NCT01484301

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
Last Updated

March 20, 2013

Status Verified

March 1, 2013

Enrollment Period

6 months

First QC Date

December 1, 2011

Last Update Submit

March 19, 2013

Conditions

Pain

Keywords

Chronic painOpioidsTolerability

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Family physician and pain medicine specialist practices

You may qualify if:

  • 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.

You may not qualify if:

  • \- Current or previous history of opioid addiction, abuse, or diversion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainChronic Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janssen-Ortho, Canada Clinical Trial

    Janssen-Ortho Inc., Canada

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2011

First Posted

December 2, 2011

Study Start

February 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 20, 2013

Record last verified: 2013-03