Opioid Analgesic Treatment ResponseABILITYNCT02308306
Predictive Markers of the Effects of Opioid Therapy
An observational study of Opioid Analgesic Treatment Response and Chronic Pain, run by University of Aarhus at 5 sites in 3 countries.
Trial summary
The overall goal of the ABILITY study is to help improve pain diagnostics and treatment by developing an implementable clinical computerised decision support system based on individual patient characteristics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Analgesic Treatment Response, Chronic Pain
- How many people
- 62 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Oct 2014to Sep 2015
- 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: Subjects with an insufficiently treated chronic pain condition (with non-opioids ± adjuvants), and expected to benefit from the administration of opioids (as necessary) to obtain freedom from pain.
Who may be able to join
- Pain duration ≥ 3 months.
- Minimum baseline pain intensity ≥ 4 on a 0-10 numerical rating scale (over the past week).
- Maximum baseline pain intensity < 9 on a 0-10 numerical rating scale (over the past week).
- Prescribed opioid treatment (ATC: N02)
- Anticipated to stay on prescribed opioid treatment throughout the study, i.e. >14 days.
- Anticipated to stay on any concomitant non-opioid treatment throughout the study, i.e. >14 days.
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- Subject may be male or female, age >18 years old.
- Is willing and able to comply with study procedures as judged by the site investigator.
- Subject has voluntarily signed and dated the study-specific informed consent form, approved by an Independent Ethics Committee, after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent form must be signed before any study-specific procedures are performed.
Who cannot join
- Has a mental incapacity or language barriers precluding adequate understanding of study procedures.
- Is considered by the site investigator unsuitable to participate in the study for any other reason, for instance due to a significant serious underlying condition.
- Recently received opioids on a daily basis (within the last 10 weeks).
- Current alcohol or substance abuse, according to the site investigator's medical judgement.
- Is anticipated to undergo a painful procedure(s) (e.g. surgery) during the study, which can interfere with the experience of the chronic pain condition for which the subject is to receive opioids.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Denmark3 sites
Department of Rheumatology, Aarhus University Hospital
Aarhus C, 8000
Friklinikken
Give, Give, 7323
Hospitalet Valdemar
Ringsted, 4100
Belgium1 site
KU Leuven and the Leuven Centre for Algology & Pain Management
Leuven, Pellenberg, 3212
Slovenia1 site
Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care
Ljubljana, 1000
About this study
Official title: Predictive Markers of the Effects of Opioid Therapy in Opioid naïve Patients With Chronic Pain: an International, Multi-centre, Observational Cohort Study (ABILITY)
The overall goal of the ABILITY study is to help improve pain diagnostics and treatment by developing an implementable clinical computerised decision support system based on individual patient characteristics.
The investigators hypothesize that successful pain control with opioids can be predicted before treatment initiation with advanced data analyses of data originating from pre-treatment EEG, QST and pain-related catastrophic thinking.
Read more
The primary objective of this study is the identification of markers that can be used to individualize treatment recommendations, i.e. to reliably predict the response of pain to opioids.
Markers are selected among the most promising data and machine-learning methods are used for the prediction. This includes determining the associations between a battery of selected pre-treatment clinical predictive markers and the analgesic effect of opioid treatment in opioid naïve chronic pain patients, including indication and responder identification.
The key secondary objectives are as follows: to investigate pre-treatment clinical predictive markers as predictors of opioid treatment efficacy and effectiveness in terms of the following:
- Pain intensity and unpleasantness
- Use of rescue analgesics
- Physical functioning
- Global improvement and satisfaction with treatment
- Conditions
- Opioid Analgesic Treatment Response, Chronic Pain
- Keywords
- Chronic pain, Opioid analgesics, Prediction study, Pharmaco-EEG
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Opioid analgesics | Opioid treatment is determined, prescribed, modified and discontinued at the sole discretion of the treating physician at each research site; regardless of generic name, manufacturer, constituent components, route of administration, and dosing schedule (including titration and run-in periods). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores
The absolute and percentage change from baseline in ratings of average pain in the past week at Day 14. Of note, a percentage change of ≥30% is considered clinically significant.
Measured: After 14-days of opioid treatment
Improvement of health-related quality of life assessed by QLQ-C30 scores
The absolute and percentage change from baseline in ratings of health-related quality of life in the past week at Day 14. A subjectively significant change in QLQ-C30 scores is one that is ≥10 from baseline.
Measured: After 14 days of opioid treatment
Secondary outcomes (8)
BPI worst pain in the past week
Change from baseline
Measured: Day 14 post-treatment
BPI least pain in the past week
Change from baseline
Measured: Day 14 post-treatment
BPI current pain in the past week
Change from baseline
Measured: Day 14 post-treatment
BPI pain severity in the past week
Change from baseline
Measured: Day 14 post-treatment
BPI pain interference score
Change from baseline
Measured: Day 14 post-treatment
Improvement score
Proportion with score >4
Measured: Day 14 post-treatment
Concomitant and rescue medication
Measured: Until 14 days post-treatment
Adverse events
Number (%) of the following:
- Constipation
- Dry mouth
- Nausea/Vomiting
- Sedation
- Sweats
- Bad dreams
- Dysphoria/Delirium
- Myoclonus/Seizures
- Pruritus/Urticaria
- Urinary retention
Measured: Until 14 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Analgesic Treatment ResponseStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asbjørn M Drewes, MD, PhD, DMSci, Study chair, Aalborg University HospitalAnne E Olesen, MSc (Pharm), PhD, Study director, Aalborg University HospitalKasper Grosen, MHSc, PhD, Study director, Aarhus University / Aarhus University Hospital, DenmarkMogens Pfeiffer-Jensen, MD, PhD, Principal investigator, Aarhus University HospitalMichael Kamp-Jensen, MD, PhD, Principal investigator, Hospitalet Valdemar, DenmarkBart Morlion, MD, PhD, Principal investigator, University of Leuven / University Hospitals Leuven, BelgiumGorazd Pozlep, MD, Principal investigator, Ljubljana University Medical Centre, SloveniaTorsten Jonsson, MD, Principal investigator, Hospitalet Valdemar, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308306
- Sponsor's protocol ID
- ABILITY
- Acronym
- ABILITY
- Status last verified
- May 2016
- First submitted
- 2 Dec 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Markers of the Effects of Opioid Therapy in Opioid naïve Patients With Chronic Pain: an International, Multi-centre, Observational Cohort Study (ABILITY)
- ClinicalTrials.gov ID
- NCT02308306
- Acronym / sponsor ID
- ABILITY / ABILITY
- Conditions
- Opioid Analgesic Treatment Response, Chronic Pain
- Keywords
- Chronic pain, Opioid analgesics, Prediction study, Pharmaco-EEG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Dec 2014 (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 overall goal of the ABILITY study is to help improve pain diagnostics and treatment by developing an implementable clinical computerised decision support system based on individual patient characteristics.
The investigators hypothesize that successful pain control with opioids can be predicted before treatment initiation with advanced data analyses of data originating from pre-treatment EEG, QST and pain-related catastrophic thinking.
The primary objective of this study is the identification of markers that can be used to individualize treatment recommendations, i.e. to reliably predict the response of pain to opioids.
Markers are selected among the most promising data and machine-learning methods are used for the prediction. This includes determining the associations between a battery of selected pre-treatment clinical predictive markers and the analgesic effect of opioid treatment in opioid naïve chronic pain patients, including indication and responder identification.
The key secondary objectives are as follows: to investigate pre-treatment clinical predictive markers as predictors of opioid treatment efficacy and effectiveness in terms of the following:
- Pain intensity and unpleasantness
- Use of rescue analgesics
- Physical functioning
- Global improvement and satisfaction with treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Opioid analgesics | – | –Opioid treatment is determined, prescribed, modified and discontinued at the sole discretion of the treating physician at each research site; regardless of generic name, manufacturer, constituent components, route of administration, and dosing schedule (including titration and run-in periods). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with an insufficiently treated chronic pain condition (with non-opioids ± adjuvants), and expected to benefit from the administration of opioids (as necessary) to obtain freedom from pain.
Key inclusion criteria (9 listed)
- Pain duration ≥ 3 months.
- Minimum baseline pain intensity ≥ 4 on a 0-10 numerical rating scale (over the past week).
- Maximum baseline pain intensity < 9 on a 0-10 numerical rating scale (over the past week).
- Prescribed opioid treatment (ATC: N02)
- Anticipated to stay on prescribed opioid treatment throughout the study, i.e. >14 days.
Key exclusion criteria (5 listed)
- Has a mental incapacity or language barriers precluding adequate understanding of study procedures.
- Is considered by the site investigator unsuitable to participate in the study for any other reason, for instance due to a significant serious underlying condition.
- Recently received opioids on a daily basis (within the last 10 weeks).
- Current alcohol or substance abuse, according to the site investigator's medical judgement.
- Is anticipated to undergo a painful procedure(s) (e.g. surgery) during the study, which can interfere with the experience of the chronic pain condition for which the subject is to receive opioids.
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
Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores
Time frame: After 14-days of opioid treatment
The absolute and percentage change from baseline in ratings of average pain in the past week at Day 14. Of note, a percentage change of ≥30% is considered clinically significant.
Improvement of health-related quality of life assessed by QLQ-C30 scores
Time frame: After 14 days of opioid treatment
The absolute and percentage change from baseline in ratings of health-related quality of life in the past week at Day 14. A subjectively significant change in QLQ-C30 scores is one that is ≥10 from baseline.
8 secondary outcomes
BPI worst pain in the past week
Time frame: Day 14 post-treatment
BPI least pain in the past week
Time frame: Day 14 post-treatment
BPI current pain in the past week
Time frame: Day 14 post-treatment
BPI pain severity in the past week
Time frame: Day 14 post-treatment
BPI pain interference score
Time frame: Day 14 post-treatment
Improvement score
Time frame: Day 14 post-treatment
Concomitant and rescue medication
Time frame: Until 14 days post-treatment
Adverse events
Time frame: Until 14 days post-treatment
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 12 May 2016.
- Related InfoLink provided by the sponsor.
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.
Asbjørn M Drewes, MD, PhD, DMSci study chair
Aalborg University Hospital
Anne E Olesen, MSc (Pharm), PhD study director
Aalborg University Hospital
Kasper Grosen, MHSc, PhD study director
Aarhus University / Aarhus University Hospital, Denmark
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Analgesic Treatment Response and Chronic Pain, run by University of Aarhus at 5 sites in 3 countries.
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 9 inclusion and 5 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Belgium, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores (time frame: After 14-days of opioid treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 12 May 2016.