 updated by: Medimix Specialty Pharmacy, LLC

Compounded Pain Preparation Absorption Study (ComPPAS)

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

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32216
        • Medimix Specialty Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient between the ages of 30 and <65 years old not taking concomitant medications that may interact with study ingredients.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients receiving a topical compounded medication
Drug: Multi-ingredient, topical compounded medications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum concentration of ingredients used in multi-ingredient, topical compounded medications
Time Frame: 1 Month
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medimix Specialty Pharmacy, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

August 1, 2015

Study Registration Dates

First Submitted

July 29, 2014

First Submitted That Met QC Criteria

July 30, 2014

First Posted (Estimate)

July 31, 2014

Study Record Updates

Last Update Posted (Estimate)

May 18, 2015

Last Update Submitted That Met QC Criteria

May 15, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • Medimix Pharm-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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