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Predictive Markers of the Effects of Opioid Therapy (ABILITY)

11. maj 2016 opdateret af: University of Aarhus

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.

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

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

62

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
    • Pellenberg
      • Leuven, Pellenberg, Belgien, 3212
        • KU Leuven and the Leuven Centre for Algology & Pain Management
  • Danmark
      • Aarhus C, Danmark, 8000
        • Department of Rheumatology, Aarhus University Hospital
      • Give, Danmark, 7323
        • Friklinikken
      • Ringsted, Danmark, 4100
        • Hospitalet Valdemar
  • Slovenien
      • Ljubljana, Slovenien, 1000
        • Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores
Tidsramme: 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.
After 14-days of opioid treatment
Improvement of health-related quality of life assessed by QLQ-C30 scores
Tidsramme: 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.
After 14 days of opioid treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
BPI worst pain in the past week
Tidsramme: Day 14 post-treatment
Change from baseline
Day 14 post-treatment
BPI least pain in the past week
Tidsramme: Day 14 post-treatment
Change from baseline
Day 14 post-treatment
BPI current pain in the past week
Tidsramme: Day 14 post-treatment
Change from baseline
Day 14 post-treatment
BPI pain severity in the past week
Tidsramme: Day 14 post-treatment
Change from baseline
Day 14 post-treatment
BPI pain interference score
Tidsramme: Day 14 post-treatment
Change from baseline
Day 14 post-treatment
Improvement score
Tidsramme: Day 14 post-treatment
Proportion with score >4
Day 14 post-treatment
Concomitant and rescue medication
Tidsramme: Until 14 days post-treatment
Until 14 days post-treatment
Adverse events
Tidsramme: Until 14 days post-treatment

Number (%) of the following:

  1. Constipation
  2. Dry mouth
  3. Nausea/Vomiting
  4. Sedation
  5. Sweats
  6. Bad dreams
  7. Dysphoria/Delirium
  8. Myoclonus/Seizures
  9. Pruritus/Urticaria
  10. Urinary retention
Until 14 days post-treatment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Aarhus

Efterforskere

  • Studiestol: Asbjørn M Drewes, MD, PhD, DMSci, Aalborg University Hospital, Denmark
  • Studieleder: Anne E Olesen, MSc (Pharm), PhD, Aalborg University Hospital, Denmark
  • Studieleder: Kasper Grosen, MHSc, PhD, Aarhus University / Aarhus University Hospital, Denmark
  • Ledende efterforsker: Mogens Pfeiffer-Jensen, MD, PhD, Aarhus University Hospital, Denmark
  • Ledende efterforsker: Michael Kamp-Jensen, MD, PhD, Hospitalet Valdemar, Denmark
  • Ledende efterforsker: Bart Morlion, MD, PhD, University of Leuven / University Hospitals Leuven, Belgium
  • Ledende efterforsker: Gorazd Pozlep, MD, Ljubljana University Medical Centre, Slovenia
  • Ledende efterforsker: Torsten Jonsson, MD, Hospitalet Valdemar, Denmark

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2014

Primær færdiggørelse (Faktiske)

1. september 2015

Studieafslutning (Faktiske)

1. september 2015

Datoer for studieregistrering

Først indsendt

2. december 2014

Først indsendt, der opfyldte QC-kriterier

3. december 2014

Først opslået (Skøn)

4. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ABILITY

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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