Viewing Study NCT00562094

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Ignite Creation Date: 2025-12-25 @ 1:46 AM
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Study NCT ID: NCT00562094
Status: COMPLETED
Last Update Posted: 2012-05-08
First Post: 2007-11-12
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096663', 'term': 'Non-Erosive Reflux Disease'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@nycomed.com', 'phone': '+49 7531 3666 0', 'title': 'Medical Responsible', 'organization': 'Nycomed Deutschland GmbH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From first until last visit', 'eventGroups': [{'id': 'EG000', 'title': 'Pantoprazole', 'description': 'Patients included and treated with at least one application of pantoprazole', 'otherNumAtRisk': 8616, 'otherNumAffected': 11, 'seriousNumAtRisk': 8616, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'seriousEvents': [{'term': 'Bronchial carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8616, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (12.0)'}], 'frequencyThreshold': '0.01'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Assessment of the Severity of Sleep Disturbances', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8616', 'groupId': 'OG000'}, {'value': '8616', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole / Start of Therapy', 'description': "All patients with valid values ('as observed')"}, {'id': 'OG001', 'title': 'Pantoprazole / End of Therapy', 'description': "All patients with valid values ('as observed')"}], 'classes': [{'title': 'None', 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000'}, {'value': '77.4', 'groupId': 'OG001'}]}]}, {'title': 'Mild', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000'}, {'value': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '35.9', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Severe', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '0.07', 'groupId': 'OG001'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'first and last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients included and treated, intention to treat, missing values not imputed'}, {'type': 'PRIMARY', 'title': 'Assessment of Change of Quality of Sleep During Therapy With Pantoprazole', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8616', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': "All patients with valid values ('as observed')"}], 'classes': [{'title': 'Considerably improved', 'categories': [{'measurements': [{'value': '56.2', 'groupId': 'OG000'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000'}]}]}, {'title': 'Unchanged', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with\n\n* considerably improved\n* improved\n* unchanged", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients included and treated, intention to treat, missing values not imputed'}, {'type': 'SECONDARY', 'title': 'Assessment of the Severity of Heartburn', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8540', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'Start of therapy', 'categories': [{'measurements': [{'value': '3.04', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'End of study', 'categories': [{'measurements': [{'value': '1.34', 'spread': '0.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'first and last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'SECONDARY', 'title': 'Assessment of the Severity of Eructation/Acid Eructation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8540', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'Start of therapy', 'categories': [{'measurements': [{'value': '2.66', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'End of study', 'categories': [{'measurements': [{'value': '1.29', 'spread': '0.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'first and last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'SECONDARY', 'title': 'Assessment of the Severity of Epigastric Complaints/Epigastric Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8528', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'Start of therapy', 'categories': [{'measurements': [{'value': '2.25', 'spread': '0.91', 'groupId': 'OG000'}]}]}, {'title': 'End of study', 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'first and last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'SECONDARY', 'title': 'Assessment of the Severity of Sensation of Fullness/Abdominal Distension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8516', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'All patients with valid values at first and last visit'}], 'classes': [{'title': 'Start of therapy', 'categories': [{'measurements': [{'value': '2.35', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'End of study', 'categories': [{'measurements': [{'value': '1.28', 'spread': '0.50', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'first and last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat'}, {'type': 'SECONDARY', 'title': 'Assessment of the Efficacy of Pantoprazole at Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8616', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'Patients included and treated with at least one application of pantoprazole'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '78.1', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Not satisfactory', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat'}, {'type': 'SECONDARY', 'title': 'Assessment of the Tolerability of Pantoprazole at Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8616', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole', 'description': 'Patients included and treated with at least one application of pantoprazole'}], 'classes': [{'title': 'Excellent', 'categories': [{'measurements': [{'value': '81.6', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '14.8', 'groupId': 'OG000'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Not satisfactory', 'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients included and treated with at least one application of pantoprazole (without imputation of missing values), intention to treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pantoprazole', 'description': 'All patients enrolled'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8616'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8554'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '62'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8616', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pantoprazole', 'description': 'All patients enrolled'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '14.51', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The measured value is related to the number of 8502 subjects (= valid cases). This number differs from the overall number of baseline participants due to missing data for 114 subjects.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '47.8', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '51.7', 'groupId': 'BG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Nicotine use', 'classes': [{'title': 'Smoker', 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'BG000'}]}]}, {'title': 'Non-smoker', 'categories': [{'measurements': [{'value': '64.1', 'groupId': 'BG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Alcohol use', 'classes': [{'title': 'Daily', 'categories': [{'measurements': [{'value': '22.1', 'groupId': 'BG000'}]}]}, {'title': 'Not daily', 'categories': [{'measurements': [{'value': '77.2', 'groupId': 'BG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Drug abuse', 'classes': [{'title': 'Drug abuse', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'BG000'}]}]}, {'title': 'No drug abuse', 'categories': [{'measurements': [{'value': '96.0', 'groupId': 'BG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}, {'title': 'Indication for prescription of pantoprazole', 'classes': [{'title': 'long-term therapy and/or relapse prophylaxis', 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'BG000'}]}]}, {'title': 'Acute reflux oesophagitis', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'BG000'}]}]}, {'title': 'Missing data', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'percentage of participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8616}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-04', 'studyFirstSubmitDate': '2007-11-12', 'resultsFirstSubmitDate': '2010-09-01', 'studyFirstSubmitQcDate': '2007-11-20', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-09-01', 'studyFirstPostDateStruct': {'date': '2007-11-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the Severity of Sleep Disturbances', 'timeFrame': 'first and last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe"}, {'measure': 'Assessment of Change of Quality of Sleep During Therapy With Pantoprazole', 'timeFrame': 'last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with\n\n* considerably improved\n* improved\n* unchanged"}], 'secondaryOutcomes': [{'measure': 'Assessment of the Severity of Heartburn', 'timeFrame': 'first and last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe"}, {'measure': 'Assessment of the Severity of Eructation/Acid Eructation', 'timeFrame': 'first and last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe"}, {'measure': 'Assessment of the Severity of Epigastric Complaints/Epigastric Pain', 'timeFrame': 'first and last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe"}, {'measure': 'Assessment of the Severity of Sensation of Fullness/Abdominal Distension', 'timeFrame': 'first and last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=none, 2=mild, 3=moderate, 4=severe"}, {'measure': 'Assessment of the Efficacy of Pantoprazole at Final Visit', 'timeFrame': 'last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory"}, {'measure': 'Assessment of the Tolerability of Pantoprazole at Final Visit', 'timeFrame': 'last visit (after a median of 18 days)', 'description': "Physician's assessment on a scale with 1=excellent, 2=good, 3=satisfactory, 4=not satisfactory"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pantoprazole', 'eGERD (Erosive Gastroesophageal Reflux Disease)', 'NERD (Non-Erosive Reflux Disease)', 'sleep disorders'], 'conditions': ['Erosive Gastroesophageal Reflux Disease', 'Non-Erosive Reflux Disease']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to evaluate the effect of Pantoprazole 20 mg/40 mg for 14 days on symptoms in patients with NERD (non-erosive reflux disease) or eGERD (erosive gastroesophageal reflux disease) with special focus on the reduction of symptomatic sleep disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main inclusion criteria:\n\n* GERD\n* NERD\n\nMain exclusion criteria:\n\n* Criteria as defined in the Summary of Product Characteristics'}, 'identificationModule': {'nctId': 'NCT00562094', 'acronym': 'PULS', 'briefTitle': 'Efficacy of Pantoprazole in Patients Older Than 12 Years With Reflux Associated Sleep Disorders (PULS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nycomed'}, 'officialTitle': 'Pantoprazole for the Treatment of GERD Associated Symptoms Focusing on Sleep Disorders.', 'orgStudyIdInfo': {'id': 'PAN 20/40 PULS 07/10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pantoprazole', 'interventionNames': ['Drug: Pantoprazole']}], 'interventions': [{'name': 'Pantoprazole', 'type': 'DRUG', 'description': 'This was an observational study. 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