Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2026-03-03 @ 2:20 PM
Study NCT ID:
NCT02308306
Status:
COMPLETED
Last Update Posted:
2016-05-12
First Post:
2014-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Markers of the Effects of Opioid Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2014-12-02', 'studyFirstSubmitQcDate': '2014-12-03', 'lastUpdatePostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of chronic pain assessed by 0-10 numerical rating scale (NRS) scores', 'timeFrame': 'After 14-days of opioid treatment', 'description': '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.'}, {'measure': 'Improvement of health-related quality of life assessed by QLQ-C30 scores', 'timeFrame': 'After 14 days of opioid treatment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'BPI worst pain in the past week', 'timeFrame': 'Day 14 post-treatment', 'description': 'Change from baseline'}, {'measure': 'BPI least pain in the past week', 'timeFrame': 'Day 14 post-treatment', 'description': 'Change from baseline'}, {'measure': 'BPI current pain in the past week', 'timeFrame': 'Day 14 post-treatment', 'description': 'Change from baseline'}, {'measure': 'BPI pain severity in the past week', 'timeFrame': 'Day 14 post-treatment', 'description': 'Change from baseline'}, {'measure': 'BPI pain interference score', 'timeFrame': 'Day 14 post-treatment', 'description': 'Change from baseline'}, {'measure': 'Improvement score', 'timeFrame': 'Day 14 post-treatment', 'description': 'Proportion with score \\>4'}, {'measure': 'Concomitant and rescue medication', 'timeFrame': 'Until 14 days post-treatment'}, {'measure': 'Adverse events', 'timeFrame': 'Until 14 days post-treatment', 'description': 'Number (%) of the following:\n\n1. Constipation\n2. Dry mouth\n3. Nausea/Vomiting\n4. Sedation\n5. Sweats\n6. Bad dreams\n7. Dysphoria/Delirium\n8. Myoclonus/Seizures\n9. Pruritus/Urticaria\n10. Urinary retention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic pain', 'Opioid analgesics', 'Prediction study', 'Pharmaco-EEG'], 'conditions': ['Opioid Analgesic Treatment Response', 'Chronic Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mech-sense.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThe 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.\n\nMarkers 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.\n\nThe 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:\n\n* Pain intensity and unpleasantness\n* Use of rescue analgesics\n* Physical functioning\n* Global improvement and satisfaction with treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pain duration ≥ 3 months.\n* Minimum baseline pain intensity ≥ 4 on a 0-10 numerical rating scale (over the past week).\n* Maximum baseline pain intensity \\< 9 on a 0-10 numerical rating scale (over the past week).\n* Prescribed opioid treatment (ATC: N02)\n* Anticipated to stay on prescribed opioid treatment throughout the study, i.e. \\>14 days.\n* Anticipated to stay on any concomitant non-opioid treatment throughout the study, i.e. \\>14 days.\n* Subject may be male or female, age \\>18 years old.\n* Is willing and able to comply with study procedures as judged by the site investigator.\n* 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.\n\nExclusion Criteria:\n\n* Has a mental incapacity or language barriers precluding adequate understanding of study procedures.\n* 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.\n* Recently received opioids on a daily basis (within the last 10 weeks).\n* Current alcohol or substance abuse, according to the site investigator's medical judgement.\n* 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."}, 'identificationModule': {'nctId': 'NCT02308306', 'acronym': 'ABILITY', 'briefTitle': 'Predictive Markers of the Effects of Opioid Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Predictive Markers of the Effects of Opioid Therapy in Opioid naïve Patients With Chronic Pain: an International, Multi-centre, Observational Cohort Study (ABILITY)', 'orgStudyIdInfo': {'id': 'ABILITY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Opioid analgesics', 'description': '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).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3212', 'city': 'Leuven', 'state': 'Pellenberg', 'country': 'Belgium', 'facility': 'KU Leuven and the Leuven Centre for Algology & Pain Management', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '7323', 'city': 'Give', 'state': 'Give', 'country': 'Denmark', 'facility': 'Friklinikken', 'geoPoint': {'lat': 55.84523, 'lon': 9.23769}}, {'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Department of Rheumatology, Aarhus University Hospital', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}, {'zip': '4100', 'city': 'Ringsted', 'country': 'Denmark', 'facility': 'Hospitalet Valdemar', 'geoPoint': {'lat': 55.4426, 'lon': 11.79011}}, {'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Ljubljana University Medical Centre, Department of Anaesthetics and Surgical Intensive Care', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Asbjørn M Drewes, MD, PhD, DMSci', 'role': 'STUDY_CHAIR', 'affiliation': 'Aalborg University Hospital, Denmark'}, {'name': 'Anne E Olesen, MSc (Pharm), PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aalborg University Hospital, Denmark'}, {'name': 'Kasper Grosen, MHSc, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarhus University / Aarhus University Hospital, Denmark'}, {'name': 'Mogens Pfeiffer-Jensen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University Hospital, Denmark'}, {'name': 'Michael Kamp-Jensen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospitalet Valdemar, Denmark'}, {'name': 'Bart Morlion, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leuven / University Hospitals Leuven, Belgium'}, {'name': 'Gorazd Pozlep, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ljubljana University Medical Centre, Slovenia'}, {'name': 'Torsten Jonsson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospitalet Valdemar, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}