Trial record 3 of 16760 for:    DOLORES

Treat and Track Observational Study of Patients Prescribed Topical Pain Creams (T&T-Pain)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Research & Marketing Consultants, Inc.
Sponsor:
Information provided by (Responsible Party):
Research & Marketing Consultants, Inc.
ClinicalTrials.gov Identifier:
NCT02195752
First received: July 15, 2014
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Chronic Pain
Acute Pain
Other: Compounded Pain Cream

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Treat and Track: Tracking Patient and Physician Experiences During Treatment of Pain With Compounded Pharmaceuticals

Resource links provided by NLM:


Further study details as provided by Research & Marketing Consultants, Inc.:

Primary Outcome Measures:
  • Change in patient reported pain levels following treatment [ Time Frame: One year following first patient enrolled ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient global impression of benefit [ Time Frame: One year after first patient enrolled ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Frequency that patients do NOT use the pain cream as instructed [ Time Frame: One year following first patient enrolled (FPI). ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1000
Study Start Date: August 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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 is captured to encoded forms sent by mail directly to the T&T data entry service 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02195752

Contacts
Contact: Stephen A. Raymond, PhD 617 549 1229 sraymond@rm-consultants.com

Locations
United States, California
Epic Aesthetic Medical Inst. Not yet recruiting
Encino, California, United States, 91346
Contact: Jasmin Javaherian, MD    818-501-3366      
Principal Investigator: Jasmin Javaherian, DO         
Albeer Ibrahim, MD Recruiting
Encino, California, United States, 91436
Contact: Albeer Ibrahim, MD    818-789-7937    ablbeeribrahim@gmail.com   
Contact: Yensy Calero    818 789 7937      
Principal Investigator: Albeer Ibrahim, MD         
Carl K. Jonokuchi, MD Not yet recruiting
Newbury Park, California, United States, 91320
Contact: Natasha Cox    805-499-3252    NCox.JonokuchiMD@gmail.com   
Principal Investigator: Karl K Jonokuchi, MD         
Venturina Medical Care Not yet recruiting
Thousand Oaks, California, United States, 91360
Contact: Arturo P. Venturina, MD    805-492-1255      
Principal Investigator: Arturo P. Venturina, MD         
Arroyo Oaks Medical Group Not yet recruiting
Thousand Oaks, California, United States, 91360
Contact: Daniel Tavari, DO    805-495-1066      
Contact: Kim         
Principal Investigator: Daniel Tavari, DO         
Dan E. Dardashti, MD Not yet recruiting
Valley Village, California, United States, 91607
Contact: Dan E. Dardashti, MD    818-508-9190    drdinternalmedicine@gmail.com   
Principal Investigator: Dan E. Dardashti, MD         
Advanced Pain Management Not yet recruiting
Vista, California, United States, 92083
Contact: Anuj Gupta, MD    619-330-8771    drgupta@sdpainmanagement.com   
Principal Investigator: Anuj Gupta, MD         
CA Spine & Pain Institute Not yet recruiting
West Hills, California, United States, 91307
Contact: Magued R. Fadly, MD    818-225-0045      
Principal Investigator: Magued R. Fadley, MD         
Woodland Hills Urgent Care Not yet recruiting
Woodland Hills, California, United States, 91364
Contact: Boris Vaisman, MD    818-225-1255    doctor@thedoctorV.com   
Principal Investigator: Boris Vaisman, MD         
Sponsors and Collaborators
Research & Marketing Consultants, Inc.
Investigators
Study Director: Stephen A. Raymond, PhD Research and Marketing Consultants
  More Information

No publications provided

Responsible Party: Research & Marketing Consultants, Inc.
ClinicalTrials.gov Identifier: NCT02195752     History of Changes
Other Study ID Numbers: RMCP001
Study First Received: July 15, 2014
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Research & Marketing Consultants, Inc.:
Compounded pain cream
Ordinary care
Compounding
Topical treatment
Analgesia

Additional relevant MeSH terms:
Acute Pain
Chronic Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014