Topical Compounded Pain Creams And Pain Perception (TOPCAPP)

NCT ID: NCT01862848

Last Updated: 2015-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

285 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-06-30

Brief Summary

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To evaluate the change in patient pain perception with the use of a topical compounded pain cream regimen.

Detailed Description

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This is a prospective,observational,single center, open label study of patients that receive a combination topical compounded analgesic medication with no comparator group.

Conditions

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Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Participants must be diagnosed with an ICD9 code indicative of chronic pain.
* Participants must be starting a new regimen of topical therapy with multiple compounded agents.
* Participants must be expecting to receive therapy for at least 12 weeks.
* Participants must be between 18 and 65 years of age.
* Participants must be able to provide sound written and verbal informed consent.

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 women.
* Participants must not have a diagnosis of cancer within the past 5 years.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medimix Specialty Pharmacy, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin J Epstein, PharmD

Role: STUDY_CHAIR

Medimix Specialty Pharmacy

Locations

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The Medimix Specialty Pharmacy, LLC

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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Gureje O, Von Korff M, Simon GE, Gater R. Persistent pain and well-being: a World Health Organization Study in Primary Care. JAMA. 1998 Jul 8;280(2):147-51. doi: 10.1001/jama.280.2.147.

Reference Type BACKGROUND
PMID: 9669787 (View on PubMed)

National Centers for Health Statistics, Chartbook on Trends in the Health Americans 2006, Special Feature: Pain. Available at: http://www.cdc.gov/nchs/data/hus/hus06.pdf. Accessed July 17,2012.

Reference Type BACKGROUND

Vorobeychik Y, Gordin V, Mao J, Chen L. Combination therapy for neuropathic pain: a review of current evidence. CNS Drugs. 2011 Dec 1;25(12):1023-34. doi: 10.2165/11596280-000000000-00000.

Reference Type BACKGROUND
PMID: 22133325 (View on PubMed)

Chaparro LE, Wiffen PJ, Moore RA, Gilron I. Combination pharmacotherapy for the treatment of neuropathic pain in adults. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD008943. doi: 10.1002/14651858.CD008943.pub2.

Reference Type BACKGROUND
PMID: 22786518 (View on PubMed)

American Pain Foundation. Breakthrough cancer pain: mending the break in the continuum of care. J Pain Palliat Care Pharmacother. 2011;25(3):252-64. doi: 10.3109/15360288.2011.599920.

Reference Type BACKGROUND
PMID: 21882979 (View on PubMed)

Flores MP, Castro AP, Nascimento Jdos S. Topical analgesics. Rev Bras Anestesiol. 2012 Mar-Apr;62(2):244-52. doi: 10.1016/S0034-7094(12)70122-8.

Reference Type BACKGROUND
PMID: 22440379 (View on PubMed)

Barkin RL. Topical Nonsteroidal Anti-Inflammatory Drugs: The Importance of Drug, Delivery, and Therapeutic Outcome. Am J Ther. 2015 Sep-Oct;22(5):388-407. doi: 10.1097/MJT.0b013e3182459abd.

Reference Type BACKGROUND
PMID: 22367354 (View on PubMed)

Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc., 2012. http://www.clinicalpharmacology.com

Reference Type BACKGROUND

Other Identifiers

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Medimix Pharm-01

Identifier Type: -

Identifier Source: org_study_id

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