Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT03583658
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2018-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010612', 'term': 'Pharyngitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2018-09-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2018-06-28', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in pain intensity difference (PID)', 'timeFrame': 'hour 3', 'description': 'Change from baseline to hour 3 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-3h)'}], 'secondaryOutcomes': [{'measure': 'Change in SPID', 'timeFrame': 'hour 24', 'description': 'Change from baseline to hour 24 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-24h)'}, {'measure': '3-hour patient assessment of efficacy', 'timeFrame': 'hour 3', 'description': 'Patient assessment of efficacy after 3 hours of the first study drug intake using a 5-point verbal rating scale (VRS) to rate whether the trial medication relieves sore throat pain, where 0 = poor and 4 = excellent'}, {'measure': '24-hour patient assessment of efficacy', 'timeFrame': 'hour 24', 'description': 'Patient assessment of efficacy after 24 hours of the first study drug intake using a 5-point VRS'}, {'measure': 'Adverse events', 'timeFrame': 'baseline to day 4', 'description': 'Incidence of the adverse events'}, {'measure': 'Patient assessment of tolerability', 'timeFrame': 'hour 3, hour 24 and day 2, day 3 or day 4', 'description': 'Patient assessment of tolerability after 3 hours, Day 1, on Day 2, Day 3 and Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent'}, {'measure': 'Final assessment of tolerability', 'timeFrame': 'day 4', 'description': 'Investigator and patient assessment of tolerability on Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharyngitis']}, 'referencesModule': {'references': [{'pmid': '32026411', 'type': 'DERIVED', 'citation': 'Sousa R, Lakha DR, Brette S, Hitier S. A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis. Pulm Ther. 2019 Dec;5(2):201-211. doi: 10.1007/s41030-019-00100-w. Epub 2019 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo assess the efficacy of the new hard boiled Ambroxol lozenges 20 mg for the relief of sore throat pain in patients with acute pharyngitis.\n\nSecondary Objective:\n\nTo assess the safety of the new hard boiled Ambroxol lozenges 20 mg in patients with acute pharyngitis.', 'detailedDescription': 'Duration per participant is up to 4 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Adult male or female patients complaining of sore throat due to acute pharyngitis with an onset no more than 72 hours prior to Visit 1.\n* Patients with a score of 6 or greater on a 0-10-point pain intensity numerical rating scale.\n* Signed written informed consent.\n\nExclusion criteria:\n\nPatients suffering from pharyngitis of bacterial origin.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT03583658', 'acronym': 'DELICIOUS', 'briefTitle': 'Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial to Assess the Efficacy and Safety of Ambroxol Lozenges 20 mg (Hard Boiled Lozenges) Versus Placebo for the Relief of Sore Throat Pain in Patients With Acute Pharyngitis', 'orgStudyIdInfo': {'id': 'LPS15328'}, 'secondaryIdInfos': [{'id': 'U1111-1202-9392', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ambroxol hydrochloride (BIH1526)', 'description': 'One lozenge 20 mg on as-needed basis, up to 6 times per day', 'interventionNames': ['Drug: ambroxol BIH1526']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'One lozenge on as-needed basis, up to 6 times per day', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'ambroxol BIH1526', 'type': 'DRUG', 'description': 'Pharmaceutical form: lozenges Route of administration: oromucosal', 'armGroupLabels': ['Ambroxol hydrochloride (BIH1526)']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Pharmaceutical form: lozenges Route of administration: oromucosal', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Investigational Site Number 7100005', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}