Compounded Pain Preparation Absorption Study | NCT02205229

Studies
Compounded Pain Preparation Absorption Study

NCT02205229

Sponsor

Medimix Specialty Pharmacy, LLC

Status

Suspended

Last Update Posted

May 18, 2015Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Pain

Interventions

Multi-ingredient, topical compounded medications

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Poor enrollment

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Aug 2015Estimated

Completion Date

Aug 2015Estimated

First Submitted Date

Jul 29, 2014

First Submission Date that Met QC Criteria

Jul 30, 2014

First Posted Date

Jul 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2015

Last Update Posted Date

May 18, 2015Estimated

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients receiving a topical compounded medication			Drug: Multi-ingredient, topical compounded medications

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multi-ingredient, topical compounded medications	Drug		Patients receiving a topical compounded medication

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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Medimix Specialty Pharmacy		Jacksonville	Florida	32216	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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