Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-12 @ 7:46 AM
Study NCT ID:
NCT05528705
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2022-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigator Initiated Trial to Evaluate Efficacy and Safety of LAENNEC (Human Placenta Hydrolysate) Administered by Ultrasonography Guided Subacromial Bursa Injection in Patients With Shoulder Impingement Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019534', 'term': 'Shoulder Impingement Syndrome'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2022-09-01', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change amoust of VAS (visual analogue scale)', 'timeFrame': 'week 0 and 12'}], 'secondaryOutcomes': [{'measure': 'Change amoust of VAS (visual analogue scale)', 'timeFrame': 'week 1, 2, 3 and 6'}, {'measure': 'Change amoust of SPADI', 'timeFrame': 'week 1, 2, 3, 6 and 12'}, {'measure': 'Change amoust of EQ-5D-5L', 'timeFrame': 'week 1, 2, 3, 6 and 12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Impingement Syndrome']}, 'referencesModule': {'references': [{'pmid': '39754114', 'type': 'DERIVED', 'citation': 'Kim DH, Park MW, Shin HI, Lee BC, Kim DK, Cho CH, Kim YJ. Effectiveness and safety of human placenta hydrolysate injection into subacromial space in patients with shoulder impingement syndrome: a single-blind, randomized trial. BMC Musculoskelet Disord. 2025 Jan 3;26(1):11. doi: 10.1186/s12891-024-08266-4.'}]}, 'descriptionModule': {'briefSummary': 'To patients with shoulder collision syndrome, LAENNEC (Human Placenta Hydrolysate) is administered as an injection in the ultrasonic induction underglone, to evaluate the effectiveness and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At the time of screening, 19 or 70 years\n2. Those who are suspected of rotator cuff lesions or damage due to shoulder pain\n3. Those who are judged to have a shoulder joint disease during screening\n4. Neer test, Hawkins-Kennedy inspection, job test, Painful Arc inspection or resisted showder external rotation test\n5. Those with a significant pain of 30 mm of Visual Analogue Scale (VAS)\n6. Those who can sign a test subject or to comply with the matters required for clinical trials.\n\nExclusion Criteria:\n\n1. A person who appears in the movement of two or more shoulder joints with more than 50% of the joint movement limit on the passive shoulder joint operation scope test.\n2. Those who have confirmed the rupture of the entire layer by ultrasound\n3. Those with serious damage to the shoulders and the past power\n4. Those who have suspected fractures, dislocations, degenerative arthritis, and calcification in the shoulder radiation test in the shoulder radiation test.\n5. Those who complain of shoulder pain due to stroke, spinal cord injury, and other surgery\n6. Those with other shoulder diseases other than fifty dogs (rheumatoid arthritis, osteoarthritis, bone defect injuries, malignant tumors, etc.)\n7. Those who are accompanied by diseases of cervical spine or other upper limbs that have a significant effect on the shoulder\n8. Those who have performed steroid injections in the joint steel within 3 months of participation in clinical trials\n9. Those who have administered anti -inflammatory drugs within two weeks of participation in clinical trials\n10. Those with all other joint diseases that have musculoskeletal diseases that may affect effective evaluation, or that it is impossible to participate in this clinical trial.\n11. Those who are diagnosed with mental illness and taking drugs\n12. Pregnant women and lactation departments, fertility women who are not willing to contraceptive during the clinical trial period\n13. Those who have received medication, oriental medicine, physical therapy, and injection treatment in relation to shoulder pain within the last two weeks 14 Those who are participating in other clinical trials during screening\n\n15\\. Those who determine that other testors are inadequate'}, 'identificationModule': {'nctId': 'NCT05528705', 'acronym': 'PAIN', 'briefTitle': 'Investigator Initiated Trial to Evaluate Efficacy and Safety of LAENNEC (Human Placenta Hydrolysate) Administered by Ultrasonography Guided Subacromial Bursa Injection in Patients With Shoulder Impingement Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'Green Cross Wellbeing'}, 'officialTitle': 'A Randomized, Parallel-group, Placebo-controlled, Single-blind, Investigator Initiated Trial to Evaluate Efficacy and Safety of LAENNEC (Human Placenta Hydrolysate) Administered by Ultrasonography Guided Subacromial Bursa Injection in Patients With Shoulder Impingement Syndrome', 'orgStudyIdInfo': {'id': 'LAEN-PAIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LAENNEC', 'description': '4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment', 'interventionNames': ['Biological: LAENNEC']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.9% Normal saline', 'description': '4ml once a week for 3 weeks of Subacromial spatial administration + conservative treatment', 'interventionNames': ['Other: 0.9% normal saline']}], 'interventions': [{'name': 'LAENNEC', 'type': 'BIOLOGICAL', 'otherNames': ['Human Placenta Hydrolysate'], 'description': 'Subacromial spatial administration', 'armGroupLabels': ['LAENNEC']}, {'name': '0.9% normal saline', 'type': 'OTHER', 'description': 'Subacromial spatial administration', 'armGroupLabels': ['0.9% Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Gwangmyeong', 'country': 'South Korea', 'facility': 'Chung-Ang University Gwangmyeong Hospital', 'geoPoint': {'lat': 37.47722, 'lon': 126.86639}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Cross Wellbeing', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}