Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT00255151
Status:
COMPLETED
Last Update Posted:
2012-02-03
First Post:
2005-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004942', 'term': 'Esophagitis, Peptic'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064748', 'term': 'Dexlansoprazole'}, {'id': 'D064747', 'term': 'Lansoprazole'}], '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': 'clinicaltrialregistry@tpna.com', 'phone': '800-778-2860', 'title': 'Sr. VP Clinical Sciences', 'organization': 'Takeda Global Research and Development Center, Inc.'}, 'certainAgreement': {'otherDetails': 'No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 6 months.', 'otherNumAffected': 7, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.', 'otherNumAffected': 33, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.', 'otherNumAffected': 25, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhoea (Excluding [Excl] Infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Flatulence, Bloating and Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastritis (Excl Infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastrointestinal and Abdominal Pains (Excl Oral and Throat)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Upper Respiratory Tract Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'seriousEvents': [{'term': 'Coronary Artery Disorders Not Elsewhere Classified (NEC)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Acute and Chronic Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pain and Discomfort NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Non-site Specific Injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Musculoskeletal and Connective Tissue Signs and Symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Breast and Nipple Neoplasms Malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Uterine Disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 140, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 152, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '138', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 6 months.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.'}, {'id': 'OG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '8.4', 'upperLimit': '22.2'}, {'value': '66.4', 'groupId': 'OG001', 'lowerLimit': '58.3', 'upperLimit': '73.9'}, {'value': '64.5', 'groupId': 'OG002', 'lowerLimit': '55.9', 'upperLimit': '72.4'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.00001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': "Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.80473', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The crude rate analysis was performed on intent-to-treat (ITT) subjects (subjects from Studies T-EE04-084 or T-EE04-085 with endoscopically proven healed EE who received at least 1 dose of study drug in this study and did not have a gap of \\>7 days between the EE healing studies and this study) with at least one endoscopy in this maintenance study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 6 months.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.'}, {'id': 'OG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'spread': '29.3', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '52.0'}, {'value': '95.8', 'spread': '30.7', 'groupId': 'OG001', 'lowerLimit': '76.9', 'upperLimit': '99.1'}, {'value': '94.4', 'spread': '30.0', 'groupId': 'OG002', 'lowerLimit': '67.1', 'upperLimit': '99.4'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.00001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': "The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.76046', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.', 'unitOfMeasure': 'Percentage of Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 6 months.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.'}, {'id': 'OG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '29.3', 'groupId': 'OG000'}, {'value': '79.7', 'spread': '30.7', 'groupId': 'OG001'}, {'value': '79.2', 'spread': '30.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked', 'unitOfMeasure': 'Percentage of Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis of 24-hour heartburn-free days was performed on ITT subjects with at least one daytime or nighttime heartburn Yes/No question answered during treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '152', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 6 months.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.'}, {'id': 'OG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000'}, {'value': '86.6', 'groupId': 'OG001'}, {'value': '82.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.00001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': "Hochberg's method was used to ensure that the overall 0.0025 level of significance was maintained for the pairwise comparisons between each dexlansoprazole MR dose and placebo.", 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.37161', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Statistical significance was determined at 0.0025 level without adjustment for multiple comparisons.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.', 'unitOfMeasure': 'Percentage of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Life table method for the maintenance rate of healed EE was performed on ITT subjects and included subjects without post-baseline endoscopy as censored.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 6 months.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.'}, {'id': 'OG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.0', 'spread': '35.3', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '81.3'}, {'value': '98.3', 'spread': '25.5', 'groupId': 'OG001', 'lowerLimit': '90.6', 'upperLimit': '100.0'}, {'value': '97.1', 'spread': '26.3', 'groupId': 'OG002', 'lowerLimit': '83.3', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '<0.00001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': "The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.00001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': "The 0.0025 level of significance for this secondary endpoint was controlled using Hochberg's method for comparisons of each dexlansoprazole MR dose to placebo.", 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.59700', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'Statistical significance was determined at the 0.0025 level without adjustment for multiple comparisons.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.', 'unitOfMeasure': 'Percentage of Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 6 months.'}, {'id': 'OG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.'}, {'id': 'OG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'spread': '35.3', 'groupId': 'OG000'}, {'value': '87.1', 'spread': '25.5', 'groupId': 'OG001'}, {'value': '85.4', 'spread': '26.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.', 'unitOfMeasure': 'Percentage of Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on ITT subjects with at least one nighttime heartburn Yes/No question answered during treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 6 months.'}, {'id': 'FG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.'}, {'id': 'FG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '140'}, {'groupId': 'FG001', 'numSubjects': '159'}, {'groupId': 'FG002', 'numSubjects': '152'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '110'}, {'groupId': 'FG002', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '49'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Subject Request/Subject Unavailable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Relapse of Erosive Esophagitis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': "Possible Barrett's Esophagus", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Esophageal Stricture', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Therapeutic Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at 105 sites in the United States; date of first dose (04 January 2006; date of last procedure: 14 November 2006).', 'preAssignmentDetails': 'Subjects had to have endoscopically proven healed erosive esophagitis (EE) after 4 to 8 weeks of treatment with lansoprazole 30 mg once-daily (QD), dexlansoprazole modified release (MR) 60 mg QD, or dexlansoprazole MR 90 mg QD in the EE healing studies, T-EE04-084 (NCT00251693) and T-EE04-085 (NCT00251719).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '451', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo QD', 'description': 'Placebo capsules, orally, once daily for up to 6 months.'}, {'id': 'BG001', 'title': 'Dexlansoprazole MR 60 mg QD', 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.'}, {'id': 'BG002', 'title': 'Dexlansoprazole MR 90 mg QD', 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'spread': '12.88', 'groupId': 'BG000'}, {'value': '49.7', 'spread': '12.66', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '13.76', 'groupId': 'BG002'}, {'value': '48.9', 'spread': '13.09', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<45 years', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}, {'title': '45 to <65 years', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '248', 'groupId': 'BG003'}]}]}, {'title': '≥65 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '216', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}, {'value': '235', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '395', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '403', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Los Angeles (LA) Classification Grade for Erosive Esophagitis (EE)', 'classes': [{'title': 'A: ≥1 mucosal break <5 mm', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '172', 'groupId': 'BG003'}]}]}, {'title': 'B: ≥1 mucosal break ≥5 mm', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '167', 'groupId': 'BG003'}]}]}, {'title': 'C: ≥1 mucosal break <75% of circumference', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}, {'title': 'D: ≥1 mucosal break ≥75% of circumference', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Baseline values from Studies T-EE04-084 (NCT00251693)and T-EE04-085 (NCT00251719), with severity of EE increasing from Grade A to Grade D.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 451}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-01', 'studyFirstSubmitDate': '2005-11-15', 'resultsFirstSubmitDate': '2009-02-20', 'studyFirstSubmitQcDate': '2005-11-15', 'lastUpdatePostDateStruct': {'date': '2012-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-07-20', 'studyFirstPostDateStruct': {'date': '2005-11-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Crude Rate Analysis.', 'timeFrame': '6 months', 'description': 'Crude rates analyzed maintenance of healed EE from baseline of this study and considered prematurely discontinued subjects as relapsed.'}, {'measure': 'Percentage of Subjects Who Maintained Complete Healing of Erosive Esophagitis as Assessed by Endoscopy - Life Table Method', 'timeFrame': '6 months', 'description': 'Percentage of subjects who maintained complete healing of erosive esophagitis as assessed by endoscopy. In the life table method, subjects without post-baseline endoscopy were included as censored; subjects who did not have a recurrence of EE and did not complete the study were also considered censored.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Median.', 'timeFrame': '6 months', 'description': 'The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was reported.'}, {'measure': 'Percentage of Days Without Daytime or Nighttime Heartburn as Assessed by Daily Diary-Mean.', 'timeFrame': '6 months', 'description': 'The percentage was calculated as the days that were heartburn-free out of the total number of days for which either a daytime or nighttime result was marked'}, {'measure': 'Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Median.', 'timeFrame': '6 months', 'description': 'The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.'}, {'measure': 'Percentage of Days Without Nighttime Heartburn as Assessed by Daily Diary-Mean.', 'timeFrame': '6 months', 'description': 'The percentage was calculated as the nights that were heartburn-free out of the total number of days for which a nighttime result was marked.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erosive Esophagitis'], 'conditions': ['Esophagitis, Reflux', 'Esophagitis, Peptic']}, 'referencesModule': {'references': [{'pmid': '19681809', 'type': 'RESULT', 'citation': 'Howden CW, Larsen LM, Perez MC, Palmer R, Atkinson SN. Clinical trial: efficacy and safety of dexlansoprazole MR 60 and 90 mg in healed erosive oesophagitis - maintenance of healing and symptom relief. Aliment Pharmacol Ther. 2009 Nov 1;30(9):895-907. doi: 10.1111/j.1365-2036.2009.04119.x. Epub 2009 Aug 14.'}], 'seeAlsoLinks': [{'url': 'http://general.takedapharm.com/content/file/pi.pdf?applicationcode=9efb34b3-fb69-4190-a2be-a90b8cb94e25&filetypecode=DEXILANTPI', 'label': 'For the Dexilant package insert refer to this link'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the ability of once-daily (QD) treatment with Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of erosive esophagitis (EE).', 'detailedDescription': 'This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 6 month maintenance study. The study is designed to compare the efficacy and safety of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo, in maintaining healing of erosive esophagitis.\n\nBecause the development plan for Dexlansoprazole MR formulation was revised, the results of 2 identical studies, T-EE04-086 (NCT00255164) and T-EE04-087 (this study, NCT00255151), were combined and analyzed as a single larger study referred to as study T-EE04-086. A total of 451 subjects were included in the combined analysis: 237 subjects were enrolled into Study T-EE04-086, and 214 subjects were enrolled into Study T-EE04-087.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693) or T-EE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy. Complete healing was assessed for change in LA Esophagitis Classification grades A, B, C, or D to healed (defined as anything less than the criterion for Grade A). The subject was counted as healed if endoscopy findings did not meet the Grade A criterion.\n\nExclusion Criteria:\n\n* Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study\n* Use of antacids (except for study supplied) throughout the study.\n* Subjects using drugs with significant anticholinergic effects such as tricyclics who cannot stay on a stable dose throughout the study.\n* Need for continuous anticoagulant therapy.'}, 'identificationModule': {'nctId': 'NCT00255151', 'briefTitle': 'Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 3 Study to Evaluate the Safety and Efficacy of Dexlansoprazole MR (60 mg QD and 90 mg QD) Compared to Placebo in Maintenance of Healing in Subjects With Healed Erosive Esophagitis', 'orgStudyIdInfo': {'id': 'T-EE04-087'}, 'secondaryIdInfos': [{'id': 'U1111-1114-1767', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexlansoprazole MR 60 mg QD', 'interventionNames': ['Drug: Dexlansoprazole MR']}, {'type': 'EXPERIMENTAL', 'label': 'Dexlansoprazole MR 90 mg QD', 'interventionNames': ['Drug: Dexlansoprazole MR']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dexlansoprazole MR', 'type': 'DRUG', 'otherNames': ['TAK-390MR', 'Dexilant', 'Kapidex'], 'description': 'Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.', 'armGroupLabels': ['Dexlansoprazole MR 60 mg QD']}, {'name': 'Dexlansoprazole MR', 'type': 'DRUG', 'otherNames': ['TAK-390MR', 'Kapidex', 'Dexilant'], 'description': 'Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.', 'armGroupLabels': ['Dexlansoprazole MR 90 mg QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'city': 'Hueytown', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.45122, 'lon': -86.99666}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Tallassee', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 32.53597, 'lon': -85.89329}}, {'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Little Rock', 'state': 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