Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-31 @ 4:19 PM
Study NCT ID:
NCT03806205
Status:
UNKNOWN
Last Update Posted:
2019-01-16
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009934', 'term': 'Organization and Administration'}], 'ancestors': [{'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'adherence', 'timeFrame': '6-8 weeks', 'description': 'We will calculate adherence with medication use'}, {'measure': 'pain relief rate', 'timeFrame': '6-8 weeks', 'description': 'We will calculate the pain relief rate on all participants'}], 'secondaryOutcomes': [{'measure': 'womac score', 'timeFrame': '6-8 weeks', 'description': 'We will calculate the womac score on all participants'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee osteoarthritis pain; Adherence; Diclofenac; Follow up'], 'conditions': ['To Investigate the Effect of Diclofenac on Pain Control of Knee Osteoarthritis and the Relationship Between Pain Relief and Medicine Adherence']}, 'referencesModule': {'references': [{'pmid': '26997557', 'type': 'BACKGROUND', 'citation': 'da Costa BR, Reichenbach S, Keller N, Nartey L, Wandel S, Juni P, Trelle S. RETRACTED: Effectiveness of non-steroidal anti-inflammatory drugs for the treatment of pain in knee and hip osteoarthritis: a network meta-analysis. Lancet. 2016 May 21;387(10033):2093-2105. doi: 10.1016/S0140-6736(16)30002-2. Epub 2016 Mar 18.', 'retractions': [{'pmid': '28699579', 'source': 'Lancet. 2017 Jul 8;390(10090):109'}]}]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of dichloride on pain control of knee osteoarthritis and the relationship between pain relief and medicine adherence. To evaluate the pain relief rate of patients with different initial pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* According to the OA diagnostic criteria of knee joint, the side with higher WOMAC score is defined as observing knee joint for patients with both knees conforming to OA diagnostic criteria.\n\n 1. Repeated knee pain in the past month\n 2. X-ray showed narrowing of articular space, subchondral sclerosis and/or cystic degeneration, and formation of osteophyte at articular margin.\n 3. Joint fluid (\\> 2 times) is cool and sticky, WBC \\< 2000/ml\n 4. Age over 40\n 5. Morning stiffness less than 30 minutes\n 6. Bone fricative (sensation) during exercise According to 1+2 or 1+3+5+6 or 1+4+5+6, OA of knee joint can be diagnosed.\n 7. The informed consent has been signed\n\nExclusion Criteria:\n\n* (1) Joint pain caused by other causes (infection, hip, lumbar and other diseases) (2) Secondary arthritis (rheumatoid arthritis, ankylosing spondylitis, etc.) (3) Severe internal medical complications and other inability to participate in the research (4) Pain in other parts exceeds joint pain (5) Contraindications to diclofenac use: active peptic ulcer/allergy/induced asthma (6) Assessment may not complete the study'}, 'identificationModule': {'nctId': 'NCT03806205', 'briefTitle': 'Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Efficacy Management and Adherence Evaluation of Diclofenac in the Treatment of Knee Osteoarthritis Pain', 'orgStudyIdInfo': {'id': 'PekingUPHmed'}}, 'armsInterventionsModule': {'interventions': [{'name': 'regular follow-up', 'type': 'OTHER', 'otherNames': ['supervision'], 'description': 'we give a regular follow-up and supervision on the study group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Xicheng District', 'country': 'China', 'contacts': [{'name': 'Yudian Qiu, M.D.', 'role': 'CONTACT'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yudian Qiu, M.D.', 'role': 'CONTACT', 'email': '1210301417@pku.edu.cn', 'phone': '+8613381150519'}, {'name': 'Jianhao Lin, M.D.', 'role': 'CONTACT', 'email': 'linjianhao@pkuph.edu.cn'}], 'overallOfficials': [{'name': 'Jianhao Lin, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Peking University People's Hospital"}, {'name': 'Yudian Qiu, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}