Status:
COMPLETED
Predictive Markers of the Effects of Opioid Therapy
Lead Sponsor:
University of Aarhus
Conditions:
Opioid Analgesic Treatment Response
Chronic Pain
Eligibility:
All Genders
18+ years
Brief 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 charact...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02308306
Start Date
October 1 2014
End Date
September 1 2015
Last Update
May 12 2016
Active Locations (5)
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1
KU Leuven and the Leuven Centre for Algology & Pain Management
Leuven, Pellenberg, Belgium, 3212
2
Friklinikken
Give, Give, Denmark, 7323
3
Department of Rheumatology, Aarhus University Hospital
Aarhus C, Denmark, 8000
4
Hospitalet Valdemar
Ringsted, Denmark, 4100