Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT01125605
Status:
COMPLETED
Last Update Posted:
2015-04-14
First Post:
2010-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'klinische.forschung@pascoe.de', 'phone': '0049 641 7960100', 'title': 'Director of Clinical Trials', 'organization': 'Pascoe pharmazeutische Praeparate GmbH'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'after appr. 2 weeks and after appr. 4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Observational Group', 'description': 'Pasconal Nerventropfen', 'otherNumAtRisk': 326, 'otherNumAffected': 14, 'seriousNumAtRisk': 326, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'gastrointestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'tiredness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'heartburn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'aggressivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'stomach ache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'tongue and mucosa under tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 326, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '0.1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}, {'value': '309', 'groupId': 'OG002'}, {'value': '325', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1', 'description': 'Observational group (Pasconal Nerventropfen) at visit 1'}, {'id': 'OG001', 'title': 'Visit 2', 'description': 'Observational group (Pasconal Nerventropfen) at visit 2'}, {'id': 'OG002', 'title': 'Visit 3', 'description': 'Observational group (Pasconal Nerventropfen) at visit 3'}, {'id': 'OG003', 'title': 'Last Observation', 'description': 'Observational group (Pasconal Nerventropfen) at last observation'}], 'classes': [{'categories': [{'measurements': [{'value': '15.8', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '4.5', 'groupId': 'OG002'}, {'value': '6.2', 'spread': '5.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)', 'description': 'The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'descriptive; for all partcipations with values at the visits'}, {'type': 'SECONDARY', 'title': 'Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'OG000'}, {'value': '325', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1', 'description': 'Observational group (Pasconal Nerventropfen) at visit 1'}, {'id': 'OG001', 'title': 'Last Observation', 'description': 'Observational group (Pasconal Nerventropfen) at last observation'}], 'classes': [{'title': 'with concomitant medication', 'categories': [{'measurements': [{'value': '15.9', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'without concomitant medication', 'categories': [{'measurements': [{'value': '15.7', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': '< 4 weeks treatment duration', 'categories': [{'measurements': [{'value': '14.3', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '6.0', 'groupId': 'OG001'}]}]}, {'title': '>= 4 weeks treatment duration', 'categories': [{'measurements': [{'value': '16.1', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '4.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0033', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'decrease of the sum score between baseline (visit 1) and last observation was exploratively analysed', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate', 'testedNonInferiority': False}, {'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'decrease of the sum score between baseline (visit1) and last observation by duration of treatment', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'ANCOVA with GLM (Generalized Linear Model) of SAS® (with type III sums of squares); including the baseline value of the sum score as a covariate', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))', 'description': 'The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).\n\nDecrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (\\< 4 weeks and \\>= 4 weeks)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'exploratively, all participations with values'}, {'type': 'SECONDARY', 'title': 'Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With Concomitant Medication', 'description': 'Observational group (Pasconal Nerventropfen) with concomitant medication'}, {'id': 'OG001', 'title': 'Without Concomitant Medication', 'description': 'Observational group (Pasconal Nerventropfen) without concomitant medication'}], 'classes': [{'title': 'improved', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}]}, {'title': 'unchanged', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'worsened', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0014', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))', 'description': 'The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \\> 0).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'exploratively, all participations with values'}, {'type': 'SECONDARY', 'title': 'Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '< 4 Weeks', 'description': 'Observational group (Pasconal Nerventropfen) with a treatment duration \\< 4 weeks'}, {'id': 'OG001', 'title': '> = 4 Weeks', 'description': 'Observational group (Pasconal Nerventropfen) with a treatment duration \\>= 4 weeks'}], 'classes': [{'title': 'improved', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}]}, {'title': 'unchanged', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'worsened', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0125', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))', 'description': 'The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \\> 0).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'exploratively, all participations with values'}, {'type': 'SECONDARY', 'title': 'Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With Concomitant Medication', 'description': 'Observational group (Pasconal Nerventropfen) with concomitant medication'}, {'id': 'OG001', 'title': 'Without Concomitant Medication', 'description': 'Observational group (Pasconal Nerventropfen) without concomitant medication'}], 'classes': [{'title': 'improved', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}]}, {'title': 'unchanged', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'worsened', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))', 'description': 'The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \\> 0).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'exploratively, all participations with values'}, {'type': 'SECONDARY', 'title': 'Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '< 4 Weeks', 'description': 'Observational group (Pasconal Nerventropfen) with a treatment duration \\< 4 weeks'}, {'id': 'OG001', 'title': '> = 4 Weeks', 'description': 'Observational group (Pasconal Nerventropfen) with a treatment duration \\>= 4 weeks'}], 'classes': [{'title': 'improved', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}]}, {'title': 'unchanged', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'worsened', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))', 'description': 'The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \\> 0).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'exploratively, all participations with values'}, {'type': 'SECONDARY', 'title': 'Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'With Concomitant Medication', 'description': 'Observational group (Pasconal Nerventropfen) with concomitant medication'}, {'id': 'OG001', 'title': 'Without Concomitant Medication', 'description': 'Observational group (Pasconal Nerventropfen) without concomitant medication'}], 'classes': [{'title': 'PASCONAL better', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}, {'title': 'No difference', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'PACONAL worse', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0504', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)', 'description': 'Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.\n\nThe last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'exploratively, all participations with values'}, {'type': 'PRIMARY', 'title': 'Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '293', 'groupId': 'OG002'}, {'value': '308', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1', 'description': 'Observational group (Pasconal Nerventropfen) at visit 1'}, {'id': 'OG001', 'title': 'Visit 2', 'description': 'Observational group (Pasconal Nerventropfen) at visit 2'}, {'id': 'OG002', 'title': 'Visit 3', 'description': 'Observational group (Pasconal Nerventropfen) at visit 1'}, {'id': 'OG003', 'title': 'Last Observation', 'description': 'Observational group (Pasconal Nerventropfen) at last observation'}], 'classes': [{'title': '0=not present', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '79', 'groupId': 'OG003'}]}]}, {'title': '1=mild', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}, {'value': '180', 'groupId': 'OG002'}, {'value': '789', 'groupId': 'OG003'}]}]}, {'title': '2=moderate', 'categories': [{'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}]}, {'title': '3=Strong', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)', 'description': 'The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'descriptive; for all partcipations with values at the visits'}, {'type': 'SECONDARY', 'title': 'Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '< 4 Weeks', 'description': 'Observational group (Pasconal Nerventropfen) with concomitant medication'}, {'id': 'OG001', 'title': '>= 4 Weeks', 'description': 'Observational group (Pasconal Nerventropfen) without concomitant medication'}], 'classes': [{'title': 'PASCONAL better', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}]}, {'title': 'No difference', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'PACONAL worse', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)', 'description': 'Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.\n\nThe last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'exploratively, all participations with values'}, {'type': 'PRIMARY', 'title': 'Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}, {'value': '293', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 1', 'description': 'Observational group (Pasconal Nerventropfen) at visit 1'}, {'id': 'OG001', 'title': 'Visit 2', 'description': 'Observational group (Pasconal Nerventropfen) at visit 2'}, {'id': 'OG002', 'title': 'Visit 3', 'description': 'Observational group (Pasconal Nerventropfen) at visit 1'}, {'id': 'OG003', 'title': 'Last Observation', 'description': 'Observational group (Pasconal Nerventropfen) at last observation'}], 'classes': [{'title': '0=not present', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '111', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}]}]}, {'title': '1=mild', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '142', 'groupId': 'OG003'}]}]}, {'title': '2=moderate', 'categories': [{'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': '3=Strong', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)', 'description': 'The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'descriptive; for all partcipations with values at the visits'}, {'type': 'PRIMARY', 'title': 'Tolerability After Visit 2 and Visit 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '326', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Visit 2', 'description': 'Observational group (Pasconal Nerventropfen) at visit 2'}, {'id': 'OG001', 'title': 'Visit 3', 'description': 'Observational group (Pasconal Nerventropfen) at visit 3'}], 'classes': [{'title': 'well tolerated', 'categories': [{'measurements': [{'value': '313', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}]}, {'title': 'poor tolerated', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)', 'description': 'Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'descriptive; for safety 326 patients were analysed; 1 patient had no efficacy values and were not analysed for efficacy; so a discrepancy between 325 patients (for efficacy) and 326 (for safety) occured'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Observational Group', 'description': 'Pasconal Nerventropfen PASCONAL® NERVENTROPFEN is a homoeopathic combination product (oral drops) consisting out of 4 ingredients: Avena sativa, Valeriana, Ignatia and Tarantula.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'started = had baseline values', 'groupId': 'FG000', 'numSubjects': '325'}]}, {'type': 'Safety', 'achievements': [{'comment': '1 patient was only analysed for safety', 'groupId': 'FG000', 'numSubjects': '326'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '325'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Physicians who were registered in the past with the treatment focus on central nervous system / psyche. The recruitment of the participating physicians was done by the field service of PASCOE.', 'preAssignmentDetails': 'It was an non-inteventional observational study with 3 visits.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '325', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Observational Group', 'description': 'Pasconal Nerventropfen'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '212', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '229', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant medication', 'classes': [{'title': 'with concomitant medication', 'categories': [{'measurements': [{'value': '176', 'groupId': 'BG000'}]}]}, {'title': 'without concomitant medication', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Duration of disease years', 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '3.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'State of inclusion diagnosis', 'classes': [{'title': 'acute (<= 2 months)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}, {'title': 'subchronic/chronic (> 2 months)', 'categories': [{'measurements': [{'value': '163', 'groupId': 'BG000'}]}]}, {'title': 'missing data', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The duration of complaints was divided into two groups to the extent this was possible:\n\n* Acute disease (duration of symptoms ≤2 months)\n* Subchronic and/or chronic disease (duration of symptoms \\>2 months)', 'unitOfMeasure': 'participants'}, {'title': 'Previous treatment of inclusion diagnosis', 'classes': [{'title': 'with previous treatment of inclusion diagnosis', 'categories': [{'measurements': [{'value': '245', 'groupId': 'BG000'}]}]}, {'title': 'without previous treatment of inclusion diagnosis', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Within the range of the observational study, it was ascertained whether the inclusion diagnosis had been treated previously.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '2010-05-10', 'resultsFirstSubmitDate': '2012-07-18', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-07-18', 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3', 'timeFrame': 'begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)', 'description': 'The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).'}, {'measure': 'Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation', 'timeFrame': 'begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)', 'description': 'The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).'}, {'measure': 'Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation', 'timeFrame': 'begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)', 'description': 'The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).'}, {'measure': 'Tolerability After Visit 2 and Visit 3', 'timeFrame': 'appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)', 'description': 'Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects'}], 'secondaryOutcomes': [{'measure': 'Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration', 'timeFrame': 'begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3))', 'description': 'The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).\n\nDecrease of the sumscore between baseline and last observation by concomitant medication (with and withour medication) and treatment duration (\\< 4 weeks and \\>= 4 weeks)'}, {'measure': 'Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication', 'timeFrame': 'begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))', 'description': 'The symptom nervousness/restlessnesswas analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \\> 0).'}, {'measure': 'Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment', 'timeFrame': 'begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))', 'description': 'The symptom nervousness/restlessness was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \\> 0).'}, {'measure': 'Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication', 'timeFrame': 'begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))', 'description': 'The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \\> 0).'}, {'measure': 'Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment', 'timeFrame': 'begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3))', 'description': 'The symptom irritability/eccentricity was analysed with respect to the direction of change between baseline (Visit 1) and the last documented visit (Visit 2 or Visit 3) by means of the categories "improved", "unchanged" and "worsened". For each symptom patients were included in the analysis only if the symptom had been present at Visit 1 (i.e. the baseline score value was \\> 0).'}, {'measure': 'Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)', 'timeFrame': 'appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)', 'description': 'Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.\n\nThe last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".'}, {'measure': 'Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration', 'timeFrame': 'appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3)', 'description': 'Efficacy of the therapy with PASCONAL® NERVENTROPFEN was rated by the physician on a 4-point rating scale at Visit 2 and Visit 3. The same scale was applied at Visit 1 for evaluation of the efficacy of the previous medication.\n\nThe last evaluation for PASCONAL® NERVENTROPFEN (Visit 2 or Visit 3, according to the LOCF principle) was compared with the rating for the previous therapy by means of the categories "PASCONAL® better", "No difference" and "PASCONAL® worse".'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PASCONAL', 'nervousness', 'nervosity', 'sleep disorder'], 'conditions': ['Nervousness', 'Sleep Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.', 'detailedDescription': 'The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.\n\nEfficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management, dose regimen, and to the effectiveness and safety in special patient groups (children 1-12 years of age), in relation to treatment conformity to the Summary of Product Characteristics (SmPC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Observational groups\n\nPatients (adults and children 1-12 years of age) suffering from nervous diseases, e.g. sleep-disturbances due to nervousness.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Due to the design as an Observational Study no inclusion or exclusion criteria for therapy are named. The included patient group is described under "Cohort / Group".\n\nObservational Criteria (=inclusion criteria for documentation):\n\n* Males and females\n* Children 1-12 years old\n* Adults \\>12 years old\n* suffering from nervous diseases, e.g. sleep disorders due to nervousness.\n\nExclusion criteria for documentation:\n\n* children younger than 1 year\n* no nervous diseases, e.g. sleep disorders due to nervousness.\n* no treatment with PASCONAL NERVENTROPFEN'}, 'identificationModule': {'nctId': 'NCT01125605', 'acronym': '174', 'briefTitle': 'PASCONAL NERVENTROPFEN in the Treatment of Nervous Diseases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pascoe Pharmazeutische Praeparate GmbH'}, 'officialTitle': 'PASCONAL NERVENTROPFEN in the Treatment of Adults and Children Suffering From Nervous Diseases (e.g. Sleep Disorders Due to Nervousness)', 'orgStudyIdInfo': {'id': '174A10PNAL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults > 12 years', 'description': 'adult patients and patients older than 12 years'}, {'label': 'Children 6-12 years', 'description': 'children between 6 and 12 years'}, {'label': 'Children 1-6 years', 'description': 'children between 1 and 6 years'}]}, 'contactsLocationsModule': {'locations': [{'city': 'All Over Germany', 'country': 'Germany', 'facility': 'Multiple German Practices'}], 'overallOfficials': [{'name': 'Bianka Krick', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pascoe Pharmazeutische Praeparate GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pascoe Pharmazeutische Praeparate GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}