Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-29 @ 5:18 PM
Study NCT ID:
NCT05411861
Status:
COMPLETED
Last Update Posted:
2023-01-11
First Post:
2022-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Operative Pain and Opioid Reduction Trial After Bunionectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006215', 'term': 'Hallux Valgus'}, {'id': 'D000071378', 'term': 'Bunion'}], 'ancestors': [{'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018712', 'term': 'Analgesics, Non-Narcotic'}], 'ancestors': [{'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': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Separate blinded and unblinded study teams'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Bunion Surgery'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2022-06-07', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC72', 'timeFrame': '72 hours post-operative', 'description': 'Pain score through 72 hours post-operative'}], 'secondaryOutcomes': [{'measure': 'Opioid use (MME)', 'timeFrame': '72 hours post-operative', 'description': 'Opioid use through 72 hours post-operative'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hallux Valgus and Bunion']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.', 'detailedDescription': 'Near the completion of surgery, a single dose of study drug (CPL-01, saline placebo, or ropivacaine HCl) will be infiltrated. Subjects will remain in the hospital/research facility for a minimum of 72 hours after the start of study drug administration to undergo postoperative assessments. Subjects will return to the study site on Day 7 to complete follow up assessments, on Day 28 for follow-up assessments including an X-Ray, and on Day 42 for the end-of-study (EOS) visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be willing and able to sign the informed consent form (ICF) prior to study participation\n* In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and ASA Class I or II at the time of randomization\n* Plan to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries\n* Have a BMI ≤ 39 kg/m2\n\nExclusion Criteria:\n\n* Previous unilateral simple bunionectomy\n* Has a planned concurrent surgical procedure that may impact pain scores, rescue medication use, or ability to fulfill the requirements of the protocol\n* Concurrent painful condition\n* Active skin disease or other clinically significant abnormality at the anticipated surgical site that could interfere with the planned surgery\n* Known hypersensitivity or known allergy, as determined by the Investigator, to the ingredients (i.e., excipients) of the study drug or any peri- or postoperative medications used in this study\n* History or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments\n* History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency\n* History or evidence of impaired liver function (e.g., ALT \\> 3 × upper limit of normal \\[ULN\\] or total bilirubin \\> 2 × ULN), active hepatic disease, or cirrhosis\n* History or evidence of impaired renal function (e.g., creatinine \\> 1.5 × ULN)\n* History of malignancy in the past year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized in situ carcinoma of the cervix\n* Has or has had active COVID-19 infection within 3 months prior to surgery'}, 'identificationModule': {'nctId': 'NCT05411861', 'acronym': 'MERIT-2', 'briefTitle': 'Post-Operative Pain and Opioid Reduction Trial After Bunionectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cali Pharmaceuticals LLC'}, 'officialTitle': 'Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate Safety, Efficacy, and PK of CPL-01 in Post-Op Pain After Unilateral Distal First Metatarsal Bunionectomy + Osteotomy', 'orgStudyIdInfo': {'id': 'CPL-01-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CPL-01', 'description': 'Low dose of CPL-01', 'interventionNames': ['Drug: Analgesic Non Narcotic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine HCl', 'description': 'Low dose of Ropivacaine HCl', 'interventionNames': ['Drug: Analgesic Non Narcotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Low volume of placebo', 'interventionNames': ['Drug: Analgesic Non Narcotic']}], 'interventions': [{'name': 'Analgesic Non Narcotic', 'type': 'DRUG', 'otherNames': ['Infiltration of local analgesic'], 'description': 'Injection of protocol-specified volume of local analgesic', 'armGroupLabels': ['CPL-01', 'Placebo', 'Ropivacaine HCl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Research Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Trovare Clinical Research', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Jean Brown Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Erol Onel', 'role': 'STUDY_CHAIR', 'affiliation': 'Cali Biosciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cali Pharmaceuticals LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}