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Protocol A0221057 was terminated on December 25, 2009 for futility. There were no safety concerns related to this decision.
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To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fesoterodine | Experimental | Tablets |
|
| Placebo | Placebo Comparator | Tablets |
|
| Solifenacin | Active Comparator | Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fesoterodine fumarate | Drug | 8 mg OD for 14 days |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Colonic Transit at 24 Hours | 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. | Day 13 (Day 12 24 hours post-meal) |
| Measure | Description | Time Frame |
|---|---|---|
| Proximal Colonic Emptying Time | Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. | Day 12 to 14 |
| Colonic Transit at 48 Hours | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23171069 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fesoterodine | Fesoterodine 8 mg tablet once daily |
| FG001 | Placebo | Matched placebo tablet or capsule |
| FG002 | Solifenacin | Solifenacin 10 mg capsule once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fesoterodine | Fesoterodine 8 mg tablet once daily |
| BG001 | Placebo | Matched placebo tablet or capsule |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Colonic Transit at 24 Hours | 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. | Intent to treat (ITT) included all randomized subjects. Imputation by overall mean for missing data. | Posted | Mean | Standard Deviation | counts | Day 13 (Day 12 24 hours post-meal) |
|
Up to 7 days after last dose of study drug
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fesoterodine | Fesoterodine 8 mg tablet once daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA (v12.1) | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| Drug |
OD for 14 days |
|
| solifenacin | Drug | 10 mg OD for 14 days |
|
| Day 14 (Day 12 48 hours post-meal) |
| Colonic Filling at 6 Hours | A surrogate marker of small bowel transit time. | Day 12 |
| Time to Gastric Emptying | Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. | Day 12: 2 hours, 4 hours |
| Mean Number of Stools Per Day | 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. | Day 11 to 13 |
| Mean Score of Stool Consistency Per Day | 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). | Day 11 to 13 |
| Average Score of Ease of Passage During Defecation Per Day | 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). | Day 11 to 13 |
| Mean Proportion of Bowel Movements With Satisfaction Per Day | The number of stools with satisfaction of "Yes" divided by the total number of stools passed on each notional day. Mean of 3 days. | Day 11 to 13 |
| BG002 |
| Solifenacin |
Solifenacin 10 mg capsule once daily |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Matched placebo tablet or capsule |
| OG002 | Solifenacin | Solifenacin 10 mg capsule once daily |
|
|
|
| Secondary | Proximal Colonic Emptying Time | Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. | ITT included all randomized subjects. Imputation by overall mean for missing data. | Posted | Mean | Standard Deviation | hours | Day 12 to 14 |
|
|
|
| Secondary | Colonic Transit at 48 Hours | 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. | ITT included all randomized subjects. Imputation by overall mean for missing data. | Posted | Mean | Standard Deviation | counts | Day 14 (Day 12 48 hours post-meal) |
|
|
|
| Secondary | Colonic Filling at 6 Hours | A surrogate marker of small bowel transit time. | ITT included all randomized subjects. Imputation by overall mean for missing data. | Posted | Mean | Standard Deviation | percentage | Day 12 |
|
|
|
| Secondary | Time to Gastric Emptying | Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. | ITT included all randomized subjects. Imputation by overall mean for missing data. | Posted | Mean | Standard Deviation | minutes | Day 12: 2 hours, 4 hours |
|
|
|
| Secondary | Mean Number of Stools Per Day | 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. | 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. | Posted | Mean | Standard Deviation | stools | Day 11 to 13 |
|
|
|
| Secondary | Mean Score of Stool Consistency Per Day | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 11 to 13 |
|
|
|
| Secondary | Average Score of Ease of Passage During Defecation Per Day | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 11 to 13 |
|
|
|
| Secondary | Mean Proportion of Bowel Movements With Satisfaction Per Day | The number of stools with satisfaction of "Yes" divided by the total number of stools passed on each notional day. Mean of 3 days. | 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. | Posted | Mean | Standard Deviation | mean proportion | Day 11 to 13 |
|
|
|
| 0 |
| 25 |
| 22 |
| 25 |
| EG001 | Placebo | Matched placebo tablet or capsule | 0 | 12 | 6 | 12 |
| EG002 | Solifenacin | Solifenacin 10 mg capsule once daily | 0 | 22 | 15 | 22 |
| Vision blurred | Eye disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Dyschezia | Gastrointestinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (v12.1) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (v12.1) | Non-systematic Assessment |
|
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.
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |