Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-02-03 @ 3:21 AM
Study NCT ID:
NCT02612233
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
2015-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-11-17', 'releaseDate': '2020-10-27'}], 'estimatedResultsFirstSubmitDate': '2020-10-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-19', 'studyFirstSubmitDate': '2015-11-18', 'studyFirstSubmitQcDate': '2015-11-20', 'lastUpdatePostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Australian/Canadian Hand Osteoarthritis Index score (AUSCAN)', 'timeFrame': '12 weeks', 'description': 'The AUSCAN measures pain and hand function. Differences between baseline AUSCAN and after treatment will be recorded for each participant to assess for improvement in AUSCAN pain and function score after the trial intervention.'}], 'secondaryOutcomes': [{'measure': 'Brain magnetic resonance imaging (MRI)', 'timeFrame': 'Baseline and 12 weeks after treatment', 'description': 'Changes between baseline MRI and post-treatment after 12 weeks of intervention will be measured using functional neuroimaging to assess pain center activation before and after intervention.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain'], 'conditions': ['Hand Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis of the hands affects millions of people and is a major cause of hand disability and pain. Despite this, there are currently no treatments that delay or halt the development of osteoarthritis. Pain is one of the major symptoms of osteoarthritis and pain management is an important factor to consider in the treatment of this condition. Treatments for pain in osteoarthritis consists of local injections, anti-inflammatory gels or painkillers such as paracetamol. However, most people with osteoarthritis still have pain despite these treatments.', 'detailedDescription': "Recent scientific studies have suggested that people with hand osteoarthritis not only feel pain in their hand joints, they also appear to have increased signals in their brain pain processing pathways. At St George's, University of London, the investigators have been conducting studies to find out which brain regions are activated in subjects with hand osteoarthritis. The investigators have found that certain brain regions (thalamus, insula, cingulate and somatosensory cortex) are activated during painful tasks in patients with hand osteoarthritis but not in healthy people. In this study the investigators will establish whether drugs that inhibit pain processing pathways in the brain can help. Patients who are still having pain despite their usual painkillers will be randomly divided into 3 groups: one group will receive a placebo, the other 2 groups will receive one of two different drugs, duloxetine or pregabalin. Participants will be assessed using questionnaires and a brain scan (functional MRI) before and after 13 weeks of taking the tablets. This study will help us to understand the ways in which people feel pain in osteoarthritis. If our trial proves successful,drugs that dampen central pain pathways could be used in combination with local pain-relieving drugs to improve treatment and reduce disability in patients with hand osteoarthritis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants fulfilling the American College of Rheumatology (ACR) criteria for the diagnosis of hand osteoarthritis\n* Participants with hand osteoarthritis presenting to rheumatology outpatient clinics and primary care.\n* Participants will be right or left handed\n* Male or female\n* Age between 40 and 75\n* Participants will be on usual care for hand osteoarthritis including paracetamol and/or non-steroidal anti-inflammatory drugs\n\nExclusion Criteria:\n\n* Participants with other rheumatological diagnoses e.g. rheumatoid arthritis\n* Current or planned pregnancy\n* Contraindications to duloxetine or pregabalin\n* History of depression\n* Recent surgery\n* Previous use of duloxetine and/or pregabalin'}, 'identificationModule': {'nctId': 'NCT02612233', 'acronym': 'DUPRO', 'briefTitle': 'Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin', 'organization': {'class': 'OTHER', 'fullName': "St George's, University of London"}, 'officialTitle': 'Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin', 'orgStudyIdInfo': {'id': '11.0126'}, 'secondaryIdInfos': [{'id': '2011-003803-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pregabalin', 'description': 'Pregabalin 150mg ON week 1 increased to Pregabalin 300mg ON weeks 2-11 then decrease to Pregabalin 150mg ON week 12 then STOP', 'interventionNames': ['Drug: Pregabalin or Duloxetine or Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Duloxetine', 'description': 'Duloxetine 30mg ON week 1 increase to Duloxetine 60mg weeks 2-11 then decrease to Duloxetine 30mg ON week 12 then STOP', 'interventionNames': ['Drug: Pregabalin or Duloxetine or Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 capsule ON week 1- increase to 2 capsules ON week 2-11 then decrease to 1 capsule ON week 12 then STOP.', 'interventionNames': ['Drug: Pregabalin or Duloxetine or Placebo']}], 'interventions': [{'name': 'Pregabalin or Duloxetine or Placebo', 'type': 'DRUG', 'otherNames': ['DUPRO Capsules'], 'description': 'This is a randomized, double blind placebo controlled trial with a head-to-head comparison of duloxetine vs pregabalin vs placebo over-encapsulated to prevent unblinding of treatment arm', 'armGroupLabels': ['Duloxetine', 'Placebo', 'Pregabalin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17 ORE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hotung Centre for Musculoskeletal Diseases', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Nidhi Sofat, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St George's, University of London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St George's, University of London", 'class': 'OTHER'}, 'collaborators': [{'name': 'Rosetrees Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-10-27', 'type': 'RELEASE'}, {'date': '2020-11-17', 'type': 'RESET'}], 'unpostedResponsibleParty': "St George's, University of London"}}}}