Lexington Observational Study of Treatment With Compounded Pain Creams

NCT02195752 | Terminated

• 1 other identifier: LIS001
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 2

Brief Summary

A two-year + 3 Mo. observational study to track compliance and outcomes in adult patients prescribed compounded pharmaceutical creams for the treatment of pain. The project is designed to accumulate tracking information from both patients and physicians over the course of therapy as a supplement to the ordinary care that the patients will normally receive. We seek to discover aspects of successful and unsuccessful treatment using topical pain creams. This information will be analyzed and reports prepared of observations and emergent findings. These reports will be sent during the study every 1 or 2 months to patients, physicians and pharmacists who are participating in the Study. A final compilation of findings and observations will be circulated to participating patients, physicians and pharmacists.

Conditions

Chronic Pain; Acute Pain

Keywords

Compounded pain cream; Ordinary care; Compounding; Topical treatment; Analgesia

Outcome Measures

Primary Outcomes (1)

• Change in patient reported pain levels following treatment

  Across active subjects who have a Baseline pain level AND a followup pain level as of 1 year following first patient enrolled (FPI). Applies to the intended use of the pain cream as established by the diagnosis and area to be treated.

  One year following first patient enrolled

Secondary Outcomes (1)

• Patient global impression of benefit

  One year after first patient enrolled

Other Outcomes (1)

• Frequency that patients do NOT use the pain cream as instructed

  One year following first patient enrolled (FPI).

Study Arms (1)

Prescribed Compounded Pain Cream

The study is limited to patients who have been prescribed treatment with a topical compounded pain cream as a component of their ordinary care by a qualified physician.

Other: Compounded Pain Cream

Interventions

Compounded Pain Cream OTHER

All patients will have been prescribed a topical pain cream prepared by a qualified compounding pharmacy

Prescribed Compounded Pain Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Males and females at least 18 years of age residing in the United States

You may qualify if:

• be informed of the nature of the study and must give written informed consent
• be able to communicate effectively with study personnel
• be diagnosed with a condition for which the physician has prescribed a compounded pain cream.

You may not qualify if:

• History of allergy or adverse reaction to pain cream ingredients
• History of psychiatric disorders

Sponsors & Collaborators

• Lexington Independent Studies, LLC: lead
• Palm Beach CRO: collaborator

Study Sites (2)

Lido Chen

Laguna Hills, California, 92653, United States

Location

Adolphus Anekwe

Gary, Indiana, 46409, United States

Location

MeSH Terms

Conditions

Chronic Pain; Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Stephen A. Raymond, PhD

  Research and Marketing Consultants

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 21, 2014
• Study Start: November 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

US (2)