PainNCT01484301
Impact of Tolerability Issues on Chronic Pain
An observational study of Pain, run by Janssen-Ortho Inc., Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Family physician and pain medicine specialist practices
Who may be able to join
- 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.
Who cannot join
- Current or previous history of opioid addiction, abuse, or diversion
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Keywords
- Chronic pain, Opioids, Tolerability
- Medical subject headings
- Pain, Chronic Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startFeb 2010
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Ortho Inc., Canada
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Ortho, Canada Clinical Trial, Study director, Janssen-Ortho Inc., Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484301
- Sponsor's protocol ID
- CR100408
- Other IDs
- NOCOMPOUNDNAP4001
- Status last verified
- Mar 2013
- First submitted
- 1 Dec 2011
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Opioid Tolerability Outcomes on the Management of Chronic Pain
- ClinicalTrials.gov ID
- NCT01484301
- Acronym / sponsor ID
- CR100408
- Conditions
- Pain
- Keywords
- Chronic pain, Opioids, Tolerability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Janssen-Ortho Inc., CanadaIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Family physician and pain medicine specialist practices
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Current or previous history of opioid addiction, abuse, or diversion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Ortho, Canada Clinical Trial study director
Janssen-Ortho Inc., Canada
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Janssen-Ortho Inc., Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013; AzTrials last refreshed its copy on 6 Nov 2026.