Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT04162795
Status:
COMPLETED
Last Update Posted:
2021-02-04
First Post:
2019-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies
Sponsor:
Organization:
Raw JSON
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Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Kaplan-Meier Estimates of the duration of the cooling sensation were not able to be reported in this data set.'}}, 'adverseEventsModule': {'timeFrame': 'From the signing of the informed consent form (ICF) until discharge from the study site (1 day)', 'eventGroups': [{'id': 'EG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.', 'otherNumAtRisk': 442, 'deathsNumAtRisk': 442, 'otherNumAffected': 9, 'seriousNumAtRisk': 442, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Laryngeal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Salivary duct inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Ocular sensory symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 442, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Participants With Agreement of Perception of Cooling Sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the product provides a cooling sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'classes': [{'title': 'Cooling in Mouth', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.98', 'upperLimit': '1.00'}]}]}, {'title': 'Cooling in Nose', 'categories': [{'measurements': [{'value': '0.71', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '0.76'}]}]}, {'title': 'Cooling in Throat', 'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.90', 'upperLimit': '0.95'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to respond to question "the product provides a cooling sensation in the mouth, nose or throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement of Perception of Refreshing Sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'classes': [{'title': 'Refreshing', 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '0.98'}]}]}, {'title': '...Refreshing in Mouth', 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '0.97'}]}]}, {'title': '...Refreshing in Nose', 'categories': [{'measurements': [{'value': '0.61', 'groupId': 'OG000', 'lowerLimit': '0.57', 'upperLimit': '0.66'}]}]}, {'title': '...Refreshing in Throat', 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '0.91'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the product provides a refreshing sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.94', 'upperLimit': '0.97'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the cooling sensation is refreshing" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the refreshing of the cooling sensation.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '0.96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the sensory experience is unique for an allergy medicine" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the unique sensory experience sensation.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement of Soothing Feeling on the Throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.86', 'upperLimit': '0.92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the product feels soothing on the throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the soothing feeling.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '0.90'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "I like the flavor sensation of the product" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of liking the enjoyable flavor sensation.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement of the Enjoyable Product Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.85', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '0.88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the product experience was enjoyable" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the enjoyable experience.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With Agreement of the Great Taste of the Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.73', 'upperLimit': '0.81'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the product tastes great" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the great taste.', 'unitOfMeasure': 'Proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}, {'type': 'SECONDARY', 'title': 'Time to Perception of Cooling Sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'classes': [{'title': 'Cooling in Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '437', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.82', 'groupId': 'OG000', 'lowerLimit': '5.33', 'upperLimit': '6.32'}]}]}, {'title': 'Cooling in Nose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '320', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.97', 'groupId': 'OG000', 'lowerLimit': '13.00', 'upperLimit': '16.94'}]}]}, {'title': 'Cooling in Throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '410', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.17', 'groupId': 'OG000', 'lowerLimit': '14.43', 'upperLimit': '17.91'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 60 minutes post ingestion of study medication', 'description': 'The mean time point at which cooling was initially perceived was claimed as the onset of cooling. The mean onsets of cooling sensation in the mouth, nose and throat were reported.', 'unitOfMeasure': 'Seconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}, {'type': 'SECONDARY', 'title': 'Duration of Cooling Sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'classes': [{'title': 'Cooling in Mouth', 'categories': [{'measurements': [{'value': '20', 'comment': 'The analysis of duration of cooling sensation was based on a Kaplan-Meier survival model. The Kaplan-Meier figures are included in the study report but cannot be provided in this data set. The specific dispersion values are not included in the study report or source tables for this sensory study.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Cooling in Nose', 'categories': [{'measurements': [{'value': '20', 'comment': 'The analysis of duration of cooling sensation was based on a Kaplan-Meier survival model. The Kaplan-Meier figures are included in the study report but cannot be provided in this data set. The specific dispersion values are not included in the study report or source tables for this sensory study.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Cooling in the Throat', 'categories': [{'measurements': [{'value': '15', 'comment': 'The analysis of duration of cooling sensation was based on a Kaplan-Meier survival model. The Kaplan-Meier figures are included in the study report but cannot be provided in this data set. The specific dispersion values are not included in the study report or source tables for this sensory study.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 60 minutes post ingestion of study medication', 'description': 'Participants who reported that they never experienced a cooling sensation were not included in the model. Those for whom the cooling sensation extended for 60 minutes or more were considered right-censored and were treated as such in the model. The median time of cooling sensation in the mouth, nose and throat was reported. Dispersion values were not calculated for this sensory study.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '468'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '442'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Screen failures', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}], 'recruitmentDetails': 'Study was conducted at multiple centers in the US between 12 November 2019 (first participant first visit) and 13 November 2019 (last participant last visit).', 'preAssignmentDetails': 'Overall, 468 participants were screened. Of them, 10 participants were screen failures and 16 participants did not complete the study with early termination. 442 participants received study treatment and completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Loratadine Chewable Tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18- 34 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': '35- 44 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': '45- 54 years', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}]}]}, {'title': '55+ years', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Percentage of participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Percentage of participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Other races', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Percentage of participants'}], 'populationDescription': 'All participants who received the study medication and had an evaluation data for study medication'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-21', 'size': 816059, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-28T22:10', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Participants were blinded to product brand'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 468}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-15', 'studyFirstSubmitDate': '2019-11-12', 'resultsFirstSubmitDate': '2020-10-29', 'studyFirstSubmitQcDate': '2019-11-12', 'lastUpdatePostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-15', 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Participants With Agreement of Perception of Cooling Sensation', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the product provides a cooling sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to respond to question "the product provides a cooling sensation in the mouth, nose or throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.'}, {'measure': 'Proportion of Participants With Agreement of Perception of Refreshing Sensation', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the product provides a refreshing sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.'}, {'measure': 'Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the cooling sensation is refreshing" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the refreshing of the cooling sensation.'}, {'measure': 'Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the sensory experience is unique for an allergy medicine" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the unique sensory experience sensation.'}, {'measure': 'Proportion of Participants With Agreement of Soothing Feeling on the Throat', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the product feels soothing on the throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the soothing feeling.'}, {'measure': 'Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "I like the flavor sensation of the product" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of liking the enjoyable flavor sensation.'}, {'measure': 'Proportion of Participants With Agreement of the Enjoyable Product Experience', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the product experience was enjoyable" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the enjoyable experience.'}, {'measure': 'Proportion of Participants With Agreement of the Great Taste of the Product', 'timeFrame': 'Up to 5 minutes post ingestion of study medication', 'description': 'Participants were asked to response to question "the product tastes great" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the great taste.'}, {'measure': 'Time to Perception of Cooling Sensation', 'timeFrame': 'Up to 60 minutes post ingestion of study medication', 'description': 'The mean time point at which cooling was initially perceived was claimed as the onset of cooling. The mean onsets of cooling sensation in the mouth, nose and throat were reported.'}, {'measure': 'Duration of Cooling Sensation', 'timeFrame': 'Up to 60 minutes post ingestion of study medication', 'description': 'Participants who reported that they never experienced a cooling sensation were not included in the model. Those for whom the cooling sensation extended for 60 minutes or more were considered right-censored and were treated as such in the model. The median time of cooling sensation in the mouth, nose and throat was reported. Dispersion values were not calculated for this sensory study.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allergy', 'Upper respiratory allergies'], 'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'In this study, researchers were primarily interested in evaluating the level of agreement of cooling sensation provided by this chewable, flavored, allergy medicine. Participants joining this study received one test drug tablet and were asked to chew completely before swallowing the drug. A questionnaire was used to collect the feedback from participants. The study involved only one (1) visit and participant stayed in this study for about 60-75 minutes to evaluate the cooling sensation as well as other sensory attributes perceived in the mouth, nose and throat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male adults aged 18 to 65 years of age inclusive\n* Were in good general health\n* Previous self-reported sufferers of upper respiratory allergies who at the time of the study are either asymptomatic, symptomatic but not treating and agree to use study medication or symptomatic and treating with an allergy medicine that is not an antihistamine\n* Agreed to not use antihistamine products 24 hours before and after the treatment\n* Willing to avoid eating food or candy (other than crackers consumed during testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to testing\n\nExclusion Criteria:\n\n* Individuals who had used oral/systemic medications 24 hours before the first administration of test product\n* Individuals who used medications which might influence taste perception\n* Individuals who had received or used an investigational new drug in the last 30 days or had been an active participant in another clinical or market research study in the last 30 days\n* Women who were pregnant or thinking of becoming pregnant or were nursing\n* Participants with congestion at the time of study visit\n* Any self-reported symptoms or conditions that might interfere with the participants ability to complete the evaluation of the product on testing day\n* Any current medical condition that in the opinion of the Investigator or designee might interfere with normal taste and/or temperature perception (e.g., active common cold, sinus infection, bronchial infection, adenoids, paresthesia etc.)\n* History of alcohol or drug abuse\n* History of hypersensitivity or allergic reactions to any ingredients in the test product\n* Individuals with a history of glaucoma, liver or kidney disease, respiratory conditions such as chronic bronchitis or swallowing difficulties\n* Individuals who were currently wearing any kind of dental braces or with dental work or had cavities and associated pain that might affect their ability to chew a tablet'}, 'identificationModule': {'nctId': 'NCT04162795', 'briefTitle': 'A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open Label, Multi-center Study to Evaluate Sensory Attributes of an Antihistamine Product', 'orgStudyIdInfo': {'id': '21048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Loratadine chewable tablet', 'description': 'Participants received one dose of loratadine chewable tablet to chew completely before swallowing.', 'interventionNames': ['Drug: Loratadine (Claritin, BAY76-2211)']}], 'interventions': [{'name': 'Loratadine (Claritin, BAY76-2211)', 'type': 'DRUG', 'description': 'Chewable tablet, oral, single dose', 'armGroupLabels': ['Loratadine chewable tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Focus Pointe Global', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Availability of this study\'s data will be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}