- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02195752
Lexington Observational Study of Treatment With Compounded Pain Creams (TrackingCPC)
May 7, 2015 updated by: Lexington Independent Studies, LLC
Observational Study of Patient and Physician Experiences During Treatment of Pain With Compounded Pharmaceuticals
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Description Of Data Relevant to Objectives:
The primary objective of this study is to document clinical experience. Specifically, the study will collect:
- The expectations from both patient and physician. These underlie patient willingness to use a topical therapy, and the physician's motivation in prescribing.
- What is prescribed and used. The composition of compounded creams vary. Is there an association between the agents / concentrations and the effects on different types of pain?
- Patterns of use of the creams. Do patients follow the prescription; do they adapt frequency and location of application? Why?
- What happens with use? Do pain scores change? How quickly, and in what ways do pain scores change with different diagnoses? What is the impact on patient lives? Are expectations typically fulfilled and/or are there surprises and emergent findings?
- Observations and structured assessments to tabulate the aspects of successful and unsuccessful treatment using topical pain creams of various compositions and for diverse underlying complaints.
- The level of satisfaction and perceived benefit. If treatment is discontinued, is it because the problem has been resolved? Or is there burden, cost or lack of benefit?
- Separate confidential information from patients and physicians so that the study team can learn how closely the patients' observations match those of the physicians. The level and nature of the correspondence between patient observations and clinician observations (or lack of it) will be shared in reports sent to study participants. Such reports will not disclose the identities of either physicians or patients.
- Comments on reports. An area of interest for the study is to investigate the interest in physicians and patients in the reports to be generated concerning the observations from other patients and other physicians. Will patients be interested in their trajectory of treatment? Will sharing the information impact the perceived value of treatment?
Registry Procedures:
- Data capture is done at visits using structured forms developed in consultation with treating physicians.
- Patient data: Patients enter ratings and information using encoded paper forms that are then sent by mail directly to the Lexington data entry service, or online using a secure login to send forms to the study database. Such direct from patient transfer is intended to reduce bias that would otherwise influence self assessments of treatment benefit because of the desire of the patient to please the treating physician.
- Diagnostic standards: International Statistical Classification of Diseases and Related Health Problems, Ninth Revision (ICD9) or International Statistical Classification of Diseases and Related Health Problems, Tenth Revision ( ICD10) codes for diagnosis of pain conditions to be treated are required.
- Checklists for each visit are completed as part of the trial record to ensure standard processes are followed by treating physicians.
- If missing or illegible data are not resolvable, then there will be NO imputation. Reports and analysis will be based only on entries where source values were clear. Data entry forms include range and completeness checks, prevention of illogical entry. Free text fields are important for capturing unexpected events and observations. These will be recorded verbatim into the database.
- There is no primary hypothesis under test. Observations reported will include counts for instances and trends. Assessments and ratings will be reported as averages and distributions.
Study Type
Observational
Enrollment (Actual)
26
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Laguna Hills, California, United States, 92653
- Lido Chen
-
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Indiana
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Gary, Indiana, United States, 46409
- Adolphus Anekwe
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Males and females at least 18 years of age residing in the United States
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- History of allergy or adverse reaction to pain cream ingredients
- History of psychiatric disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
All patients will have been prescribed a topical pain cream prepared by a qualified compounding pharmacy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient reported pain levels following treatment
Time Frame: One year following first patient enrolled
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient global impression of benefit
Time Frame: One year after first patient enrolled
|
Assessed by a structured VAS for completion at followup and final visits.
Will be assessed for all patients who have reported on the first followup visit.
Mean and distribution will be reported.
|
One year after first patient enrolled
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency that patients do NOT use the pain cream as instructed
Time Frame: One year following first patient enrolled (FPI).
|
Both incidence (a count and percentage) and 5 most common reasons given by patients for not following the prescription will be reported.
The information is proactively captured at followup visits.
Baseline establishes prescribed use.
Followup items probe for uses inconsistent with prescription.
The population will include all subjects as of 1 year following FPI who have reported a followup visit.
|
One year following first patient enrolled (FPI).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Stephen A. Raymond, PhD, Research and Marketing Consultants
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
July 15, 2014
First Submitted That Met QC Criteria
July 16, 2014
First Posted (Estimate)
July 21, 2014
Study Record Updates
Last Update Posted (Estimate)
May 12, 2015
Last Update Submitted That Met QC Criteria
May 7, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIS001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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