NCT01862848

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
285

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

2.6 years

First QC Date

May 22, 2013

Last Update Submit

June 12, 2015

Conditions

Pain

Keywords

Topical Compounded Pain Creams and Pain Perception

Outcome Measures

Primary Outcomes (1)

  • 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]

Secondary Outcomes (1)

  • Quality of Life

    12 Weeks [Baseline,4,8, and 12 week evaluation]

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with neuropathic or nociceptive chronic pain who are between 18 and 65 years of age prescribed a combination compounded topical analgesic.

You may qualify if:

  • 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.

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 women.
  • Participants must not have a diagnosis of cancer within the past 5 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Medimix Specialty Pharmacy, LLC

Jacksonville, Florida, 32216, United States

Location

Related Publications (8)

  • 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.

    PMID: 9669787BACKGROUND

  • 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.

    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.

    PMID: 22133325BACKGROUND

  • 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.

    PMID: 22786518BACKGROUND

  • 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.

    PMID: 21882979BACKGROUND

  • 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.

    PMID: 22440379BACKGROUND

  • 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.

    PMID: 22367354BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benjamin J Epstein, PharmD

    Medimix Specialty Pharmacy

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

May 22, 2013

First Posted

May 27, 2013

Study Start

November 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations

US(1)