Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-06 @ 4:05 PM
Study NCT ID:
NCT00477334
Status:
COMPLETED
Last Update Posted:
2011-03-28
First Post:
2007-05-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006558', 'term': 'Herpes Genitalis'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006561', 'term': 'Herpes Simplex'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077595', 'term': 'Famciclovir'}], 'ancestors': [{'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '21 days', 'description': 'AEs presented in this section are the AEs greater than 1% that occured in the treatment period. SAEs presented in this section are these that were reported either during the treatment or follow-up period (one SAE was reported during the follow-up period).', 'eventGroups': [{'id': 'EG000', 'title': 'Famciclovir 1000 mg', 'description': 'Famciclovir 1000 mg; twice a day for one day for treatment.', 'otherNumAtRisk': 206, 'otherNumAffected': 26, 'seriousNumAtRisk': 206, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo Comparator', 'description': 'Placebo twice a day for one day for treatment.', 'otherNumAtRisk': 98, 'otherNumAffected': 11, 'seriousNumAtRisk': 98, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood Pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Adnexa uteri pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Heart Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Radius Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pulmonary Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 206, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 98, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir 1000 mg', 'description': 'Famciclovir 1000 mg; twice a day for one day for treatment.'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'Placebo twice a day for one day for treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.38', 'groupId': 'OG000', 'lowerLimit': '3.82', 'upperLimit': '7.35'}, {'value': '4.79', 'groupId': 'OG001', 'lowerLimit': '3.56', 'upperLimit': '7.03'}]}]}], 'analyses': [{'pValue': '0.4161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.40', 'ciUpperLimit': '0.98', 'estimateComment': 'Difference in time to healing= time to healing for Famciclovir-time to healing for Placebo. Hodges-Lehman shift model is used to estimate the difference in treatment effect. P-value is from the Wilcoxon rank-sum test.', 'groupDescription': 'Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status are imputed according to the distribution of the time to healing among the subjects in the placebo group whose time to healing is greater than or equal to the observed discontinuation time. (Censor time)', 'statisticalMethod': 'Hodges-Lehman Shift Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.9372', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.01', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.39', 'estimateComment': 'Hazard ratio in time to healing=hazard rate of Famciclovir/hazard rate of Placebo.\n\nBased on Cox proportional hazards model with treatment, pooled center and gender as explanatory variables.', 'groupDescription': 'Participants who discontinued from the study before healing of non-aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non-aborted lesion stages and without a final assessment on aborted lesion status were censored at the time of the last clinical lesion observation.', 'statisticalMethod': 'Kaplan-Meier & Cox Regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '21 days', 'description': 'Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat Population (mITT) that includes all Intent to Treat participants with non-aborted genital herpes lesions during the treatment period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir 1000 mg', 'description': 'Famciclovir 1000 mg; twice a day for one day for treatment.'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'Placebo twice a day for one day for treatment.'}], 'classes': [{'title': 'Percentage with aborted lesions (n=49,20)', 'categories': [{'measurements': [{'value': '24.4', 'groupId': 'OG000'}, {'value': '20.4', 'groupId': 'OG001'}]}]}, {'title': 'Percentage with non-aborted lesions (n= 152,78)', 'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000'}, {'value': '79.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '21 days', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT). All randomized participants who initiated treatment (i.e. received any dose of the study drug) with the intention of treating genital herpes recurrences.'}, {'type': 'SECONDARY', 'title': 'Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir 1000 mg', 'description': 'Famciclovir 1000 mg; twice a day for one day for treatment.'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'Placebo twice a day for one day for treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.13', 'groupId': 'OG000', 'lowerLimit': '1.24', 'upperLimit': '6.00'}, {'value': '4.06', 'groupId': 'OG001', 'lowerLimit': '2.01', 'upperLimit': '6.64'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '21 days', 'description': 'Kaplan-Meier estimation.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT participants who discontinued from the study before healing of non aborted lesions was confirmed and participants who completed the study after 21 days since treatment initiation without non aborted lesion stages and without a final assessment on aborted lesion status were assumed as having non aborted lesions in this analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Resolution of Symptoms Associated With Recurrent Genital Herpes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir 1000 mg', 'description': 'Famciclovir 1000 mg; twice a day for one day for treatment.'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'Placebo twice a day for one day for treatment.'}], 'classes': [{'title': 'All symptoms (n=195/98)', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '8.2'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '9.0'}]}]}, {'title': 'Pain (n=141,69)', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '5.3'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '5.9'}]}]}, {'title': 'Burning (n=126,65)', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '4.4'}]}]}, {'title': 'Itching (n=168,86)', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '6.0'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '6.6'}]}]}, {'title': 'Tingling (n=141,70)', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.2'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '5.9'}]}]}, {'title': 'Tenderness (n=147/74)', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '6.5'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '72 hour after initiation of study medication up to 21 days', 'description': 'Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population. If a participant never had a symptom prior to the last valid diary entry for the first recurrence, then the time to resolution of the symptom was set to missing and the participant was not included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir 1000 mg', 'description': 'Famciclovir 1000 mg; twice a day for one day for treatment.'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'Placebo twice a day for one day for treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Number of participants with a second recurrence of genital herpes in the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population: participants who completed the first recurrence.'}, {'type': 'SECONDARY', 'title': 'Time to Second Recurrence of Genital Herpes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Famciclovir 1000 mg', 'description': 'Famciclovir 1000 mg; twice a day for one day for treatment.'}, {'id': 'OG001', 'title': 'Placebo Comparator', 'description': 'Placebo twice a day for one day for treatment.'}], 'classes': [{'title': 'Time from initiation of treatment', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '31.0', 'upperLimit': '143.0'}, {'value': '81.0', 'groupId': 'OG001', 'lowerLimit': '31.0', 'upperLimit': '122.0'}]}]}, {'title': 'Time from healing of non-aborted lesion', 'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '137.0'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '118.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Population: participants who completed the first recurrence.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '304', 'groupId': 'OG002'}, {'value': '304', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Grade 1 Toxicity'}, {'id': 'OG001', 'title': 'Grade 2 Toxicity'}, {'id': 'OG002', 'title': 'Grade 3 Toxicity'}, {'id': 'OG003', 'title': 'Grade 4 Toxicity'}], 'classes': [{'title': 'Haematocrit-Famciclovir (n=186)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Haematocrit-Placebo (n=87)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Haemoglobin-Famciclovir (n=183)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Haemoglobin-Placebo(n=88)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Absolute Neutrophils-Famciclovir (n=177)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Absolute Neutrophils-Placebo (n=83)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC(total)-Famciclovir (n=163)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC(total)-Placebo(n=98)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelet count-Famciclovir (n=184)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Platelet count-Placebo (n=88)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 2', 'description': 'The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.'}, {'type': 'SECONDARY', 'title': 'The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}, {'value': '304', 'groupId': 'OG002'}, {'value': '304', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Grade 1 Toxicity'}, {'id': 'OG001', 'title': 'Grade 2 Toxicity'}, {'id': 'OG002', 'title': 'Grade 3 Toxicity'}, {'id': 'OG003', 'title': 'Grade 4 Toxicity'}], 'classes': [{'title': 'SGPT(ALT)-Famciclovir (n=183)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'SGPT(ALT)-Placebo (n=92)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'SGOT(AST)-Famciclovir (n=190)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'SGOT(AST)-Placebo (n=92)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood Urea Nitrogen-Famciclovir (n=196)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Blood Urea Nitrogen-Placebo (n=95)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine-Famciclovir (n=182)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine-Placebo (n=90)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin(total)-Famciclovir (n=192)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin(total)-Placebo (n=93)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Amylase-Famciclovir (n=152)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Amylase-Placebo (n=72)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lipase-Famciclovir (n=190)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lipase-Placebo (n=90)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 2', 'description': 'The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.\n\nSGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '304 Participants = 206 participants in the Famciclovir Group + 98 participants in the Placebo Group. Individual n values in each of the categories is the number of participants in the group with normal baseline values and at least one non-missing post baseline measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Famciclovir 1000 mg', 'description': 'Famciclovir 1000 mg; twice a day for one day for treatment.'}, {'id': 'FG001', 'title': 'Placebo Comparator', 'description': 'Placebo twice a day for one day for treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '312'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'Randomized and Took Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'Intent to Treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}, {'groupId': 'FG001', 'numSubjects': '98'}]}, {'type': 'Participants Completing First Recurrence', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'Modified Intent to Treat Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants completing the first recurrence and follow-up.', 'groupId': 'FG000', 'numSubjects': '142'}, {'comment': 'Participants completing the first recurrence and follow-up.', 'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '170'}, {'groupId': 'FG001', 'numSubjects': '76'}]}], 'dropWithdraws': [{'type': 'Discontinued prior to taking study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Administrative Problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Famciclovir 1000 mg', 'description': 'Famciclovir 1000 mg; twice a day for one day for treatment.'}, {'id': 'BG001', 'title': 'Placebo Comparator', 'description': 'Placebo twice a day for one day for treatment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.5', 'spread': '10.35', 'groupId': 'BG000'}, {'value': '38.5', 'spread': '10.34', 'groupId': 'BG001'}, {'value': '37.8', 'spread': '10.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Intent to Treat population consists of all randomized participants who initiated treatment with the study drug with the intention of treating genital herpes recurrences', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '196', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Intent to Treat population consists of all randomized patients who initiated treatment with the study drug with the intention of treating genital herpes recurrences', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Years: recurrent genital herpes', 'classes': [{'categories': [{'measurements': [{'value': '6.9', 'spread': '6.75', 'groupId': 'BG000'}, {'value': '7.0', 'spread': '6.50', 'groupId': 'BG001'}, {'value': '7.0', 'spread': '6.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of years the participant has experienced recurrent genital herpes. Intent to Treat population consists of all randomized participants who initiated treatment with the study drug with the intention of treating genital herpes recurrences', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Genital herpes recurrence in last 12 months', 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '3.26', 'groupId': 'BG000'}, {'value': '5.8', 'spread': '2.72', 'groupId': 'BG001'}, {'value': '5.9', 'spread': '3.09', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of genital herpes recurrences during the last 12 months or in the 12 months immediately preceding suppressive treatment.\n\nIntent to Treat population consists of all randomized participants who initiated treatment with the study drug with the intention of treating genital herpes recurrences', 'unitOfMeasure': 'Genital herpes recurrences', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 463}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-24', 'studyFirstSubmitDate': '2007-05-22', 'resultsFirstSubmitDate': '2010-12-15', 'studyFirstSubmitQcDate': '2007-05-22', 'lastUpdatePostDateStruct': {'date': '2011-03-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-02-22', 'studyFirstPostDateStruct': {'date': '2007-05-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions', 'timeFrame': '21 days', 'description': 'Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period', 'timeFrame': '21 days'}, {'measure': 'Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions', 'timeFrame': '21 days', 'description': 'Kaplan-Meier estimation.'}, {'measure': 'Time to Resolution of Symptoms Associated With Recurrent Genital Herpes', 'timeFrame': '72 hour after initiation of study medication up to 21 days', 'description': 'Median time to resolution of symptoms: all symptoms, pain, burning, itching, tingling and tenderness associated with recurrent genital herpes estimated using Kaplan-Meier method.'}, {'measure': 'Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period', 'timeFrame': '6 months', 'description': 'Number of participants with a second recurrence of genital herpes in the follow-up period.'}, {'measure': 'Time to Second Recurrence of Genital Herpes', 'timeFrame': '6 months', 'description': 'Kaplan Meier estimated time in days to second recurrent from treatment initiation and from the date of healing of aborted lesions.'}, {'measure': 'The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment', 'timeFrame': 'Baseline, Day 2', 'description': 'The number of participants with clinically noted shifts in Hematology tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.'}, {'measure': 'The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment', 'timeFrame': 'Baseline, Day 2', 'description': 'The number of participants with clinically noted shifts in Clinical Chemistry tests from normal at baseline are graded based on Division of Microbiology and Infectious Diseases (DMID) toxicity tables from Grade 1 toxicity (smallest change) to Grade 4 toxicity (largest change). Grade 3 and 4 toxicities are considered to be clinically meaningful.\n\nSGPT(ALT)= Serum Glutamic Pyruvate Transaminase (Alanine Aminotransferase) and SGOT(AST)= Serum Glutamic Oxalacetic Transaminase (Aspartate Aminotransferase)'}]}, 'conditionsModule': {'keywords': ['Recurrent genital herpes', 'Black population'], 'conditions': ['Genital Herpes']}, 'referencesModule': {'references': [{'pmid': '20070143', 'type': 'DERIVED', 'citation': 'Leone P, Abudalu M, Mitha E, Gani M, Zhou W, Hamed K. One-day famciclovir vs. placebo in patient-initiated episodic treatment of recurrent genital herpes in immunocompetent Black patients. Curr Med Res Opin. 2010 Mar;26(3):653-61. doi: 10.1185/03007990903554471.'}], 'seeAlsoLinks': [{'url': 'http://www.novartisclinicaltrials.com/webapp/etrials/DiseaseID58/Genital-Herpes-clinical-trials.go', 'label': 'Click here for more information on this study'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Black men or women 18 years or older\n* History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy\n* Documented herpes simplex virus type 2 (HSV-2) seropositivity\n* Willingness to discontinue suppressive therapy during study, if applicable\n* Willingness and ability to comply with the study protocol\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Women of childbearing potential not using accepted methods of contraception\n* Hypersensitivity to famciclovir or drugs with similar chemical structures\n* Renal dysfunction\n* Known or suspected to have decompensated liver disease\n* Known to have gastrointestinal malabsorption\n* Known to be immunocompromised\n* Known to be hypersensitive to ingredients in study medication\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00477334', 'briefTitle': 'Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Multicenter, Double-blind Study to Compare the Efficacy of Single-day Treatment (1000 mg b.i.d.) With Famciclovir Compared to That of Placebo in Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Immunocompetent Black Patients', 'orgStudyIdInfo': {'id': 'CFAM810A2310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Famciclovir 1000 mg; twice a day for one day.', 'interventionNames': ['Drug: Famciclovir']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo; twice a day for one day.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Famciclovir', 'type': 'DRUG', 'otherNames': ['Famvir'], 'description': 'oral; two 500 mg tablets twice a day; single day treatment', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral; two tablets twice a day; single day treatment', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Clinical Research', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '90255', 'city': 'Huntington Park', 'state': 'California', 'country': 'United States', 'facility': 'Alia Clinical Research, INC', 'geoPoint': {'lat': 33.98168, 'lon': -118.22507}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Dermatology Research Associates', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94114', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'The Conant Foundation Quest Diagnostics', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Medical Research Centers of South Florida, Inc.', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32208', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'First Coast Primary Care Minority Physicians Research Alliance', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'AppleMed Research Inc.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33156', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'International Research Associates, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33161', 'city': 'North Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Segal Institute for Clinical Research Heathcare Clinical Data, Inc', 'geoPoint': {'lat': 25.89009, 'lon': -80.18671}}, {'zip': '30338', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Perimeter Institute for Clinical Research Inc. 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