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The hypothesis under evaluation is that fesotorodine may provide clinical benefit in the treatment of the condition of stress urinary incontinence
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fesoterodine | Drug | Fesoterodine 4 mg and 8 mg and placebo - each dosed for 7 days with 7 day washout between dosing periods |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | 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. | Baseline, Day 7 of each period |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Closing Urethral Pressure at Day 7 | 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. |
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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 |
|---|---|---|---|---|---|---|
| Glostrup Hospital | Glostrup Municipality | 2600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24258099 | Derived | Klarskov N, Darekar A, Scholfield D, Whelan L, Lose G. Effect of fesoterodine on urethral closure function in women with stress urinary incontinence assessed by urethral pressure reflectometry. Int Urogynecol J. 2014 Jun;25(6):755-60. doi: 10.1007/s00192-013-2269-6. Epub 2013 Nov 21. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Treatment Period 2 |
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| Treatment Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes groups randomized to receive Fesoterodine (4mg) first, Fesoterodine (8mg) 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 | Change From Baseline in Opening Urethral Pressure (OUP) at Day 7 | 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. | 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. | Posted | Mean | Standard Deviation | centimeter of water (cmH2O) | Baseline, Day 7 of each period |
|
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.
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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 (4 mg) | Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | MEdDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Eye | Eye disorders | MEdDRA 13.0 | Systematic Assessment |
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| 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 |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
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| Baseline, Day 7 of each period |
| Change From Baseline in Opening Urethral Elastance at Day 7 | 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. | Baseline, Day 7 of each period |
| Change From Baseline in Closing Urethral Elastance at Day 7 | 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. | Baseline, Day 7 of each period |
| Incontinence Episode Frequency Per 24 Hours | 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. | Baseline, Day 7 of each period |
| Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours | 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. | Baseline, Day 7 of each period |
| Stress Incontinence Episode Frequency Per 24 Hours | 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. | Baseline, Day 7 of each period |
| Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours | 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. | Baseline, Day 7 of each period |
| Urgency Urinary Incontinence Episode Frequency Per 24 Hours | 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. | Baseline, Day 7 of each period |
| Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours | 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. | Baseline, Day 7 of each period |
| Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration | 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. | Baseline, Day 7 of each period |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Fesoterodine (8 mg) | Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period. |
| OG002 | Placebo | Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period. |
|
|
|
| Secondary | Change From Baseline in Closing Urethral Pressure at Day 7 | 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. | PPAS | Posted | Mean | Standard Deviation | cmH20 | Baseline, Day 7 of each period |
|
|
|
|
| Secondary | Change From Baseline in Opening Urethral Elastance at Day 7 | 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. | PPAS | Posted | Mean | Standard Deviation | cmH2O/millimeter(mm)^2 | Baseline, Day 7 of each period |
|
|
|
|
| Secondary | Change From Baseline in Closing Urethral Elastance at Day 7 | 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. | PPAS | Posted | Mean | Standard Deviation | cmH2O/mm^2 | Baseline, Day 7 of each period |
|
|
|
|
| Secondary | Incontinence Episode Frequency Per 24 Hours | 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. | PPAS | Posted | Mean | Standard Deviation | Episodes per 24 hours. | Baseline, Day 7 of each period |
|
|
|
| Secondary | Percent Change From Baseline in Incontinence Episode Frequency Per 24 Hours | 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. | PPAS; (n)=only participants with >0 episodes at baseline were to be included in the analysis. | Posted | Median | Full Range | Percent | Baseline, Day 7 of each period |
|
|
|
| Secondary | Stress Incontinence Episode Frequency Per 24 Hours | 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. | PPAS | Posted | Mean | Standard Deviation | Episodes per 24 hours. | Baseline, Day 7 of each period |
|
|
|
| Secondary | Percent Change From Baseline in Stress Incontinence Episode Frequency Per 24 Hours | 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. | PPAS; (n)=only participants with >0 episodes at baseline were to be included in the analysis. | Posted | Median | Full Range | Percent | Baseline, Day 7 of each period |
|
|
|
| Secondary | Urgency Urinary Incontinence Episode Frequency Per 24 Hours | 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. | PPAS | Posted | Mean | Standard Deviation | Episodes per 24 hours. | Baseline, Day 7 of each period |
|
|
|
| Secondary | Percent Change From Baseline in Urgency Urinary Incontinence Episode Frequency Per 24 Hours | 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. | PPAS; (n)=only subjects with >0 participants at baseline were to be included in the analysis. | Posted | Median | Full Range | Percent | Baseline, Day 7 of each period |
|
|
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| Secondary | Plasma 5-hydroxymethyl Tolterodine (5- HMT) Concentration | 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. | 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) | Posted | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | Baseline, Day 7 of each period |
|
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|
| 0 |
| 20 |
| 8 |
| 20 |
| EG001 | Fesoterodine (8 mg) | Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period. | 1 | 22 | 17 | 22 |
| EG002 | Placebo | Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period. | 0 | 20 | 8 | 20 |
| Vitreous disorder | Eye disorders | MEdDRA 13.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MEdDRA 13.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MEdDRA 13.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MEdDRA 13.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MEdDRA 13.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MEdDRA 13.0 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MEdDRA 13.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEdDRA 13.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MEdDRA 13.0 | Systematic Assessment |
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| Malaise | General disorders | MEdDRA 13.0 | Systematic Assessment |
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| Pyrexia | General disorders | MEdDRA 13.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MEdDRA 13.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MEdDRA 13.0 | Systematic Assessment |
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| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MEdDRA 13.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MEdDRA 13.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MEdDRA 13.0 | Systematic Assessment |
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| Dysmenorrhea | Reproductive system and breast disorders | MEdDRA 13.0 | Systematic Assessment |
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| Vulvovaginal discomfort | Reproductive system and breast disorders | MEdDRA 13.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEdDRA 13.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MEdDRA 13.0 | 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.
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Mean change at Day 7 |
|
| Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect. | ANCOVA | 0.4167 | A treatment by period interaction term (fixed effect) was included if significant at 10% significance level. | Mean Difference (Final Values) | -0.78 | Standard Error of the Mean | 0.94 | 2-Sided | 95 | -2.71 | 1.15 | No | Superiority or Other |
|
| Mean Change at Day 7 |
|
| Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect. | ANCOVA | 0.1881 | A treatment by period interaction term (fixed effect) was included if significant at 10% significance level. | Mean Difference (Final Values) | -0.17 | Standard Error of the Mean | 0.12 | 2-Sided | 95 | -0.42 | 0.09 | No | Superiority or Other |
|
| Mean change at Day 7 |
|
| Change from baseline (prior to Period 1) at the end of the treatment period was analyzed using an analysis of covariance (ANCOVA) model, with fixed effect terms for sequence, period and treatment, using baseline (prior to Period 1) as a covariate, and participant within sequence as a random effect. | ANCOVA | 0.1271 | A treatment by period interaction term (fixed effect) was included if significant at 10% significance level. | Mean Difference (Final Values) | -0.19 | Standard Error of the Mean | 0.12 | 2-Sided | 95 | -0.43 | 0.06 | No | Superiority or Other |
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| Change at Day 7 |
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| Change at Day 7 |
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| Change at Day 7 |
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