Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-28 @ 10:11 PM
Study NCT ID:
NCT00832650
Status:
TERMINATED
Last Update Posted:
2010-12-24
First Post:
2009-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C526675', 'term': 'fesoterodine'}, {'id': 'D000069464', 'term': 'Solifenacin Succinate'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, '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}, 'limitationsAndCaveats': {'description': 'Study was terminated due to futility based on interim analysis with 60 subjects. Although the results of statistical test for the primary endpoint was interpreted, the other endpoint results were interpreted based on statistical inference.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 7 days after last dose of study drug', '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': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily', 'otherNumAtRisk': 25, 'otherNumAffected': 22, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule', 'otherNumAtRisk': 12, 'otherNumAffected': 6, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily', 'otherNumAtRisk': 22, 'otherNumAffected': 15, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Dyschezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (v12.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Colonic Transit at 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule'}, {'id': 'OG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.98', 'spread': '0.770', 'groupId': 'OG000'}, {'value': '2.51', 'spread': '1.078', 'groupId': 'OG001'}, {'value': '1.91', 'spread': '0.515', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.051', 'ciLowerLimit': '-0.334', 'ciUpperLimit': '0.436', 'estimateComment': 'Least squares mean was calculated based on the ANCOVA model with treatment group as a fixed effect and baseline values, age and Body Mass Index (BMI) as covariates.', 'groupDescription': 'Null H10: μF8mg=μS10mg where μF8mg and μS10mg are means of GC24 for fesoterodine 8mg and solifenacin 10mg, respectively.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 13 (Day 12 24 hours post-meal)', 'description': 'Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC \\*1 + % TC \\*2 + % DC \\*3 + % RS \\*4 + % stool \\* 5 ) divided by 100.', 'unitOfMeasure': 'counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) included all randomized subjects. Imputation by overall mean for missing data.'}, {'type': 'SECONDARY', 'title': 'Proximal Colonic Emptying Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule'}, {'id': 'OG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '21.06', 'spread': '5.500', 'groupId': 'OG000'}, {'value': '14.79', 'spread': '6.239', 'groupId': 'OG001'}, {'value': '19.23', 'spread': '6.194', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12 to 14', 'description': 'Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT included all randomized subjects. Imputation by overall mean for missing data.'}, {'type': 'SECONDARY', 'title': 'Colonic Transit at 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule'}, {'id': 'OG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.55', 'spread': '0.934', 'groupId': 'OG000'}, {'value': '3.67', 'spread': '1.066', 'groupId': 'OG001'}, {'value': '3.14', 'spread': '0.765', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 14 (Day 12 48 hours post-meal)', 'description': 'Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC \\*1 + % TC \\*2 + % DC \\*3 + % RS \\*4 + % stool \\* 5 ) divided by 100.', 'unitOfMeasure': 'counts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT included all randomized subjects. Imputation by overall mean for missing data.'}, {'type': 'SECONDARY', 'title': 'Colonic Filling at 6 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule'}, {'id': 'OG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '7.84', 'spread': '16.286', 'groupId': 'OG000'}, {'value': '69.58', 'spread': '25.854', 'groupId': 'OG001'}, {'value': '24.06', 'spread': '23.696', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12', 'description': 'A surrogate marker of small bowel transit time.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT included all randomized subjects. Imputation by overall mean for missing data.'}, {'type': 'SECONDARY', 'title': 'Time to Gastric Emptying', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule'}, {'id': 'OG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '145.00', 'spread': '32.628', 'groupId': 'OG000'}, {'value': '112.92', 'spread': '21.998', 'groupId': 'OG001'}, {'value': '127.47', 'spread': '35.456', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12: 2 hours, 4 hours', 'description': 'Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT included all randomized subjects. Imputation by overall mean for missing data.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Stools Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule'}, {'id': 'OG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.93', 'spread': '0.397', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '0.422', 'groupId': 'OG001'}, {'value': '1.11', 'spread': '0.497', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 11 to 13', 'description': 'Number of stools passed on each notional day where each visit to the toilet counts as one stool (only) unless nothing is passed. Mean of 3 days.', 'unitOfMeasure': 'stools', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.'}, {'type': 'SECONDARY', 'title': 'Mean Score of Stool Consistency Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule'}, {'id': 'OG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.66', 'spread': '1.149', 'groupId': 'OG000'}, {'value': '3.29', 'spread': '1.112', 'groupId': 'OG001'}, {'value': '3.02', 'spread': '1.057', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 11 to 13', 'description': 'Calculated by averaging the values of the stool form given at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (hard lumps) to 7 (watery).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.'}, {'type': 'SECONDARY', 'title': 'Average Score of Ease of Passage During Defecation Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule'}, {'id': 'OG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '3.90', 'spread': '0.403', 'groupId': 'OG000'}, {'value': '3.97', 'spread': '0.096', 'groupId': 'OG001'}, {'value': '3.83', 'spread': '0.705', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 11 to 13', 'description': 'Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.'}, {'type': 'SECONDARY', 'title': 'Mean Proportion of Bowel Movements With Satisfaction Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule'}, {'id': 'OG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '0.250', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.324', 'groupId': 'OG001'}, {'value': '0.93', 'spread': '0.234', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 11 to 13', 'description': 'The number of stools with satisfaction of "Yes" divided by the total number of stools passed on each notional day. Mean of 3 days.', 'unitOfMeasure': 'mean proportion', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT, all randomized subjects with analyzeable data. Imputation by individual mean for missing data if at least one observation was observed in last 3 days.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule'}, {'id': 'FG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Fesoterodine', 'description': 'Fesoterodine 8 mg tablet once daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matched placebo tablet or capsule'}, {'id': 'BG002', 'title': 'Solifenacin', 'description': 'Solifenacin 10 mg capsule once daily'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'less than 18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': '18 to 25 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': '26 to 35 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}]}, {'title': '36 to 45 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'greater than 45 years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'whyStopped': 'Protocol A0221057 was terminated on December 25, 2009 for futility. There were no safety concerns related to this decision.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-02', 'studyFirstSubmitDate': '2009-01-28', 'resultsFirstSubmitDate': '2010-12-02', 'studyFirstSubmitQcDate': '2009-01-28', 'lastUpdatePostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-02', 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Colonic Transit at 24 Hours', 'timeFrame': 'Day 13 (Day 12 24 hours post-meal)', 'description': 'Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC \\*1 + % TC \\*2 + % DC \\*3 + % RS \\*4 + % stool \\* 5 ) divided by 100.'}], 'secondaryOutcomes': [{'measure': 'Proximal Colonic Emptying Time', 'timeFrame': 'Day 12 to 14', 'description': 'Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.'}, {'measure': 'Colonic Transit at 48 Hours', 'timeFrame': 'Day 14 (Day 12 48 hours post-meal)', 'description': 'Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC \\*1 + % TC \\*2 + % DC \\*3 + % RS \\*4 + % stool \\* 5 ) divided by 100.'}, {'measure': 'Colonic Filling at 6 Hours', 'timeFrame': 'Day 12', 'description': 'A surrogate marker of small bowel transit time.'}, {'measure': 'Time to Gastric Emptying', 'timeFrame': 'Day 12: 2 hours, 4 hours', 'description': 'Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.'}, {'measure': 'Mean Number of Stools Per Day', 'timeFrame': 'Day 11 to 13', 'description': 'Number of stools passed on each notional day where each visit to the toilet counts as one stool (only) unless nothing is passed. Mean of 3 days.'}, {'measure': 'Mean Score of Stool Consistency Per Day', 'timeFrame': 'Day 11 to 13', 'description': 'Calculated by averaging the values of the stool form given at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (hard lumps) to 7 (watery).'}, {'measure': 'Average Score of Ease of Passage During Defecation Per Day', 'timeFrame': 'Day 11 to 13', 'description': 'Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent).'}, {'measure': 'Mean Proportion of Bowel Movements With Satisfaction Per Day', 'timeFrame': 'Day 11 to 13', 'description': 'The number of stools with satisfaction of "Yes" divided by the total number of stools passed on each notional day. Mean of 3 days.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy; Fesoterodine; Solifenacin'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '23171069', 'type': 'DERIVED', 'citation': 'Bharucha AE, Isowa H, Hiro S, Guan Z. Differential effects of selective and non-selective muscarinic antagonists on gastrointestinal transit and bowel function in healthy women. Neurogastroenterol Motil. 2013 Jan;25(1):e35-43. doi: 10.1111/nmo.12043. Epub 2012 Nov 21.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221057&StudyName=Multiple%20Dose%20Study%20To%20Investigate%20The%20Effects%20Of%20Fesoterodine%20And%20Solifenacin%20On%20Gastrointestinal%20Transit', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy female subjects\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant findings at screening'}, 'identificationModule': {'nctId': 'NCT00832650', 'briefTitle': 'Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit', 'nctIdAliases': ['NCT00892034'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose Study To Investigate The Effects Of 8 Mg Fesoterodine SR Tablets And 10 Mg Solifenacin Tablet On Gastrointestinal Transit In Healthy Female Subjects.', 'orgStudyIdInfo': {'id': 'A0221057'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fesoterodine', 'description': 'Tablets', 'interventionNames': ['Drug: fesoterodine fumarate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Tablets', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Solifenacin', 'description': 'Tablets', 'interventionNames': ['Drug: solifenacin']}], 'interventions': [{'name': 'fesoterodine fumarate', 'type': 'DRUG', 'description': '8 mg OD for 14 days', 'armGroupLabels': ['Fesoterodine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'OD for 14 days', 'armGroupLabels': ['Placebo']}, {'name': 'solifenacin', 'type': 'DRUG', 'description': '10 mg OD for 14 days', 'armGroupLabels': ['Solifenacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}