Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT01988558
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2013-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014069', 'term': 'Tonsillitis'}], 'ancestors': [{'id': 'D010612', 'term': 'Pharyngitis'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019344', 'term': 'Lactic Acid'}], 'ancestors': [{'id': 'D007773', 'term': 'Lactates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-06', 'studyFirstSubmitDate': '2013-11-03', 'studyFirstSubmitQcDate': '2013-11-11', 'lastUpdatePostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'QOL Questionnaire', 'timeFrame': 'Chnge from baseline at 90 days post treatment'}], 'primaryOutcomes': [{'measure': 'Safety evaluation - Number of participants with adverse events', 'timeFrame': 'At 90 days post treatment'}], 'secondaryOutcomes': [{'measure': 'Tonsil Size', 'timeFrame': 'Chnge from baseline at 6 months post treatment'}, {'measure': 'Number of Tonsillitis episodes', 'timeFrame': 'Chnge in medical history number of recurrent Tonsillitis episodes within 6 months post treatment'}]}, 'conditionsModule': {'keywords': ['Recurrent Tonsillitis', 'Streptococcus A'], 'conditions': ['Recurrent Tonsillitis in Children']}, 'descriptionModule': {'briefSummary': 'The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children at the ages of 5-16.\n* Patient is suffering from recurrent documented sore throat with at least 4 tonsillitis episodes during the preceding year (at least one verified by culture or rapid antigen testing for Streptococcus A).\n* Patient with clinical presentation of irregular tonsils.\n* Tonsils size graded between 2.5-4.\n* Clinical diagnosis of bacterial known in recurrent pharyngeal-tonsillitis.\n* Patient is willing to participate in the study and adhere to the study protocol\n* Patient's guardian and/or Patient have signed informed consent.\n\nExclusion Criteria:\n\n* Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes (Positive RSAT or microbial culture).\n* Subjects who are known as Streptococcus pyogenes carriers\n* Subject's requiring any other medication (topical or systemic) that may affect the course of the disease during the study period (e.g. antibiotics, sedating antihistamines), and/or did not completed 14 days from end of antibiotics treatment.\n* Subjects with known hypersensitivity to lactose.\n* Subject is suffering from peritonsillar abscess.\n* Subject suffers from an active peptic ulcer\n* Subjects who are suffering from any concomitant disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study results.\n* Subject is currently participating in another clinical study."}, 'identificationModule': {'nctId': 'NCT01988558', 'briefTitle': 'A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yali Pharmaceuticals'}, 'officialTitle': 'A Phase I/II, Randomized, Double Blind, Placebo-controlled Study to Assess the Safety, Tolerability and Efficacy of DL-lactic Acid Syrup (Tonsitin) in Children With Recurrent Tonsillitis.', 'orgStudyIdInfo': {'id': 'LA-001-IL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated Group', 'description': 'Children diagnosed as suffering from recurrent Tonsillitis (at least 4 episodes per year) to receive DL-Lactic acid syrup twice a day for a month.', 'interventionNames': ['Drug: DL - Lactic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'interventionNames': ['Dietary Supplement: Raspberry flavored syrup']}], 'interventions': [{'name': 'DL - Lactic Acid', 'type': 'DRUG', 'description': 'Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)', 'armGroupLabels': ['Treated Group']}, {'name': 'Raspberry flavored syrup', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo group to receive Raspberry flavored Syrup', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'state': 'Israel', 'country': 'Israel', 'facility': 'Clalit Health Services, Pediatric Community Ambulatory Clinic', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Petah Tikva', 'state': 'Israel', 'country': 'Israel', 'facility': 'Clalit Health Services, Pediatric Community Ambulatory Ganei Hadar clinic', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Tzrifin', 'country': 'Israel', 'facility': 'Assaf Harofeh Medical Center', 'geoPoint': {'lat': 31.95649, 'lon': 34.84002}}], 'overallOfficials': [{'name': 'Mati Berkovitz, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yali Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}