Trial Outcomes & Findings for Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients (NCT NCT01042236)
NCT ID: NCT01042236
Last Updated: 2011-07-22
Results Overview
OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Baseline, Day 7 of each period
Results posted on
2011-07-22
Participant Flow
Participants randomized to receive sequenced dosing of Fesoterodine 4 milligrams (mg) (A), or Fesoterodine 8 milligrams (B), or Placebo matching study treatment (C). Each dosed for 7 days with a 7 day washout between dosing periods. Dosing sequenced as ABC, ACB, BAC, BCA, CAB, or CBA.
Participant milestones
| Measure |
Sequence ABC
Fesoterodine 4 mg (A) tablet administered by mouth (PO) once daily (OD) for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then placebo matching study treatment (C) with 7 day washout between dosing periods.
|
Sequence BCA
Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
|
Sequence CAB
Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
|
Sequence ACB
Fesoterodine 4 mg (A) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
|
Sequence BAC
Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then placebo matching study treatment (C) with 7 day washout between dosing periods.
|
Sequence CBA
Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
3
|
4
|
3
|
5
|
4
|
3
|
|
Treatment Period 1
COMPLETED
|
3
|
3
|
3
|
5
|
3
|
3
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Treatment Period 2
STARTED
|
3
|
3
|
3
|
5
|
3
|
3
|
|
Treatment Period 2
COMPLETED
|
3
|
3
|
3
|
5
|
3
|
3
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
3
|
3
|
3
|
5
|
3
|
3
|
|
Treatment Period 3
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence ABC
Fesoterodine 4 mg (A) tablet administered by mouth (PO) once daily (OD) for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then placebo matching study treatment (C) with 7 day washout between dosing periods.
|
Sequence BCA
Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
|
Sequence CAB
Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
|
Sequence ACB
Fesoterodine 4 mg (A) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
|
Sequence BAC
Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then placebo matching study treatment (C) with 7 day washout between dosing periods.
|
Sequence CBA
Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
1
|
0
|
0
|
1
|
0
|
|
Treatment Period 3
Adverse Event
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 3
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation Of The Ability Of Fesoterodine To Increase Urethral Pressure In Stress Urinary Incontinence Patients
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=22 Participants
Includes groups randomized to receive Fesoterodine (4mg) first, Fesoterodine (8mg) first, and Placebo first.
|
|---|---|
|
Age Continuous
|
47.9 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 7 of each periodPopulation: Per Protocol Analysis Set (PPAS): all randomized participants who completed the study, received treatment in all 3 study periods until end of treatment visit in the third study period, and had not violated any of the inclusion / exclusion criteria or deviated from the protocol in a way that could affect the outcome of the study.
OUP measured by urethral reflectometry calculated as the mean of all of the OUP measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Outcome measures
| Measure |
Fesoterodine (4 mg)
n=17 Participants
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=17 Participants
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=17 Participants
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7
Baseline
|
49.86 centimeter of water (cmH2O)
Standard Deviation 14.860
|
49.86 centimeter of water (cmH2O)
Standard Deviation 14.860
|
49.86 centimeter of water (cmH2O)
Standard Deviation 14.860
|
|
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7
Absolute value at Day 7
|
47.92 centimeter of water (cmH2O)
Standard Deviation 12.971
|
49.16 centimeter of water (cmH2O)
Standard Deviation 14.406
|
48.53 centimeter of water (cmH2O)
Standard Deviation 12.859
|
|
Change From Baseline in Opening Urethral Pressure (OUP) at Day 7
Mean change at Day 7
|
-1.94 centimeter of water (cmH2O)
Standard Deviation 4.767
|
-0.70 centimeter of water (cmH2O)
Standard Deviation 5.512
|
-1.34 centimeter of water (cmH2O)
Standard Deviation 5.178
|
SECONDARY outcome
Timeframe: Baseline, Day 7 of each periodPopulation: PPAS
Closing urethral pressure measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Outcome measures
| Measure |
Fesoterodine (4 mg)
n=17 Participants
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=17 Participants
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=17 Participants
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Change From Baseline in Closing Urethral Pressure at Day 7
Baseline
|
40.62 cmH20
Standard Deviation 14.379
|
40.62 cmH20
Standard Deviation 14.379
|
40.62 cmH20
Standard Deviation 14.379
|
|
Change From Baseline in Closing Urethral Pressure at Day 7
Absolute value at Day 7
|
37.84 cmH20
Standard Deviation 12.666
|
38.75 cmH20
Standard Deviation 13.172
|
38.66 cmH20
Standard Deviation 11.953
|
|
Change From Baseline in Closing Urethral Pressure at Day 7
Mean change at Day 7
|
-2.78 cmH20
Standard Deviation 5.571
|
-1.88 cmH20
Standard Deviation 5.475
|
-1.96 cmH20
Standard Deviation 5.915
|
SECONDARY outcome
Timeframe: Baseline, Day 7 of each periodPopulation: PPAS
Opening urethral elastance measured by urethral reflectometry calculated as the mean of each of the opening urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Outcome measures
| Measure |
Fesoterodine (4 mg)
n=17 Participants
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=17 Participants
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=17 Participants
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Change From Baseline in Opening Urethral Elastance at Day 7
Baseline
|
1.93 cmH2O/millimeter(mm)^2
Standard Deviation 0.551
|
1.93 cmH2O/millimeter(mm)^2
Standard Deviation 0.551
|
1.93 cmH2O/millimeter(mm)^2
Standard Deviation 0.551
|
|
Change From Baseline in Opening Urethral Elastance at Day 7
Absolue value at Day 7
|
1.66 cmH2O/millimeter(mm)^2
Standard Deviation 0.431
|
1.85 cmH2O/millimeter(mm)^2
Standard Deviation 0.684
|
1.83 cmH2O/millimeter(mm)^2
Standard Deviation 0.690
|
|
Change From Baseline in Opening Urethral Elastance at Day 7
Mean Change at Day 7
|
-0.27 cmH2O/millimeter(mm)^2
Standard Deviation 0.396
|
-0.08 cmH2O/millimeter(mm)^2
Standard Deviation 0.651
|
-0.10 cmH2O/millimeter(mm)^2
Standard Deviation 0.685
|
SECONDARY outcome
Timeframe: Baseline, Day 7 of each periodPopulation: PPAS
Closing urethral elastance measured by urethral reflectometry calculated as the mean of each of the closing urethral pressure measurements obtained in triplicate at each time point for each participant. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately.
Outcome measures
| Measure |
Fesoterodine (4 mg)
n=17 Participants
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=17 Participants
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=17 Participants
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Change From Baseline in Closing Urethral Elastance at Day 7
Baseline
|
1.85 cmH2O/mm^2
Standard Deviation 0.607
|
1.85 cmH2O/mm^2
Standard Deviation 0.607
|
1.85 cmH2O/mm^2
Standard Deviation 0.607
|
|
Change From Baseline in Closing Urethral Elastance at Day 7
Absolue value at Day 7
|
1.56 cmH2O/mm^2
Standard Deviation 0.347
|
1.74 cmH2O/mm^2
Standard Deviation 0.632
|
1.75 cmH2O/mm^2
Standard Deviation 0.647
|
|
Change From Baseline in Closing Urethral Elastance at Day 7
Mean change at Day 7
|
-0.28 cmH2O/mm^2
Standard Deviation 0.391
|
-0.10 cmH2O/mm^2
Standard Deviation 0.532
|
-0.09 cmH2O/mm^2
Standard Deviation 0.460
|
SECONDARY outcome
Timeframe: Baseline, Day 7 of each periodPopulation: PPAS
Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Outcome measures
| Measure |
Fesoterodine (4 mg)
n=17 Participants
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=17 Participants
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=17 Participants
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Incontinence Episode Frequency Per 24 Hours
Baseline
|
1.52 Episodes per 24 hours.
Standard Deviation 1.099
|
1.52 Episodes per 24 hours.
Standard Deviation 1.099
|
1.52 Episodes per 24 hours.
Standard Deviation 1.099
|
|
Incontinence Episode Frequency Per 24 Hours
Absolute value at Day 7
|
0.71 Episodes per 24 hours.
Standard Deviation 0.781
|
0.98 Episodes per 24 hours.
Standard Deviation 0.996
|
0.82 Episodes per 24 hours.
Standard Deviation 0.698
|
|
Incontinence Episode Frequency Per 24 Hours
Change at Day 7
|
-0.81 Episodes per 24 hours.
Standard Deviation 0.866
|
-0.54 Episodes per 24 hours.
Standard Deviation 1.114
|
-0.70 Episodes per 24 hours.
Standard Deviation 0.866
|
SECONDARY outcome
Timeframe: Baseline, Day 7 of each periodPopulation: PPAS; (n)=only participants with \>0 episodes at baseline were to be included in the analysis.
Incontinence Episode Frequency (IEF) calculated as the average daily total incontinence episodes (stress or urgency) that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Outcome measures
| Measure |
Fesoterodine (4 mg)
n=17 Participants
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=17 Participants
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=17 Participants
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours
|
-66.67 Percent
Interval -100.0 to 66.7
|
-55.56 Percent
Interval -100.0 to 266.7
|
-60.00 Percent
Interval -100.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7 of each periodPopulation: PPAS
Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Outcome measures
| Measure |
Fesoterodine (4 mg)
n=17 Participants
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=17 Participants
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=17 Participants
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Stress Incontinence Episode Frequency Per 24 Hours
Baseline
|
1.44 Episodes per 24 hours.
Standard Deviation 1.052
|
1.44 Episodes per 24 hours.
Standard Deviation 1.052
|
1.44 Episodes per 24 hours.
Standard Deviation 1.052
|
|
Stress Incontinence Episode Frequency Per 24 Hours
Absolute value at Day 7
|
0.69 Episodes per 24 hours.
Standard Deviation 0.759
|
0.98 Episodes per 24 hours.
Standard Deviation 0.996
|
0.82 Episodes per 24 hours.
Standard Deviation 0.698
|
|
Stress Incontinence Episode Frequency Per 24 Hours
Change at Day 7
|
-0.75 Episodes per 24 hours.
Standard Deviation 0.812
|
-0.46 Episodes per 24 hours.
Standard Deviation 1.043
|
-0.62 Episodes per 24 hours.
Standard Deviation 0.897
|
SECONDARY outcome
Timeframe: Baseline, Day 7 of each periodPopulation: PPAS; (n)=only participants with \>0 episodes at baseline were to be included in the analysis.
Stress Incontinence Component of the daily IEF calculated as the average daily number of stress leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Outcome measures
| Measure |
Fesoterodine (4 mg)
n=17 Participants
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=17 Participants
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=17 Participants
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours
|
-66.67 Percent
Interval -100.0 to 100.0
|
-55.56 Percent
Interval -100.0 to 266.7
|
-60.00 Percent
Interval -100.0 to 200.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7 of each periodPopulation: PPAS
Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Outcome measures
| Measure |
Fesoterodine (4 mg)
n=17 Participants
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=17 Participants
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=17 Participants
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Urgency Urinary Incontinence Episode Frequency Per 24 Hours
Baseline
|
0.08 Episodes per 24 hours.
Standard Deviation 0.251
|
0.08 Episodes per 24 hours.
Standard Deviation 0.251
|
0.08 Episodes per 24 hours.
Standard Deviation 0.251
|
|
Urgency Urinary Incontinence Episode Frequency Per 24 Hours
Absolute value at Day 7
|
0.02 Episodes per 24 hours.
Standard Deviation 0.081
|
0.00 Episodes per 24 hours.
Standard Deviation 0.000
|
0.00 Episodes per 24 hours.
Standard Deviation 0.000
|
|
Urgency Urinary Incontinence Episode Frequency Per 24 Hours
Change at Day 7
|
-0.06 Episodes per 24 hours.
Standard Deviation 0.243
|
-0.08 Episodes per 24 hours.
Standard Deviation 0.251
|
-0.08 Episodes per 24 hours.
Standard Deviation 0.251
|
SECONDARY outcome
Timeframe: Baseline, Day 7 of each periodPopulation: PPAS; (n)=only subjects with \>0 participants at baseline were to be included in the analysis.
Urgency Urinary Incontinence Component of the daily IEF calculated as the average daily number of urgency leakage episodes that occurred during the 3 days prior to randomization and the end of each treatment period. Day 7 mean for each treatment period was calculated as the mean daily episode frequency based on the diary completed in the final three days of each treatment period.
Outcome measures
| Measure |
Fesoterodine (4 mg)
n=2 Participants
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=2 Participants
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=2 Participants
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours
|
-50.00 Percent
Interval -100.0 to 0.0
|
-100.00 Percent
Interval -100.0 to -100.0
|
-100.00 Percent
Interval -100.0 to -100.0
|
SECONDARY outcome
Timeframe: Baseline, Day 7 of each periodPopulation: Full Analysis Set (FAS): all randomized subjects who had taken at least one dose of study treatment; (n)=number of participants with observations (non-missing concentrations)
Plasma 5-HMT concentration data pre and post reflectometry following multiple doses of fesoterodine 4 mg OD and fesoterodine 8 mg OD. Day 7 mean for each treatment period was calculated as the mean of the three measurements taken post-dose on Day 7 of each treatment period separately. Summary statistics were to be calculated by setting concentration values below the lower limit of quantification (LLQ = 0.02 ng/mL) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) = 0.
Outcome measures
| Measure |
Fesoterodine (4 mg)
n=18 Participants
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=18 Participants
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration
Pre-Reflectometry (n=18, 18)
|
2.303 nanogram/milliliter (ng/mL)
Standard Deviation 1.2798
|
4.902 nanogram/milliliter (ng/mL)
Standard Deviation 2.1554
|
—
|
|
Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration
Post-Reflectometry (n=18, 17)
|
2.185 nanogram/milliliter (ng/mL)
Standard Deviation 1.1970
|
4.971 nanogram/milliliter (ng/mL)
Standard Deviation 1.8195
|
—
|
Adverse Events
Fesoterodine (4 mg)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Fesoterodine (8 mg)
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fesoterodine (4 mg)
n=20 participants at risk
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=22 participants at risk
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=20 participants at risk
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Fesoterodine (4 mg)
n=20 participants at risk
Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Fesoterodine (8 mg)
n=22 participants at risk
Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
|
Placebo
n=20 participants at risk
Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
|
|---|---|---|---|
|
Eye disorders
Dry Eye
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Vitreous disorder
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
2/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
2/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
15.0%
3/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
54.5%
12/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.0%
3/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Malaise
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
20.0%
4/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
22.7%
5/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.0%
2/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.0%
1/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
4.5%
1/22 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/20 • Baseline (Period 1 / Day 1) up 28 days after last dose of study treatment
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 participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER