Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-22 @ 4:45 AM
Study NCT ID:
NCT00622518
Status:
COMPLETED
Last Update Posted:
2010-12-02
First Post:
2008-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ear Drops for Children With Otitis Media
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uncjat@u.washington.edu', 'phone': '206-616-1206', 'title': 'James A. Taylor, MD', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'description': 'The main source of adverse event information was from symptom logs. In addition, parents were asked about significant adverse events during phone calls 12-15 days after enrollment.', 'eventGroups': [{'id': 'EG000', 'title': 'Ear Drops Plus Standard Therapy', 'description': 'homeopathic ear drops in addition to standard care for otitis media', 'otherNumAtRisk': 44, 'otherNumAffected': 29, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Therapy Alone', 'description': 'No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen', 'otherNumAtRisk': 50, 'otherNumAffected': 37, 'seriousNumAtRisk': 60, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': '"hyper" behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Resolution of Otitis Media Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ear Drops Plus Standard Therapy', 'description': 'homeopathic ear drops in addition to standard care for otitis media'}, {'id': 'OG001', 'title': 'Standard Therapy Alone', 'description': 'No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen'}], 'classes': [{'title': 'Assessment 1: day 1, am', 'categories': [{'measurements': [{'value': '14.2', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Assessment 2: day 1, pm', 'categories': [{'measurements': [{'value': '7.5', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Assessment 3: day 2, am', 'categories': [{'measurements': [{'value': '6.1', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Assessment 4: day 2, pm', 'categories': [{'measurements': [{'value': '6.7', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Assessment 5: day 3, am', 'categories': [{'measurements': [{'value': '6.1', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Assessment 6: day 3, pm', 'categories': [{'measurements': [{'value': '5.2', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'Assessment 7: day 4, am', 'categories': [{'measurements': [{'value': '3.8', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Assessment 8: day 4, pm', 'categories': [{'measurements': [{'value': '3.3', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Assessment 9: day 5, am', 'categories': [{'measurements': [{'value': '2.8', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '5.7', 'groupId': 'OG001'}]}]}, {'title': 'Assessment 10: day 5, pm', 'categories': [{'measurements': [{'value': '2.3', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.002', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'pValueComment': 'P value is based on rating\\*group interaction term', 'statisticalMethod': 'linear mixed model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were analyzed on participants from whom data diaries were returned and who had data for an assessment. Data were analyzed on the following number of children at each assessment: 1- 50 standard care (SC),40 ear drop (ED) 2- 40SC 35ED 3- 49SC 37ED 4- 40SC 36ED 5- 44SC 35ED 6- 42SC 34ED 7- 44SC 34ED 8- 43SC 31ED 9- 44SC 33ED 10- 44SC 29ED'}, {'type': 'SECONDARY', 'title': 'Side Effects of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ear Drops Plus Standard Therapy', 'description': 'homeopathic ear drops in addition to standard care for otitis media'}, {'id': 'OG001', 'title': 'Standard Therapy Alone', 'description': 'No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen'}], 'classes': [{'title': 'Any side effect reported in diary', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'vomiting reported at least once in diary', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'rash reported at least once in diary', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'diarrhea reported at least once in diary', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': '"hyper" behavior reported at least once in diary', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'headache reported at least once in diary', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'lethargy reported at least once in diary', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'other symptom reported at least once in diary', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'serious side effect reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '5 days', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Specific side effects were collected on patients whose parents returned study diaries (44 from ear drop group and 50 from standard care only group). In addition, parents were telephoned and asked about any serious side effects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ear Drops Plus Standard Therapy', 'description': 'homeopathic ear drops in addition to standard care for otitis media'}, {'id': 'FG001', 'title': 'Standard Therapy Alone', 'description': 'No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'patients were recruited from 2/4/08 through 2/23/09 at a pediatric primary care clinic at the time of a visit for acute otitis media'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ear Drops Plus Standard Therapy', 'description': 'homeopathic ear drops in addition to standard care for otitis media'}, {'id': 'BG001', 'title': 'Standard Therapy Alone', 'description': 'No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '2.4', 'groupId': 'BG001'}, {'value': '3.5', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-04', 'studyFirstSubmitDate': '2008-02-13', 'resultsFirstSubmitDate': '2010-09-28', 'studyFirstSubmitQcDate': '2008-02-22', 'lastUpdatePostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-11-04', 'studyFirstPostDateStruct': {'date': '2008-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of Otitis Media Symptoms', 'timeFrame': '5 days', 'description': 'Mean scores as measured on the Ear Treatment Group-5 scale. This scale quantifies severity of symptoms in children with otitis media. There are 5 components to the scale: fever, earache or tugging, feeding, irritability and sleep. For each component symptoms are rated as 0, 4 or 7 based on severity, with higher scores indicating more sever symptoms. For the primary outcome, the scores for each component were summed to determine an overall Ear Treatment Group -5 Scale score. Total scores range from 0-35. Two assessessments were conducted each day.'}], 'secondaryOutcomes': [{'measure': 'Side Effects of Therapy', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['otitis media', 'children'], 'conditions': ['Acute Otitis Media']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media. A total of 120 study patients with otitis media will be randomized to receive homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is postulated that children using the ear drops will have more rapid resolution of symptoms and need fewer antibiotics than those randomized to not receive the ear drops.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presenting to participating clinic with otitis media\n* Diagnosed with acute otitis media\n* Parents rate symptoms as a "moderate problem" or more\n\nExclusion Criteria:\n\n* Diagnosis of otitis media within preceding 30 days\n* Receipt of antibiotics within 2 days\n* Perforated ear drum or bullous lesion\n* Receipt of homeopathic treatment within 30 days'}, 'identificationModule': {'nctId': 'NCT00622518', 'briefTitle': 'Ear Drops for Children With Otitis Media', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Ear Drops for Children With Otitis Media', 'orgStudyIdInfo': {'id': '33097-B'}, 'secondaryIdInfos': [{'id': '07-9092-B 01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'homeopathic ear drops in addition to standard care for otitis media', 'interventionNames': ["Drug: Hyland's earache drops"]}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'No ear drops, standard care for otitis'}], 'interventions': [{'name': "Hyland's earache drops", 'type': 'DRUG', 'description': '3-4 drops in affected ear 3 times a day as needed for up to 5 days', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center-Roosevelt Pediatric Care Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'James A Taylor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Standard Homeopathic Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'James A. Taylor, MD, Professor', 'oldOrganization': 'University of Washington'}}}}