Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-02 @ 1:07 AM
Study NCT ID:
NCT06954766
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000894', 'term': 'Anti-Inflammatory Agents, Non-Steroidal'}], 'ancestors': [{'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}, {'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000893', 'term': 'Anti-Inflammatory Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D018501', 'term': 'Antirheumatic Agents'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)', 'timeFrame': '6 Weeks', 'description': 'Pain will be measured using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain)'}], 'secondaryOutcomes': [{'measure': 'Change in weight-bearing knee pain measured using the Visual Analog Scale(VAS)', 'timeFrame': '2 weeks, 4 weeks', 'description': 'Pain will be measured using a 10-cm Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst imaginable pain)'}, {'measure': 'Change in total K-WOMAC (Korean Western Ontario and McMaster Universities Osteoarthritis Index) score from baseline', 'timeFrame': '2 weeks, 4 weeks, 6 weeks', 'description': 'The K-WOMAC consists of 24 items, with each item scored on a 5-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe), where higher scores indicate greater symptom severity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CKD-981'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using CKD-981', 'detailedDescription': 'The aim of this pilot study is to evaluate the efficacy and safety of CKD-981 in patients with mild to moderate degenerative knee osteoarthritis who have been experiencing pain more than 8 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients between 40 years and 80 years old\n* Patients who have experiencing knee pain more than 8 weeks\n* VAS more than 40 mm\n* Kellgren and Lawrence grade 2 and 3 in X' ray knee joint\n\nExclusion Criteria:\n\n* Previous knee surgery in affected side\n* Patients with Rheumatoid arthritis, connective tissue disease, Paget's disease\n* Infection of knee joint\n* BMI more than 35kg/m2"}, 'identificationModule': {'nctId': 'NCT06954766', 'briefTitle': 'Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'A Randomized, Double-blind, Sham-controlled, Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981 in Patients With Degenerative Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'A145_01OA2401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expermental group 1', 'description': 'Patients assigned to this group will receive treatment with the medical device CKD-981(1) in combination with a placebo.', 'interventionNames': ['Device: CKD-981(1)', 'Drug: Placebo Drug']}, {'type': 'EXPERIMENTAL', 'label': 'Expermental group 2', 'description': 'Patients assigned to this group will receive treatment with the medical device CKD-981(2) in combination with a placebo.', 'interventionNames': ['Device: CKD-981(2)', 'Drug: Placebo Drug']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham group', 'description': 'Patients assigned to this group will receive treatment with the sham device in combination with a placebo.', 'interventionNames': ['Device: Sham device', 'Drug: Placebo Drug']}, {'type': 'SHAM_COMPARATOR', 'label': 'Reference group', 'description': 'Patients assigned to this group will receive treatment with the sham device in combination with a reference drug.', 'interventionNames': ['Device: Sham device', 'Drug: Reference Drug']}], 'interventions': [{'name': 'CKD-981(1)', 'type': 'DEVICE', 'otherNames': ['Expermental Device 1'], 'description': '20 minutes per day, 5 days a week for 6 weeks.', 'armGroupLabels': ['Expermental group 1']}, {'name': 'CKD-981(2)', 'type': 'DEVICE', 'otherNames': ['Expermental Device 2'], 'description': '20 minutes per day, 5 days a week for 6 weeks.', 'armGroupLabels': ['Expermental group 2']}, {'name': 'Sham device', 'type': 'DEVICE', 'otherNames': ['CKD-981 Sham Device'], 'description': '20 minutes per day, 5 days a week for 6 weeks.', 'armGroupLabels': ['Reference group', 'Sham group']}, {'name': 'Reference Drug', 'type': 'DRUG', 'otherNames': ['NSAIDs'], 'description': 'QD for 6 weeks', 'armGroupLabels': ['Reference group']}, {'name': 'Placebo Drug', 'type': 'DRUG', 'otherNames': ['Placebo for NSAIDs'], 'description': 'QD for 6 weeks', 'armGroupLabels': ['Expermental group 1', 'Expermental group 2', 'Sham group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wŏnju', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung Hoon Kim, M.D, Ph.D', 'role': 'CONTACT', 'email': 'kimrehab@yonsei.ac.kr', 'phone': '033-741-0114'}], 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'centralContacts': [{'name': 'Sung Hoon KIm, M.D, Ph.D', 'role': 'CONTACT', 'email': 'kimrehab@yonsei.ac.kr', 'phone': '033-741-0114'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}