Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT01948856
Status:
COMPLETED
Last Update Posted:
2017-02-03
First Post:
2013-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D003139', 'term': 'Common Cold'}, {'id': 'D007827', 'term': 'Laryngitis'}, {'id': 'D010612', 'term': 'Pharyngitis'}, {'id': 'D014069', 'term': 'Tonsillitis'}, {'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}]}}, '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': 'ACTUAL', 'count': 1003}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2013-09-19', 'studyFirstSubmitQcDate': '2013-09-23', 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Upper-Respiratory Tract Infections (URTI) episodes medically assessed over year 2', 'timeFrame': 'at each infectious episode over year 2', 'description': 'Each URTI episodes will be medically assessed by the investigator by a thorough medical examination.'}]}, 'conditionsModule': {'keywords': ['Recurrent common cold', 'laryngitis', 'pharyngitis/tonsillitis', 'acute rhinitis', 'acute rhinosinusitis', 'acute otitis media'], 'conditions': ['Recurrent Upper-Respiratory Tract Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of J022X ST for prevention of Recurrent Upper-Respiratory Tract Infections (RURTI) compared to placebo in children of younger age who develop infectious diseases more frequently than other children of this age in general.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\nPatients with all the following criteria will be eligible for inclusion in Year 1:\n\n* Children, male or female\n* Aged 3 to 4 years\n* Children known for recurrent URTIs in the past year (based on medical recording or reported history)\n* Children at risk for URTI in the physician's opinion (e.g. absence of breastfeeding, hospitalization in the previous year, tonsillectomy or adenoidectomy, parental smoking, daycare institution or nursery school, early schooling, prematurity, low weight at birth, malnutrition, failure to thrive).\n\nPatients with all the following criteria will be eligible for randomisation in Year 2:\n\n* Children, male or female\n* Aged 4 to 5 years\n* Suffering from RURTI, i.e. at least 6 URTI episodes medically confirmed, with a maximum of 18, during the Year 1 of the study.\n\nKey Exclusion Criteria:\n\nPresence of diseases (Chronic suppurative otitis media, acute broncho-pulmonary infection, Immune deficiency or disorders, surgery of respiratory tract, cystic fibrosis…) or treatments (chronic use of corticosteroids, bronchodilators, ...) that may impact the safety, the interpretation of the results and/or the participation of the subject in the study"}, 'identificationModule': {'nctId': 'NCT01948856', 'briefTitle': 'CLEARI (Clinical Efficacy Assessment on Recurrent Upper-Respiratory Tract Infections) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pierre Fabre Medicament'}, 'orgStudyIdInfo': {'id': 'J0022X ST 3 02'}, 'secondaryIdInfos': [{'id': '2013-001760-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'J022X ST', 'interventionNames': ['Drug: J022X ST']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'J022X ST', 'type': 'DRUG', 'description': 'Oral administration - During 6 months and according to the approved summary of product characteristics : 1 sachet per day in the morning on an empty stomach\n\n* First month: 4 consecutive days per week during 3 consecutive weeks\n* 5 next months: 4 consecutive days per month at monthly intervals', 'armGroupLabels': ['J022X ST']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral administration - During 6 months : 1 sachet per day in the morning on an empty stomach\n\n* First month: 4 consecutive days per week during 3 consecutive weeks\n* 5 next months: 4 consecutive days per month at monthly intervals', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ancona', 'country': 'Italy', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'L’Aquila', 'country': 'Italy', 'geoPoint': {'lat': 42.35055, 'lon': 13.39954}}, {'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Modena', 'country': 'Italy', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Napoli', 'country': 'Italy', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Roma', 'country': 'Italy', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Varese', 'country': 'Italy', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'city': 'Kaunas', 'country': 'Lithuania', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Panevezys', 'country': 'Lithuania', 'geoPoint': {'lat': 55.73186, 'lon': 24.35983}}, {'city': 'Vilnius', 'country': 'Lithuania', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': 'Lesznowola', 'country': 'Poland', 'geoPoint': {'lat': 52.09095, 'lon': 20.93479}}, {'city': 'Lublin', 'country': 'Poland', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Ostrołęka', 'country': 'Poland', 'geoPoint': {'lat': 53.08621, 'lon': 21.57566}}, {'city': 'Warsaw', 'country': 'Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'city': 'Węgrów', 'country': 'Poland', 'geoPoint': {'lat': 52.39954, 'lon': 22.01634}}, {'city': 'Wołomin', 'country': 'Poland', 'geoPoint': {'lat': 52.34006, 'lon': 21.24207}}, {'city': 'Bacau', 'country': 'Romania', 'geoPoint': {'lat': 46.56718, 'lon': 26.91384}}, {'city': 'Brasov', 'country': 'Romania', 'geoPoint': {'lat': 45.64861, 'lon': 25.60613}}, {'city': 'Bucharest', 'country': 'Romania', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Constanța', 'country': 'Romania', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'city': 'Craiova', 'country': 'Romania', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'city': 'Sibiu', 'country': 'Romania', 'geoPoint': {'lat': 45.8, 'lon': 24.15}}, {'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Saint Petersburg', 'country': 'Russia', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}], 'overallOfficials': [{'name': 'Karim KEDDAD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pierre Fabre Medicament'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pierre Fabre Medicament', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}