Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-04 @ 1:41 AM
Study NCT ID:
NCT06423703
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589289', 'term': "6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amine"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-05-16', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Respiratory Safety Events', 'timeFrame': '1-7 Days'}], 'primaryOutcomes': [{'measure': 'Pain NRS area under the curve: cebranopadol vs. placebo', 'timeFrame': '2-48 hours'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects who require opioid rescue medication', 'timeFrame': '1-7 Days'}, {'measure': 'Global Assessment of Satisfaction', 'timeFrame': '1-7 Days'}, {'measure': 'Total oxycodone rescue consumption', 'timeFrame': '1-7 Days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bunionectomy'], 'conditions': ['Acute Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.', 'detailedDescription': 'This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled parallel-group study to evaluate the efficacy and safety of cebranopadol in the treatment of postoperative pain following primary unilateral bunionectomy with first metatarsal osteotomy. The study will be conducted in 3 phases: Screening, Treatment, and Follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria Before Surgery:\n\n* Scheduled to undergo primary unilateral bunionectomy with first metatarsal osteotomy and internal fixation with no collateral procedures, using anesthesiologic and surgical procedures planned.\n* Must be able to adhere to the visit schedule, complete all study assessments and protocol requirements, including self-reported questionnaires.\n\nKey Exclusion Criteria Before Surgery:\n\n* Any clinically significant disease, medical condition, or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity, or compromise the safety of the subject.\n* Secondary (i.e., unrelated to bunion) current painful condition that could confound the interpretation of efficacy, safety, or tolerability data in the study, in the opinion of the investigator.\n* Subjects who require any analgesic for secondary (i.e., unrelated to bunion) painful condition that might impact the subject's ability to properly assess their postoperative pain, or that may require treatment during the Treatment Phase.\n* History of allergy or hypersensitivity to any opioid analgesics, anesthetics, ibuprofen, or other NSAIDs.\n\nImmediate Postoperative Exclusion Criteria:\n\n* Surgical, postsurgical, or anesthetic complication that could confound the interpretation of efficacy, safety, or tolerability data in the study.\n* Deviation from the surgical, postsurgical, or anesthetic protocol that could confound the interpretation of efficacy, safety, or tolerability data in the study.\n* Evidence of hemodynamic instability or respiratory insufficiency."}, 'identificationModule': {'nctId': 'NCT06423703', 'acronym': 'ALLEVIATE2', 'briefTitle': 'A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tris Pharma, Inc.'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Primary Unilateral Bunionectomy', 'orgStudyIdInfo': {'id': 'TRN-228-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cebranopadol', 'description': 'once daily for 3 days', 'interventionNames': ['Drug: Cebranopadol', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxycodone IR', 'description': 'four times per day for 3 days', 'interventionNames': ['Drug: Oxycodone IR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'three times per day 3 days (with cebranopadol); four times per day for 3 days (placebo arm)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cebranopadol', 'type': 'DRUG', 'description': 'once daily for 3 days', 'armGroupLabels': ['Cebranopadol']}, {'name': 'Oxycodone IR', 'type': 'DRUG', 'description': 'four times per day for 3 days', 'armGroupLabels': ['Oxycodone IR']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'three times per day 3 days (with cebranopadol), four times per day for 3 days (placebo arm)', 'armGroupLabels': ['Cebranopadol', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35660', 'city': 'Sheffield', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'ALLEVIATE 2 Site 001108', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'ALLEVIATE 2 Site 001106', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'ALLEVIATE 2 Site 001103', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30331', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'ALLEVIATE 2 Site 001102', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'ALLEVIATE 2 Site 001107', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '21122', 'city': 'Pasadena', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'ALLEVIATE 2 Site 001105', 'geoPoint': {'lat': 39.119, 'lon': -76.57108}}, {'zip': '77043', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Alleviate 2 001113', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78501', 'city': 'McAllen', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'ALLEVIATE 2 Site 001104', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'ALLEVIATE 2 Site 001111', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'ALLEVIATE 2 Site 001101', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Liza Micioni', 'role': 'CONTACT', 'email': 'clinicalaffairs@trispharma.com', 'phone': '7326148073'}], 'overallOfficials': [{'name': 'Todd M Bertoch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cenexel JBR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tris Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}