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The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.
Evaluation of cognitive function
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4mg fesoterodine | Experimental |
| |
| fesoterodine 8mg | Experimental |
| |
| 1mg alprazolam | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4mg fesoterodine | Drug | 4mg tablet once daily for 6 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Computer Based Objective Cognition Testing (CogState) Detection Speed | Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance. | Baseline |
| Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 | Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance. | Baseline and Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| CogState Identification Speed | Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance. |
Not provided
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 | Overland Park | Kansas | 66211 | United States | ||
| Pfizer Investigational Site |
Not provided
| 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 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg | Fesoterodine 4 milligram (mg) tablet administered orally once daily (OD) for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period. |
| FG001 | Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo | Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period. |
| FG002 | Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg | Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period. |
| FG003 | Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg | Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention Period |
| ||||||||||||||||
| Washout Period (At Least 3 to 6 Days) |
| ||||||||||||||||
| Second Intervention Period |
| ||||||||||||||||
| Washout Period (At Least 3 to 6 Days) |
| ||||||||||||||||
| Third Intervention Period |
| ||||||||||||||||
| Washout Period (At Least 3 to 6 Days) |
| ||||||||||||||||
| Fourth Intervention Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | All participants randomized to any treatment (fesoterodine 4 mg tablet first, fesoterodine 8 mg tablet first, alprazolam 1 mg capsule first and placebo first). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Computer Based Objective Cognition Testing (CogState) Detection Speed | Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance. | The Per Protocol (PP) Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Log10 MS | Baseline |
|
Not provided
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fesoterodine 4 mg | Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA v13.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| C526675 | fesoterodine |
| D000525 | Alprazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 8mg fesoterodine |
| Drug |
4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days |
|
| alprazolam 1mg | Drug | 1mg tablet once on last day of treatment period at clinic |
|
| Placebo | Drug | Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic |
|
| Baseline |
| Change From Baseline in CogState Identification Speed on Day 6 | Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance. | Baseline and Day 6 |
| CogState One Card Learning | One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance. | Baseline |
| Change From Baseline in CogState One Card Learning on Day 6 | One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance. | Baseline and Day 6 |
| CogState Continuous Paired Associate Learning (CPAL) | CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance. | Baseline |
| Change From Baseline in CogState CPAL on Day 6 | CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance. | Baseline and Day 6 |
| CogState Groton Maze Learning Task (GMLT) | GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance. | Baseline |
| Change From Baseline in CogState Groton Maze Learning Task on Day 6 | GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance. | Baseline and Day 6 |
| Rey Auditory Verbal Learning Test (RAVLT) | RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance. | Baseline |
| Rey Auditory Verbal Learning Test (RAVLT) on Day 6 | RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance. | Baseline and Day 6 |
| Overland Park |
| Kansas |
| 66212 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
| OG001 | Fesoterodine 8 mg | Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods. |
| OG002 | Aplrazolam 1 mg | Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods. |
| OG003 | Placebo | Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods. |
|
|
| Primary | Change From Baseline in Computer Based Objective Cognition Testing (CogState) Detection Speed on Day 6 | Detection speed: a cognitive test which assessed psychomotor function. A playing card was presented face up in the center of the screen. As soon as this happened, the participant was to press the 'Yes' key. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses [measured in log10 milliseconds (MS)]. Lower scores meant a better performance. | The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Least Squares Mean | Standard Error | Log10 MS | Baseline and Day 6 |
|
|
|
|
| Secondary | CogState Identification Speed | Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance. | The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Log10 MS | Baseline |
|
|
|
| Secondary | Change From Baseline in CogState Identification Speed on Day 6 | Identification speed: a cognitive test which assessed visual attention. A playing card was presented face up in the center of the screen. As soon as this happened, the participant had to decide whether the card was red or not. The outcome measure was speed of performance; mean of the log10 transformed reaction time for correct responses (measured in log10 MS). Lower scores meant a better performance. | The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Least Squares Mean | Standard Error | Log10 MS | Baseline and Day 6 |
|
|
|
|
| Secondary | CogState One Card Learning | One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance. | The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Arcsine [(sqrt) proportion correct] | Baseline |
|
|
|
| Secondary | Change From Baseline in CogState One Card Learning on Day 6 | One card learning: a cognitive test which assessed visual learning. Participants were to remember which cards were previously shown in a task. The outcome measure was accuracy of performance; arcsine transformation of the square root (sqrt) of the proportion of correct responses. Higher scores meant a better performance. | The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Least Squares Mean | Standard Error | Arcsine [(sqrt) proportion correct] | Baseline and Day 6 |
|
|
|
|
| Secondary | CogState Continuous Paired Associate Learning (CPAL) | CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance. | The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Errors | Baseline |
|
|
|
| Secondary | Change From Baseline in CogState CPAL on Day 6 | CPAL: a cognitive test which assessed visual episodic learning. Participant was to learn and remember picture locations on the screen and was to tap the target on the central location to begin. As each picture was revealed, the participant was to remember where the picture was located and tap that location. The outcome measure was the number of errors made in correctly placing each of the 4 patterns in their location 4 times. Lower scores meant a better performance. | The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Least Squares Mean | Standard Error | Errors | Baseline and Day 6 |
|
|
|
|
| Secondary | CogState Groton Maze Learning Task (GMLT) | GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance. | The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Errors | Baseline |
|
|
|
| Secondary | Change From Baseline in CogState Groton Maze Learning Task on Day 6 | GMLT: a cognitive test which assessed executive function. Participant was shown a 10 x 10 grid of tiles on a computer touch screen. A 28-step pathway was hidden among 100 possible locations. The participant was instructed to move 1 step from the start location and then continue 1 tile at a time, toward the end to find the pathway. The outcome measure was total number of errors made in attempting to learn the same hidden pathway on 5 consecutive trials at a single session. Lower scores meant a better performance. | The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Least Squares Mean | Standard Error | Errors | Baseline and Day 6 |
|
|
|
|
| Secondary | Rey Auditory Verbal Learning Test (RAVLT) | RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance. | The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Mean | Standard Deviation | Words Recalled | Baseline |
|
|
|
| Secondary | Rey Auditory Verbal Learning Test (RAVLT) on Day 6 | RAVLT evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval. Assessment of RAVLT is between 10 to 15 minutes; Performance variable: the sum of the number of words recalled successfully on the delayed recall trial. Higher score meant a better performance. | The PP Analysis Set included all randomized participants who completed the study, received treatment in all 4 study periods until the end of treatment visit in the fourth study period and who were not serious protocol violators. 'N' (Number of participants analyzed) signifies participants evaluable for the outcome measure. | Posted | Least Squares Mean | Standard Error | Words Recalled | Baseline and Day 6 |
|
|
|
|
| 0 |
| 20 |
| 6 |
| 20 |
| EG001 | Fesoterodine 8 mg | Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods. | 0 | 19 | 11 | 19 |
| EG002 | Aplrazolam 1 mg | Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods. | 0 | 19 | 18 | 19 |
| EG003 | Placebo | Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods. | 0 | 20 | 7 | 20 |
| Visual impairment | Eye disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v13.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA v13.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Ataxia | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Urinary hesitation | Renal and urinary disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v13.0 | 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.
| D006571 | Heterocyclic Compounds |
ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates. |
| ANCOVA |
| 0.2459 |
| LS Mean Difference |
| -0.0203 |
| Standard Error of the Mean |
| 0.0173 |
| 2-Sided |
| 95 |
| -0.0551 |
| 0.0145 |
| No |
| Superiority or Other |
ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates. |
| ANCOVA |
| 0.4785 |
| LS Mean Difference |
| -0.0085 |
| Standard Error of the Mean |
| 0.0119 |
| 2-Sided |
| 95 |
| -0.0325 |
| 0.0154 |
| No |
| Superiority or Other |
ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates. |
| ANCOVA |
| 0.4308 |
| LS Mean Difference |
| 0.0209 |
| Standard Error of the Mean |
| 0.0263 |
| 2-Sided |
| 95 |
| -0.0320 |
| 0.0738 |
| No |
| Superiority or Other |
ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates. |
| ANCOVA |
| 0.1162 |
| LS Mean Difference |
| -19.9210 |
| Standard Error of the Mean |
| 12.4482 |
| 2-Sided |
| 95 |
| -44.9634 |
| 5.1215 |
| No |
| Superiority or Other |
ANCOVA was used to determine p-value for comparison of fesoterodine 4 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates. |
| ANCOVA |
| 0.7485 |
| LS Mean Difference |
| -1.6251 |
| Standard Error of the Mean |
| 5.0346 |
| 2-Sided |
| 95 |
| -11.7926 |
| 8.5425 |
| No |
| Superiority or Other |
ANCOVA was used to determine p-value for comparison of fesoterodine 8 mg vs placebo, with model terms: period and treatment as the fixed effect, participants as the random effect, and between and within participant baselines as the covariates. |
| ANCOVA |
| 0.9366 |
| LS Mean Difference |
| -0.0661 |
| Standard Error of the Mean |
| 0.8277 |
| 2-Sided |
| 95 |
| -1.7202 |
| 1.5880 |
| No |
| Superiority or Other |