Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT00994461
Status:
COMPLETED
Last Update Posted:
2021-02-02
First Post:
2009-10-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Of Celecoxib In Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}, {'id': 'C040656', 'term': 'loxoprofen'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Celecoxib', 'description': 'Celecoxib 100 mg tablet twice a day with meal for 2 weeks', 'otherNumAtRisk': 76, 'otherNumAffected': 19, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Loxoprofen', 'description': 'Loxoprofen 60 mg tablet three times a day with meal for 2 weeks', 'otherNumAtRisk': 76, 'otherNumAffected': 37, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo tablet three times a day with meal for 2 weeks', 'otherNumAtRisk': 37, 'otherNumAffected': 8, 'seriousNumAtRisk': 37, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Erosive duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 76, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Gastroduodenal Ulcers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib 100 mg tablet twice a day with meal for 2 weeks'}, {'id': 'OG001', 'title': 'Loxoprofen', 'description': 'Loxoprofen 60 mg tablet three times a day with meal for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet three times a day with meal for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '27.6', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Cochran-Mantel-Haenszel (CMH) test stratified by H. pylori status was employed for the comparison of celecoxib and loxoprofen with placebo. The multiplicity of test was not adjusted because these comparisons were for the secondary objective.', 'groupDescription': 'Hypothesis testing was conducted with significant p-value level of under 0.05.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'CMH test stratified by H. pylori status was employed. Continuous correction was used.'}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified-safety analysis set (m-SAF) consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.'}, {'type': 'SECONDARY', 'title': 'Incidence of Any Gastric, and Duodenal Ulcers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib 100 mg tablet twice a day with meal for 2 weeks'}, {'id': 'OG001', 'title': 'Loxoprofen', 'description': 'Loxoprofen 60 mg tablet three times a day with meal for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet three times a day with meal for 2 weeks'}], 'classes': [{'title': 'Gastric ulcers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '2.7', 'groupId': 'OG002'}]}]}, {'title': 'Duodenal ulcers', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'The percentage of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.'}, {'type': 'SECONDARY', 'title': 'Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib 100 mg tablet twice a day with meal for 2 weeks'}, {'id': 'OG001', 'title': 'Loxoprofen', 'description': 'Loxoprofen 60 mg tablet three times a day with meal for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet three times a day with meal for 2 weeks'}], 'classes': [{'title': 'Gastroduodenal ulcers and/or erosions', 'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000'}, {'value': '53.9', 'groupId': 'OG001'}, {'value': '24.3', 'groupId': 'OG002'}]}]}, {'title': 'Gastric ulcers and/or erosions', 'categories': [{'measurements': [{'value': '35.1', 'groupId': 'OG000'}, {'value': '53.9', 'groupId': 'OG001'}, {'value': '24.3', 'groupId': 'OG002'}]}]}, {'title': 'Duodenal ulcers and/or erosions', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}, {'value': '5.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'The percentage of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment (The number of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth. An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.'}, {'type': 'SECONDARY', 'title': 'Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib 100 mg tablet twice a day with meal for 2 weeks'}, {'id': 'OG001', 'title': 'Loxoprofen', 'description': 'Loxoprofen 60 mg tablet three times a day with meal for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet three times a day with meal for 2 weeks'}], 'classes': [{'title': 'Score 0', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Score 1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Score 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Score 3', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Score 4', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Score 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Score 6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Score 7', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'Number of subjects for each gastroduodenal endoscopic score (according to Mucosal Grading Scale) after 2 weeks treatment (Score 0 = normal mucosa (no visible lesions); Score 1 = 1 to 10 petechiae; Score 2 = more than 10 petechiae; Score 3 = 1 to 5 erosions; Score 4 = 6 to 10 erosions; Score 5 = 11 to 25 erosions; Score 6 = more than 25 erosions; Score 7 = ulcer)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.'}, {'type': 'SECONDARY', 'title': 'Number of Gastroduodenal Ulcers in Each Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib 100 mg tablet twice a day with meal for 2 weeks'}, {'id': 'OG001', 'title': 'Loxoprofen', 'description': 'Loxoprofen 60 mg tablet three times a day with meal for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet three times a day with meal for 2 weeks'}], 'classes': [{'title': '0 ulcer', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}]}]}, {'title': '1 ulcer', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '2 ulcers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '3 ulcers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '4 ulcers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '5 ulcers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '6 ulcers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '7 ulcers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '8 ulcers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '9 ulcers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '10 or more ulcers', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'Number of subjects for each number of gastroduodenal endoscopic ulcers after 2 weeks treatment (An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.'}, {'type': 'SECONDARY', 'title': 'Number of Gastroduodenal Erosions in Each Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib 100 mg tablet twice a day with meal for 2 weeks'}, {'id': 'OG001', 'title': 'Loxoprofen', 'description': 'Loxoprofen 60 mg tablet three times a day with meal for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet three times a day with meal for 2 weeks'}], 'classes': [{'title': '0 erosion', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': '1 erosion', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': '2 erosions', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': '3 erosions', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': '4 erosions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '5 erosions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '6 erosions', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '7 erosions', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '8 erosions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '9 erosions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '10 or more erosions', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'Number of subjects for each number of gastroduodenal endoscopic erosions after 2 weeks treatment (An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.'}, {'type': 'SECONDARY', 'title': 'Incidence of Treatment-emergent, All-causality GI Body System Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib', 'description': 'Celecoxib 100 mg tablet twice a day with meal for 2 weeks'}, {'id': 'OG001', 'title': 'Loxoprofen', 'description': 'Loxoprofen 60 mg tablet three times a day with meal for 2 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo tablet three times a day with meal for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000'}, {'value': '47.4', 'groupId': 'OG001'}, {'value': '16.2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': 'The percentage of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment (The number of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment divided by participants multiplied by 100.)', 'unitOfMeasure': 'Percent', 'reportingStatus': 'POSTED', 'populationDescription': 'The m-SAF consisted of all randomized subjects who received at least one dose of the study drug, and underwent endoscopy at baseline and at the end/discontinuation of treatment, as well.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Celecoxib', 'description': 'Celecoxib 100 mg tablet twice a day with meal for 2 weeks'}, {'id': 'FG001', 'title': 'Loxoprofen', 'description': 'Loxoprofen 60 mg tablet three times a day with meal for 2 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo tablet three times a day with meal for 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'comment': 'One subject was randomized but did not receive study drug.', 'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were screened at 3 centers in Japan.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '189', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Celecoxib', 'description': 'Celecoxib 100 mg tablet twice a day with meal for 2 weeks'}, {'id': 'BG001', 'title': 'Loxoprofen', 'description': 'Loxoprofen 60 mg tablet three times a day with meal for 2 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo tablet three times a day with meal for 2 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '9.65', 'groupId': 'BG000'}, {'value': '57.8', 'spread': '9.38', 'groupId': 'BG001'}, {'value': '59.1', 'spread': '9.18', 'groupId': 'BG002'}, {'value': '57.5', 'spread': '9.45', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Helicobacter pylori (H. pylori) status', 'classes': [{'title': 'Positive', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}]}, {'title': 'Negative', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '108', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2009-10-13', 'resultsFirstSubmitDate': '2011-04-22', 'studyFirstSubmitQcDate': '2009-10-13', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-04-22', 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Gastroduodenal Ulcers', 'timeFrame': '2 weeks', 'description': 'The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.'}], 'secondaryOutcomes': [{'measure': 'Incidence of Any Gastric, and Duodenal Ulcers', 'timeFrame': '2 weeks', 'description': 'The percentage of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastric and duodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.'}, {'measure': 'Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions', 'timeFrame': '2 weeks', 'description': 'The percentage of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment (The number of subjects who had gastroduodenal, gastric, and duodenal endoscopic ulcers and/or erosions after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth. An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.'}, {'measure': 'Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)', 'timeFrame': '2 weeks', 'description': 'Number of subjects for each gastroduodenal endoscopic score (according to Mucosal Grading Scale) after 2 weeks treatment (Score 0 = normal mucosa (no visible lesions); Score 1 = 1 to 10 petechiae; Score 2 = more than 10 petechiae; Score 3 = 1 to 5 erosions; Score 4 = 6 to 10 erosions; Score 5 = 11 to 25 erosions; Score 6 = more than 25 erosions; Score 7 = ulcer)'}, {'measure': 'Number of Gastroduodenal Ulcers in Each Subject', 'timeFrame': '2 weeks', 'description': 'Number of subjects for each number of gastroduodenal endoscopic ulcers after 2 weeks treatment (An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.)'}, {'measure': 'Number of Gastroduodenal Erosions in Each Subject', 'timeFrame': '2 weeks', 'description': 'Number of subjects for each number of gastroduodenal endoscopic erosions after 2 weeks treatment (An erosion is defined as a lesion producing a definite break in the mucosa with equivocal depth.)'}, {'measure': 'Incidence of Treatment-emergent, All-causality GI Body System Adverse Events', 'timeFrame': '2 weeks', 'description': 'The percentage of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment (The number of subjects who had treatment-emergent, all-causality gastrointestinal body system adverse events after 2 weeks treatment divided by participants multiplied by 100.)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endoscopy'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '23216412', 'type': 'DERIVED', 'citation': 'Sakamoto C, Kawai T, Nakamura S, Sugioka T, Tabira J. Comparison of gastroduodenal ulcer incidence in healthy Japanese subjects taking celecoxib or loxoprofen evaluated by endoscopy: a placebo-controlled, double-blind 2-week study. Aliment Pharmacol Ther. 2013 Feb;37(3):346-54. doi: 10.1111/apt.12174. Epub 2012 Dec 10.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3191345&StudyName=Study%20Of%20Celecoxib%20In%20Healthy%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteers\n\nExclusion Criteria:\n\n* Endoscopic evidence of ulceration, erosion or active bleeding etc. in the esophagus, stomach, pylorus and/or duodenum prior to treatment endoscopy\n* A history of gastrointestinal ulcer\n* Any use of celecoxib, nonsteroidal anti-inflammatory drugs (including aspirin), anti-ulcer medication, antacids, systemic steroids or antibiotics within four weeks prior to the first dose of study medication'}, 'identificationModule': {'nctId': 'NCT00994461', 'briefTitle': 'Study Of Celecoxib In Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Double-Blind, Phase 4 Study To Compare The Effect Of Celecoxib 100 Mg BID, Loxoprofen 60 Mg TID And Placebo On The Gastroduodenal Mucosa In Healthy Subjects', 'orgStudyIdInfo': {'id': 'A3191345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Celecoxib', 'interventionNames': ['Drug: Celecoxib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Loxoprofen', 'interventionNames': ['Drug: Loxoprofen']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Celecoxib', 'type': 'DRUG', 'description': 'Celecoxib 100mg tablet twice a day with meal for 2 weeks', 'armGroupLabels': ['Celecoxib']}, {'name': 'Loxoprofen', 'type': 'DRUG', 'description': 'Loxoprofen 60mg tablet three times a day with meal for 2 weeks', 'armGroupLabels': ['Loxoprofen']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet three times a day with meal for 2 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Minato-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Pfizer's Upjohn has merged with Mylan to form Viatris Inc.", 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}