Impact of Tolerability Issues on Chronic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01484301
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : March 20, 2013
Information provided by (Responsible Party):
Janssen-Ortho Inc., Canada

Brief Summary:
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.

Condition or disease

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
Actual Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Opioid Tolerability Outcomes on the Management of Chronic Pain
Study Start Date : February 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Family physician and pain medicine specialist practices

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01484301

Sponsors and Collaborators
Janssen-Ortho Inc., Canada
Study Director: Janssen-Ortho, Canada Clinical Trial Janssen-Ortho Inc., Canada

Responsible Party: Janssen-Ortho Inc., Canada Identifier: NCT01484301     History of Changes
Other Study ID Numbers: CR100408
NOCOMPOUNDNAP4001 ( Other Identifier: Janssen-Ortho, Canada )
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013

Keywords provided by Janssen-Ortho Inc., Canada:
Chronic pain

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