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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Description Of Data Relevant to Objectives:

The primary objective of this study is to document clinical experience. Specifically, the study will collect:

  1. The expectations from both patient and physician. These underlie patient willingness to use a topical therapy, and the physician's motivation in prescribing.
  2. 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?
  3. Patterns of use of the creams. Do patients follow the prescription; do they adapt frequency and location of application? Why?
  4. 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?
  5. 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.
  6. 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?
  7. 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.
  8. 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:

  1. Data capture is done at visits using structured forms developed in consultation with treating physicians.
  2. 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.
  3. 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.
  4. Checklists for each visit are completed as part of the trial record to ensure standard processes are followed by treating physicians.
  5. 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.
  6. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United States
    • California
      • Laguna Hills, California, United States, 92653
        • Lido Chen
    • Indiana
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
All patients will have been prescribed a topical pain cream prepared by a qualified compounding pharmacy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lexington Independent Studies, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Palm Beach CRO

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Chronic Pain

Clinical Trials on Compounded Pain Cream

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings