- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01484301
Impact of Tolerability Issues on Chronic Pain
March 19, 2013 updated by: Janssen-Ortho Inc., Canada
The Impact of Opioid Tolerability Outcomes on the Management of Chronic Pain
The purpose of this study was to assess the impact of opioid tolerability-related issues experienced by Canadian chronic pain patients.
Approximately 170 patients were enrolled from 16 recruiting centers across Canada.
Eligible patients had a diagnosis of non-malignant, chronic pain requiring continuous use of strong opioids (>=4 days per week).
Recruitment was initiated by physicians during routine care appointments at family or pain medicine practices.
Patients were then directed to a website where they provided consent and completed an anonymized, password-protected, web-based survey that could be completed at home.
This weekly online questionnaire was designed to document their chronic pain experience over a 12-week period.
At the end of the 12-week study, physicians were asked to retrospectively complete information about pain treatments, over-the-counter (OTC) medication use for pain and opioid-related gastrointestinal (GI) side effects, as well as co-morbid conditions for each patient.
Study Overview
Status
Completed
Conditions
Detailed Description
This was a multi-center, non-interventional, observational study of patients receiving opioid treatment for chronic pain.
Relevant Canadian data such as pain severity, treatment adherence, medical resource utilization, and interference with activities of daily living were collected to evaluate the impact of opioid-related side effects in chronic pain.
The focus was mainly on side effects of the gastro-intestinal (GI) system.
The study was divided into 2 components: a prospective, web-based patient survey and a physician-completed, retrospective chart review at study end.
The patient survey included one baseline and 12 weekly follow-up surveys.
The purpose of the web survey was to collect accurate data from the patient, particularly for outcomes that are not typically recorded in the medical charts, such as weekly pain severity scores, treatment adherence, and patient-reported outcomes (PROs), like medical resource use and impact on activities of daily living.
To capture treatment management decisions, a retrospective chart review was performed by the physician or designee at the end of the 12-week period for each patient who completed baseline and at least one follow-up survey.
Data collected included prescribed opioid and non-opioid medications for pain control, GI side effect treatments, co-morbid conditions/medications, and medical history.
Eligible patients were offered an invitation letter at their usual care visit, where the study website was provided via weblink.
Patients were nominally reimbursed for completing the survey.
This study was reviewed and approved by an independent Ethics Committee, and informed consent was obtained from all patients.
There was no study treatment, since this was a non-interventional, observational study that did not evaluate any J&J product; the duration of the study was 12 weeks of observation.
Study Type
Observational
Enrollment (Actual)
165
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
Probability Sample
Study Population
Family physician and pain medicine specialist practices
Description
Inclusion Criteria:
- Chronic pain of non-malignant origin (nociceptive, neuropathic or mixed pain types)
- Opioid requirement >=4 days per week, including new to opioids (<3 months exposure), opioid experienced (>3 months exposure), non-opioids or weak opioids (e.g., NSAIDS or Tramacet) for breakthrough or adjunctive use only
- Internet access; read/understand English or French.
Exclusion Criteria:
- Current or previous history of opioid addiction, abuse, or diversion
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Janssen-Ortho, Canada Clinical Trial, Janssen-Ortho Inc., Canada
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
February 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
December 1, 2011
First Submitted That Met QC Criteria
December 1, 2011
First Posted (Estimate)
December 2, 2011
Study Record Updates
Last Update Posted (Estimate)
March 20, 2013
Last Update Submitted That Met QC Criteria
March 19, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR100408
- NOCOMPOUNDNAP4001 (Other Identifier: Janssen-Ortho, Canada)
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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