PainComPASSNCT02205229
Compounded Pain Preparation Absorption Study
An observational study of Pain, run by Medimix Specialty Pharmacy, LLC at 1 site in United States.
Trial summary
Single center, prospective, observational study to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Multi-ingredient, topical compounded medications
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Aug 2015
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient between the ages of 30 and <65 years old not taking concomitant medications that may interact with study ingredients.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medimix Specialty Pharmacy
Jacksonville, Florida, 32216
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- Multi-ingredient, topical compounded medications
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-ingredient, topical compounded medicationsDrug
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving a topical compounded medication | Not described Receives: Drug: Multi-ingredient, topical compounded medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of ingredients used in multi-ingredient, topical compounded medications
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Medimix Specialty Pharmacy, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205229
- Sponsor's protocol ID
- Medimix Pharm-03
- Acronym
- ComPASS
- Status last verified
- May 2015
- First submitted
- 29 Jul 2014
- Last updated
- 18 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compounded Pain Preparation Absorption Study (ComPPAS)
- ClinicalTrials.gov ID
- NCT02205229
- Acronym / sponsor ID
- ComPASS / Medimix Pharm-03
- Conditions
- Pain
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Poor enrollment
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medimix Specialty Pharmacy, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving a topical compounded medication | – | Drug: Multi-ingredient, topical compounded medications |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient between the ages of 30 and <65 years old not taking concomitant medications that may interact with study ingredients.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-ingredient, topical compounded medications | Drug | Patients receiving a topical compounded medication |
Primary outcome
Serum concentration of ingredients used in multi-ingredient, topical compounded medications
Time frame: 1 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Medimix Specialty Pharmacy, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of ingredients used in multi-ingredient, topical compounded medications (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.