Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT05962151
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2023-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Refractory Chronic Cough Improvement Via NAL ER (RIVER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096822', 'term': 'Chronic Cough'}, {'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009266', 'term': 'Nalbuphine'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2023-07-07', 'studyFirstSubmitQcDate': '2023-07-18', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Change From Baseline in 24-hour Cough Frequency at Day 21', 'timeFrame': 'Baseline, Day 21'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Week 15'}, {'measure': 'Relative Change From Baseline in 24-hour Cough Frequency at Days 7 and 14', 'timeFrame': 'Baseline, Day 7 and 14'}, {'measure': 'Percentage of Participants With >=30%, 50% and 75% Reduction in 24-hour Cough Frequency at Days 7, 14, and 21', 'timeFrame': 'At Days 7, 14, and 21'}, {'measure': 'Relative Change From Baseline in Awake Cough Frequency at Days 7, 14, and 21', 'timeFrame': 'Baseline, Day 7, 14 and 21'}, {'measure': 'Relative Change From Baseline in Sleep Cough Frequency at Days 7, 14, and 21', 'timeFrame': 'Baseline, Day 7, 14 and 21'}, {'measure': 'Change From Baseline in Cough Severity Visual Analogue Scale at Days 7, 14, and 21', 'timeFrame': 'Baseline, Day 7, 14 and 21'}, {'measure': 'Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score at Day 21', 'timeFrame': 'Baseline, Day 21'}, {'measure': 'Change From Baseline in Patient-Reported Cough Frequency (PR-CF) at Days 7, 14, and 21', 'timeFrame': 'Baseline, Day 7, 14 and 21'}, {'measure': 'Percentage of PR-CF Responders With at Least one Category Improvement at Days 7, 14, and 21', 'timeFrame': 'At Days 7, 14, and 21'}, {'measure': 'Change From Baseline in Patient Global Impression of Severity (PGI-S) Cough at Days 7, 14, and 21', 'timeFrame': 'Baseline, Day 7, 14 and 21'}, {'measure': 'Absolute Values of Patient Global Impression of Change for Cough (PGI-C) Score at Days 7, 14, and 21', 'timeFrame': 'At Days 7, 14, and 21'}, {'measure': 'Change From Baseline in Clinicians Global Impression of Cough Severity Score at Day 21', 'timeFrame': 'Baseline, Day 21'}, {'measure': 'Absolute Values of Clinicians Global Impression of Change for Cough Score at Day 21', 'timeFrame': 'At Day 21'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['RCC', 'Cough', 'Nalbuphine'], 'conditions': ['Refractory Chronic Cough']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to evaluate the effect of NAL ER on 24-hour cough frequency and to assess safety and tolerability of NAL-ER for treatment of refractory chronic cough.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Diagnosis of refractory chronic cough (RCC) for at least one year\n* Chest radiograph or CT of thorax within 24 months or during screening not demonstrating any significant abnormalities contributing to RCC\n\nExclusion Criteria:\n\n* Diagnosis of sleep apnea\n* Respiratory tract infection within 6 weeks of Baseline\n* History of bronchiectasis, COPD, or IPF\n* History of uncontrolled asthma\n* Current smokers/vapers, quit smoking with \\<=12 months, using nicotine supplements, or history of \\>=20 pack years\n* History of major psychiatric disorder\n* History of substance abuse\n* Pregnant or lactating females\n* Known intolerance to opioids\n* Abnormal kidney or liver functions based on Screening lab results.\n* Known hypersensitivity to nalbuphine or to NAL ER excipients\n* Previous participation in a nalbuphine ER clinical study\n* Use of opiates, benzodiazepines, or MAOIs within 14 days of Baseline\n* Use of pregabalin, gabapentin, thalidomide for treatment of cough within 14 days of Baseline\n* Use of ACE inhibitors within 12 weeks of Baseline\n* Use of a medication having a "known risk" of Torsade de Pointes (categorized as "KR" on the Credible Meds® website.) 4 weeks prior to Baseline\n* Use of unstable doses of medications associated with a potential risk of QT prolongation but not clearly associated with Torsade de Pointes within 4 weeks of screening.\n* Use of unstable doses of cough suppressants within 14 days of Baseline\n* Use of unstable doses of medications that affect serotonergic neurotransmission that may cause serotonin syndrome with opioids within14 days of Baseline\n* Use of unstable doses of P450 isozyme inhibitors/inducers within 14 days of Baseline\n\nOther protocol defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05962151', 'acronym': 'RIVER', 'briefTitle': 'Refractory Chronic Cough Improvement Via NAL ER (RIVER)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Trevi Therapeutics'}, 'officialTitle': 'A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Two-Period Crossover Efficacy and Safety Study of Nalbuphine ER Tablets for the Treatment of Refractory Chronic Cough', 'orgStudyIdInfo': {'id': 'NAL04-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'First NAL ER, then Placebo', 'description': 'Participants will receive NAL ER at escalating doses (27 mg QD to BID, 54 mg BID, and 108 mg BID) in Treatment Period 1, followed by placebo matched to NAL ER in Treatment Period 2.', 'interventionNames': ['Drug: NAL ER', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'First Placebo then NAL ER', 'description': 'Participants will receive placebo matched to NAL ER in Treatment Period 1, followed by NAL ER at escalating doses (27 mg QD to BID, 54 mg BID, and 108 mg BID) in Treatment Period 2.', 'interventionNames': ['Drug: NAL ER', 'Drug: Placebo']}], 'interventions': [{'name': 'NAL ER', 'type': 'DRUG', 'otherNames': ['Nalbuphine'], 'description': 'Oral tablets', 'armGroupLabels': ['First NAL ER, then Placebo', 'First Placebo then NAL ER']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral tablets', 'armGroupLabels': ['First NAL ER, then Placebo', 'First Placebo then NAL ER']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster University Medical Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5T 3A9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Inspiration Research', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G8T 7A1', 'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CIC Mauricie Inc.', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}, {'zip': 'HU16 5JQ', 'city': 'Cottingham', 'state': 'East Riding Of Yorkshire', 'country': 'United Kingdom', 'facility': 'Hull and East Yorkshire Hospitals NHS Trust - Castle Hill Hospital', 'geoPoint': {'lat': 52.50243, 'lon': -0.7554}}, {'zip': 'SE5 9RS', 'city': 'London', 'state': 'Greater London', 'country': 'United Kingdom', 'facility': 'Kings College Hospital NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M23 9LT', 'city': 'Manchester', 'state': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'University Hospital of South Manchester NHS Foundation Trust (UHSM) - Wythenshawe Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'BR5 3QG', 'city': 'Orpington', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'Accellacare South London', 'geoPoint': {'lat': 51.37457, 'lon': 0.09785}}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Accellacare North London', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'BT9 7AB', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'NE29 8NH', 'city': 'North Shields', 'state': 'Tynemouth', 'country': 'United Kingdom', 'facility': 'North Tyneside General Hospital - Northumbria Healthcare NHS Foundation Trust', 'geoPoint': {'lat': 55.01646, 'lon': -1.44925}}, {'zip': 'CV3 4FJ', 'city': 'Coventry', 'state': 'Warwickshire', 'country': 'United Kingdom', 'facility': 'Accellacare Warwickshire', 'geoPoint': {'lat': 52.40656, 'lon': -1.51217}}, {'zip': 'B15 2GW', 'city': 'Birmingham', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'University Hospitals Birmingham NHS Foundation Trust', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BD18 3SA', 'city': 'Shipley', 'state': 'Yorkshire', 'country': 'United Kingdom', 'facility': 'Accellacare Yorkshire', 'geoPoint': {'lat': 53.83333, 'lon': -1.76667}}, {'zip': 'HP11 2QW', 'city': 'High Wycombe', 'country': 'United Kingdom', 'facility': 'Egin Research Ltd', 'geoPoint': {'lat': 51.62907, 'lon': -0.74934}}], 'overallOfficials': [{'name': 'Chief Development Officer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Trevi Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trevi Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}