Predictive Markers of the Effects of Opioid Therapy

Chronic Pain Clinical Trial

— ABILITY  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02308306
• Other study ID #: ABILITY
• Status: Completed
• Phase: N/A
• First received: December 2, 2014
• Last updated: May 11, 2016
• Start date: October 2014
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeDenmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research EthicsSlovenia: Ethics Committee
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

• 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.

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Analgesic Treatment Response

Locations

Country	Name	City	State
Belgium	KU Leuven and the Leuven Centre for Algology & Pain Management	Leuven	Pellenberg
Denmark	Department of Rheumatology, Aarhus University Hospital	Aarhus C
Denmark	Friklinikken	Give
Denmark	Hospitalet Valdemar	Ringsted
Slovenia	Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Countries where clinical trial is conducted

Belgium,  Denmark,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 14-days of opioid treatment	No
Primary	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.	After 14 days of opioid treatment	No
Secondary	BPI worst pain in the past week	Change from baseline	Day 14 post-treatment	No
Secondary	BPI least pain in the past week	Change from baseline	Day 14 post-treatment	No
Secondary	BPI current pain in the past week	Change from baseline	Day 14 post-treatment	No
Secondary	BPI pain severity in the past week	Change from baseline	Day 14 post-treatment	No
Secondary	BPI pain interference score	Change from baseline	Day 14 post-treatment	No
Secondary	Improvement score	Proportion with score >4	Day 14 post-treatment	No
Secondary	Concomitant and rescue medication		Until 14 days post-treatment	No
Secondary	Adverse events	Number (%) of the following: Constipation; Dry mouth; Nausea/Vomiting; Sedation; Sweats; Bad dreams; Dysphoria/Delirium; Myoclonus/Seizures; Pruritus/Urticaria; Urinary retention	Until 14 days post-treatment	No

External Links

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