Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-25 @ 3:28 PM
Study NCT ID:
NCT01700192
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2012-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Corporate Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 54 weeks', 'description': 'The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).', 'eventGroups': [{'id': 'EG000', 'title': 'MK-8237 12 DU', 'description': 'Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.', 'otherNumAtRisk': 743, 'otherNumAffected': 642, 'seriousNumAtRisk': 743, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.', 'otherNumAtRisk': 738, 'otherNumAffected': 389, 'seriousNumAtRisk': 738, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1637, 'numAffected': 382}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 244, 'numAffected': 92}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 212, 'numAffected': 92}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 87, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 85, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 42, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 296, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 58, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 353, 'numAffected': 140}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 42, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Mouth swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 165, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 32, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 196, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 41, 'numAffected': 27}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 293, 'numAffected': 121}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 111, 'numAffected': 57}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oral pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1966, 'numAffected': 468}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 277, 'numAffected': 109}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Palatal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 183, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 173, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 28, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Swollen tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 255, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 31, 'numAffected': 17}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tongue ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 232, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 29, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 81, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 68, 'numAffected': 61}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 76, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 87, 'numAffected': 74}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 143, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 48, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 43, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 63, 'numAffected': 47}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pharyngeal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 268, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 40, 'numAffected': 23}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 2144, 'numAffected': 506}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 505, 'numAffected': 172}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oral pain', 'notes': 'Due to overdose; classified as SAE by sponsor but does not meet International Council for Harmonisation (ICH) SAE criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Oral pruritus', 'notes': 'Due to overdose; classified as SAE by sponsor but does not meet ICH SAE criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Infected bites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hepatic cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Calculus ureteric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Throat irritation', 'notes': 'Due to overdose; classified as SAE by sponsor but does not meet ICH SAE criteria.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 743, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 738, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v. 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '620', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8237', 'description': 'Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.67', 'spread': '3.55', 'groupId': 'OG000'}, {'value': '5.49', 'spread': '3.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.80', 'ciLowerLimit': '-1.20', 'ciUpperLimit': '-0.40', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference Relative to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.2', 'ciLowerLimit': '-25.0', 'ciUpperLimit': '-9.7', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Last 8 weeks of treatment (Weeks 44 to 52)', 'description': 'The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Experience At Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '743', 'groupId': 'OG000'}, {'value': '738', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8237', 'description': 'Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.'}], 'classes': [{'categories': [{'measurements': [{'value': '676', 'groupId': 'OG000'}, {'value': '539', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 54 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The All Participants as Treated (APaT) population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinue Study Drug Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '743', 'groupId': 'OG000'}, {'value': '738', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8237', 'description': 'Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).'}, {'type': 'SECONDARY', 'title': 'Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '620', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8237', 'description': 'Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.83', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '4.46', 'spread': '2.80', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '-0.30', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference Relative to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.5', 'ciLowerLimit': '-24.4', 'ciUpperLimit': '-7.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Last 8 weeks of treatment (Weeks 44 to 52)', 'description': 'The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.'}, {'type': 'SECONDARY', 'title': 'Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '620', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8237', 'description': 'Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.84', 'spread': '1.817', 'groupId': 'OG000'}, {'value': '1.03', 'spread': '2.074', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.154', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.05', 'statisticalMethod': 'Zero-inflated Log-normal Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference Relative to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.4', 'ciLowerLimit': '-41', 'ciUpperLimit': '4.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Last 8 weeks of treatment (Weeks 44 to 52)', 'description': 'The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.'}, {'type': 'SECONDARY', 'title': 'Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '620', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8237', 'description': 'Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.40', 'spread': '5.16', 'groupId': 'OG000'}, {'value': '7.62', 'spread': '5.48', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.10', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '-0.60', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference Relative to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.7', 'ciLowerLimit': '-24.6', 'ciUpperLimit': '-4.0', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Last 8 weeks of treatment (Weeks 44 to 52)', 'description': 'The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.'}, {'type': 'SECONDARY', 'title': 'Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '540', 'groupId': 'OG000'}, {'value': '585', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-8237', 'description': 'Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.29', 'spread': '23.57', 'groupId': 'OG000'}, {'value': '47.96', 'spread': '23.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.10', 'ciLowerLimit': '-9.10', 'ciUpperLimit': '-3.10', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference Relative to Placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.0', 'ciLowerLimit': '-22.7', 'ciUpperLimit': '-8.3', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Last 8 weeks of treatment (Weeks 44 to 52)', 'description': 'Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-8237', 'description': 'Participants took MK-8237 12 development unit (DU) rapidly dissolving tablets administered sublingually once daily (q.d.) for up to one year.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '741'}, {'groupId': 'FG001', 'numSubjects': '741'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '740'}, {'groupId': 'FG001', 'numSubjects': '741'}]}, {'type': 'All Participants as Treated (APaT)', 'achievements': [{'comment': 'Three participants randomized to receive placebo were given MK-8237 12 DU.', 'groupId': 'FG000', 'numSubjects': '743'}, {'comment': 'Three participants randomized to receive placebo were given MK-8237 12 DU.', 'groupId': 'FG001', 'numSubjects': '738'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '561'}, {'groupId': 'FG001', 'numSubjects': '613'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '128'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Noncompliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'Never received study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '741', 'groupId': 'BG000'}, {'value': '741', 'groupId': 'BG001'}, {'value': '1482', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MK-8237', 'description': 'Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34.9', 'spread': '13.82', 'groupId': 'BG000', 'lowerLimit': '12', 'upperLimit': '77'}, {'value': '35.2', 'spread': '13.74', 'groupId': 'BG001', 'lowerLimit': '12', 'upperLimit': '85'}, {'value': '35.1', 'spread': '13.77', 'groupId': 'BG002', 'lowerLimit': '12', 'upperLimit': '85'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '445', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '875', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '311', 'groupId': 'BG001'}, {'value': '607', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline Characteristics refer to all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1482}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2012-10-02', 'resultsFirstSubmitDate': '2017-01-11', 'studyFirstSubmitQcDate': '2012-10-02', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-11', 'studyFirstPostDateStruct': {'date': '2012-10-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment', 'timeFrame': 'Last 8 weeks of treatment (Weeks 44 to 52)', 'description': 'The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.'}, {'measure': 'Number of Participants Who Experience At Least One Adverse Event (AE)', 'timeFrame': 'Up to 54 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.'}, {'measure': 'Number of Participants Who Discontinue Study Drug Due to an AE', 'timeFrame': 'Up to 52 weeks', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment', 'timeFrame': 'Last 8 weeks of treatment (Weeks 44 to 52)', 'description': 'The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.'}, {'measure': 'Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment', 'timeFrame': 'Last 8 weeks of treatment (Weeks 44 to 52)', 'description': 'The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.'}, {'measure': 'Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment', 'timeFrame': 'Last 8 weeks of treatment (Weeks 44 to 52)', 'description': 'The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.'}, {'measure': 'Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment', 'timeFrame': 'Last 8 weeks of treatment (Weeks 44 to 52)', 'description': 'Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rhinitis, Allergic, Perennial', 'Rhinitis, Allergic, Nonseasonal']}, 'referencesModule': {'references': [{'pmid': '27521719', 'type': 'RESULT', 'citation': 'Nolte H, Bernstein DI, Nelson HS, Kleine-Tebbe J, Sussman GL, Seitzberg D, Rehm D, Kaur A, Li Z, Lu S. Efficacy of house dust mite sublingual immunotherapy tablet in North American adolescents and adults in a randomized, placebo-controlled trial. J Allergy Clin Immunol. 2016 Dec;138(6):1631-1638. doi: 10.1016/j.jaci.2016.06.044. Epub 2016 Aug 10.'}, {'pmid': '36924936', 'type': 'DERIVED', 'citation': 'Horn A, Bernstein DI, Okubo K, Dalgaard T, Hels O, Sorensen HF, Henriksen M, Azuma R, Mikler J, Nolte H. House dust mite sublingual immunotherapy tablet safety in adolescents with allergic rhinoconjunctivitis: Worldwide clinical trial results. Ann Allergy Asthma Immunol. 2023 Jun;130(6):797-804.e2. doi: 10.1016/j.anai.2023.03.006. Epub 2023 Mar 15.'}, {'pmid': '32926419', 'type': 'DERIVED', 'citation': 'Fortescue R, Kew KM, Leung MST. Sublingual immunotherapy for asthma. Cochrane Database Syst Rev. 2020 Sep 14;9(9):CD011293. doi: 10.1002/14651858.CD011293.pub3.'}, {'pmid': '29656145', 'type': 'DERIVED', 'citation': 'Bernstein DI, Kleine-Tebbe J, Nelson HS, Bardelas JA Jr, Sussman GL, Lu S, Rehm D, Svanholm Fogh B, Nolte H. SQ house dust mite sublingual immunotherapy tablet subgroup efficacy and local application site reaction duration. Ann Allergy Asthma Immunol. 2018 Jul;121(1):105-110. doi: 10.1016/j.anai.2018.04.007. Epub 2018 Apr 12.'}, {'pmid': '29432959', 'type': 'DERIVED', 'citation': 'Nolte H, Bernstein DI, Sussman GL, Svanholm Fogh B, Lu S, Husoy B, Nelson HS. Impact of Adverse Event Solicitation on the Safety Profile of SQ House Dust Mite Sublingual Immunotherapy Tablet. J Allergy Clin Immunol Pract. 2018 Nov-Dec;6(6):2081-2086.e1. doi: 10.1016/j.jaip.2018.01.037. Epub 2018 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of MK-8237 (SCH 900237) in the treatment of House Dust Mite (HDM)-Induced Allergic Rhinitis/Rhinoconjunctivitis (AR/ARC) in children and adults.\n\nThe primary hypothesis of this study is that administration of MK-8237, compared to placebo, results in significant reduction in the average total combined rhinitis score (TCRS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of AR/ARC to house dust of 1 year duration or more (with or without asthma)\n* If female of childbearing potential, has a negative urine pregnancy test at Screening and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study\n* Able to read, understand and complete questionnaires and diaries\n\nExclusion Criteria:\n\n* Clinically relevant history of symptomatic ARC caused by animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen\n* History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed\n* Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis)\n* Received an immunosuppressive treatment within 3 months prior to screening\n* Unstable or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists \\[SABAs\\]) at any time within 3 months prior to screening\n* Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to screening\n* History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause or inhalant allergen\n* History of chronic urticaria and/or angioedema within 2 years prior to screening\n* History of chronic sinusitis during 2 years prior to screening\n* Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study\n* Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening\n* Previous exposure to MK-8237\n* Receiving ongoing treatment with any specific immunotherapy at screening\n* Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae), rescue medications or self-injectable epinephrine\n* Unable to meet medication washout requirements prior to screening\n* Unable or unwilling to comply with the use of self-injectable epinephrine\n* Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the study\n* Likely to travel for extended periods of time during the efficacy assessment period\n* Participating in a different investigational study at any site during this study'}, 'identificationModule': {'nctId': 'NCT01700192', 'briefTitle': 'Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'A One-year Placebo-Controlled Study Evaluating the Efficacy and Safety of the House Dust Mite Sublingual Allergen Immunotherapy Tablet (SCH 900237/MK 8237) in Children and Adult Subjects With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma (Protocol No. P05607/001)', 'orgStudyIdInfo': {'id': 'P05607'}, 'secondaryIdInfos': [{'id': 'MK-8237-001', 'type': 'OTHER', 'domain': 'Merck Protocol ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-8237', 'description': 'MK-8237 12 Development Units (DU) rapidly dissolving tablets administered sublingually once daily (q.d.).', 'interventionNames': ['Biological: MK-8237 tablets', 'Drug: Rescue Medication: Self-Injectable Epinephrine', 'Drug: Rescue Medication: Loratadine tablets', 'Drug: Rescue Medication: Olopatadine ophthalmic drops', 'Drug: Rescue Medication: Mometasone furoate nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.', 'interventionNames': ['Biological: Placebo tablets', 'Drug: Rescue Medication: Self-Injectable Epinephrine', 'Drug: Rescue Medication: Loratadine tablets', 'Drug: Rescue Medication: Olopatadine ophthalmic drops', 'Drug: Rescue Medication: Mometasone furoate nasal spray']}], 'interventions': [{'name': 'MK-8237 tablets', 'type': 'BIOLOGICAL', 'otherNames': ['SCH 900237'], 'description': 'MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.', 'armGroupLabels': ['MK-8237']}, {'name': 'Placebo tablets', 'type': 'BIOLOGICAL', 'description': 'Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.', 'armGroupLabels': ['Placebo']}, {'name': 'Rescue Medication: Self-Injectable Epinephrine', 'type': 'DRUG', 'description': 'Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.', 'armGroupLabels': ['MK-8237', 'Placebo']}, {'name': 'Rescue Medication: Loratadine tablets', 'type': 'DRUG', 'description': 'Loratadine tablet 10 mg administered orally as needed for rescue medication.', 'armGroupLabels': ['MK-8237', 'Placebo']}, {'name': 'Rescue Medication: Olopatadine ophthalmic drops', 'type': 'DRUG', 'description': 'Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.', 'armGroupLabels': ['MK-8237', 'Placebo']}, {'name': 'Rescue Medication: Mometasone furoate nasal spray', 'type': 'DRUG', 'description': 'Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.', 'armGroupLabels': ['MK-8237', 'Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}