Topical Compounded Pain Creams And Pain Perception (TOPCAPP)

Pain Clinical Trial

— TOPCAPP  

Official title:

Topical Compounded Pain Creams And Pain Perception (TOPCAPP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862848
• Other study ID #: Medimix Pharm-01
• Status: Completed
• Phase: N/A
• First received: May 22, 2013
• Last updated: June 12, 2015
• Start date: November 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: Medimix Specialty Pharmacy, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
United States	The Medimix Specialty Pharmacy, LLC	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Medimix Specialty Pharmacy, LLC

Country where clinical trial is conducted

United States, 

References & Publications (8)

American Pain Foundation. 2006 Report.

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. — View Citation

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;7:CD008943. doi: 10.1002/14651858.CD008943.pub2. Review. — View Citation

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

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. Review. — View Citation

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. Erratum in: JAMA 1998 Oct 7;280(13):1142. — View Citation

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.

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perceived pain changes	Minimal sample size of 60 persons(maximum n=150)with a diagnosis of chronic pain (n=30 neuropathic and n=30 nociceptive primary pain-type)to determine predictors of a 30% or greater reduction of pain scores evaluated by logistic regression analyses utilizing the Brief Pain Index scores.	12 Week Study [Baseline, 4,8, and 12 week evaluation]	No
Secondary	Quality of Life	To evaluate the change in quality of life using the EuroQol-5D-3L survey.	12 Weeks [Baseline,4,8, and 12 week evaluation]	No