NCT02205229

Brief Summary

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

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 18, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

July 29, 2014

Last Update Submit

May 15, 2015

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Serum concentration of ingredients used in multi-ingredient, topical compounded medications

    1 Month

Study Arms (1)

Patients receiving a topical compounded medication

Drug: Multi-ingredient, topical compounded medications

Interventions

Multi-ingredient, topical compounded medicationsDRUG
Patients receiving a topical compounded medication

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medimix Specialty Pharmacy

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2014

First Posted

July 31, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 18, 2015

Record last verified: 2015-05

Locations

US(1)