Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-10 @ 4:47 AM
Study NCT ID:
NCT05986292
Status:
RECRUITING
Last Update Posted:
2025-11-05
First Post:
2023-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-11', 'size': 6335457, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_005.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-16T09:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2023-08-01', 'studyFirstSubmitQcDate': '2023-08-01', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Were Allocated to Each ISA', 'timeFrame': 'Baseline, Up to Week 8'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee', 'Diabetic Neuropathic Pain', 'Chronic Low-back Pain']}, 'referencesModule': {'references': [{'pmid': '39430683', 'type': 'DERIVED', 'citation': 'Knopp KL, Downing AM, Anthony L, Chaterjee S, Price K, Sparks J. An innovative phase 2 chronic pain master protocol design to assess novel mechanisms in multiple pain types. Pain Rep. 2024 Oct 16;9(6):e1203. doi: 10.1097/PR9.0000000000001203. eCollection 2024 Dec.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.', 'detailedDescription': 'The chronic pain master protocol (CPMP) establishes entry criteria and includes DSA for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. The DSA have specific study elements to appropriately define the target population and unique scales for assessment. Also, the master protocol governs ISAs that may start independently of other ISAs as interventions become available for clinical testing.\n\nNote: Results for all outcomes are posted in the intervention records. No need for duplication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have a visual analog scale (VAS) pain value \\>40 and \\<95 at screening and prerandomization screening.\n* have a history of daily pain for at least 12 weeks based on participant report or medical history\n* have a value of ≤30 on the pain catastrophizing scale\n* have a body mass index \\<40 kilogram/square meter (kg/m²) (inclusive)\n* are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation.\n* are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study\n\nExclusion Criteria:\n\n* have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia\n* have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques)\n* have surgery planned during the study for any reason, related or not to the disease state under evaluation.\n* have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.\n* have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.\n* have fibromyalgia\n* have substance use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders (5th edition; DSM-5; American Psychiatric Association)\n* have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.\n* have a positive human immunodeficiency virus (HIV) test result at screening\n* have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.'}, 'identificationModule': {'nctId': 'NCT05986292', 'acronym': 'CPMP', 'briefTitle': 'A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain', 'orgStudyIdInfo': {'id': '17511'}, 'secondaryIdInfos': [{'id': 'H0P-MC-CPMP', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3016859 Osteoarthritis ISA', 'description': 'Participants are randomized to receive either active LY3016859 or matching placebo', 'interventionNames': ['Drug: LY3016859 ISA', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3016859 Diabetic Neuropathic Pain ISA', 'description': 'Participants are randomized to receive either active LY3016859 or matching placebo', 'interventionNames': ['Drug: LY3016859 ISA', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3016859 Chronic Back Pain ISA', 'description': 'Participants are randomized to receive either active LY3016859 or matching placebo', 'interventionNames': ['Drug: LY3016859 ISA', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3556050 Osteoarthritis ISA', 'description': 'Participants are randomized to receive either active LY3556050 or matching placebo', 'interventionNames': ['Drug: LY3556050 ISA', 'Drug: Placebo Oral']}, {'type': 'EXPERIMENTAL', 'label': 'LY3556050 Diabetic Neuropathic Pain ISA', 'description': 'Participants are randomized to receive either active LY3556050 or matching placebo', 'interventionNames': ['Drug: LY3556050 ISA', 'Drug: Placebo Oral']}, {'type': 'EXPERIMENTAL', 'label': 'LY3556050 Chronic Back Pain ISA', 'description': 'Participants are randomized to receive either active LY3556050 or matching placebo', 'interventionNames': ['Drug: LY3556050 ISA', 'Drug: Placebo Oral']}, {'type': 'EXPERIMENTAL', 'label': 'LY3526318 Osteoarthritis ISA', 'description': 'Participants are randomized to receive either active LY3526318 or matching placebo', 'interventionNames': ['Drug: LY3526318 ISA', 'Drug: Placebo Oral']}, {'type': 'EXPERIMENTAL', 'label': 'LY3526318 Diabetic Neuropathic Pain ISA', 'description': 'Participants are randomized to receive either active LY3526318 or matching placebo', 'interventionNames': ['Drug: LY3526318 ISA', 'Drug: Placebo Oral']}, {'type': 'EXPERIMENTAL', 'label': 'LY3526318 Chronic Back Pain ISA', 'description': 'Participants are randomized to receive either active LY3526318 or matching placebo', 'interventionNames': ['Drug: LY3526318 ISA', 'Drug: Placebo Oral']}, {'type': 'EXPERIMENTAL', 'label': 'LY3857210 Osteoarthritis ISA', 'description': 'Participants are randomized to receive either active LY3857210 or matching placebo', 'interventionNames': ['Drug: LY3857210 ISA', 'Drug: Placebo Oral']}, {'type': 'EXPERIMENTAL', 'label': 'LY3857210 Diabetic Neuropathic Pain ISA', 'description': 'Participants are randomized to receive either active LY3857210 or matching placebo', 'interventionNames': ['Drug: LY3857210 ISA', 'Drug: Placebo Oral']}, {'type': 'EXPERIMENTAL', 'label': 'LY3857210 Chronic Back Pain ISA', 'description': 'Participants are randomized to receive either active LY3857210 or matching placebo', 'interventionNames': ['Drug: LY3857210 ISA', 'Drug: Placebo Oral']}], 'interventions': [{'name': 'LY3016859 ISA', 'type': 'DRUG', 'description': 'Administered intravenously (IV)', 'armGroupLabels': ['LY3016859 Chronic Back Pain ISA', 'LY3016859 Diabetic Neuropathic Pain ISA', 'LY3016859 Osteoarthritis ISA']}, {'name': 'LY3556050 ISA', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3556050 Chronic Back Pain ISA', 'LY3556050 Diabetic Neuropathic Pain ISA', 'LY3556050 Osteoarthritis ISA']}, {'name': 'LY3526318 ISA', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3526318 Chronic Back Pain ISA', 'LY3526318 Diabetic Neuropathic Pain ISA', 'LY3526318 Osteoarthritis ISA']}, {'name': 'LY3857210 ISA', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['LY3857210 Chronic Back Pain ISA', 'LY3857210 Diabetic Neuropathic Pain ISA', 'LY3857210 Osteoarthritis ISA']}, {'name': 'Placebo Oral', 'type': 'DRUG', 'description': 'Placebo administered orally', 'armGroupLabels': ['LY3526318 Chronic Back Pain ISA', 'LY3526318 Diabetic Neuropathic Pain ISA', 'LY3526318 Osteoarthritis ISA', 'LY3556050 Chronic Back Pain ISA', 'LY3556050 Diabetic Neuropathic Pain ISA', 'LY3556050 Osteoarthritis ISA', 'LY3857210 Chronic Back Pain ISA', 'LY3857210 Diabetic Neuropathic Pain ISA', 'LY3857210 Osteoarthritis ISA']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo administered IV', 'armGroupLabels': ['LY3016859 Chronic Back Pain ISA', 'LY3016859 Diabetic Neuropathic Pain ISA', 'LY3016859 Osteoarthritis ISA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'role': 'CONTACT', 'phone': '205-327-1077'}, {'name': 'David DeAtkine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Central Research Associates', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Simon Williamson Clinic', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85306', 'city': 'Glendale', 'state': 'Arizona', 'status': 'COMPLETED', 'country': 'United 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