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| ID | Type | Description | Link |
|---|---|---|---|
| OXY-KOR-4001 |
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The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose escalation in participants with overactive bladder.
This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time) Phase 4 study of oxybutynin chloride OROS in participants with overactive bladder. The total study duration will be 12 weeks and will include following visits: Screening (Week -2), Baseline, Week 2, 4, 6 and 12. Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up to Week 12. Maximum allowed dose will be 30 mg per day. Efficacy will primarily be evaluated by assessment of goal achievement (percentage of participants who show a score 4 or 5 in the Likert scale for treatment goal) at Week 12. Participants' safety will also be monitored at each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutynin Chloride OROS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin chloride OROS | Drug | Participants will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will be continued up to Week 12. Maximum allowed dose will be 30 mg per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Treatment Goal | Goal achievement was measured by using the 6-point Likert scale (0=not achieved at all and 5=completely achieved). Achievement of treatment goal was defined by a score of 4 or 5 in the Likert scale. Percentage of participants who achieved their treatment goal defined at Baseline (for a maximum of 3 items among the 10 items including incontinence, urinary urgency, frequent urination, nocturnal frequent urination, tenesmus, general health, life habit, activity, pain/pressure pain, and sexual function) was reported. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12 | Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urinary urgency (strong micturition desire indicated) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd. Clinical Trial | Janssen Korea, Ltd. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxybutynin Chloride OROS | Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Intent-to-treat (ITT) population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available.
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxybutynin Chloride OROS | Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day. |
| 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 | Percentage of Participants Who Achieved Treatment Goal | Goal achievement was measured by using the 6-point Likert scale (0=not achieved at all and 5=completely achieved). Achievement of treatment goal was defined by a score of 4 or 5 in the Likert scale. Percentage of participants who achieved their treatment goal defined at Baseline (for a maximum of 3 items among the 10 items including incontinence, urinary urgency, frequent urination, nocturnal frequent urination, tenesmus, general health, life habit, activity, pain/pressure pain, and sexual function) was reported. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Missing data at Week 12 were imputed using last observation carried forward (LOCF). | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 12 |
|
Baseline up to Week 12
Safety population included all participants who received the study drug at least once and had safety data available after starting the study treatment (N=320).
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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 | Oxybutynin Chloride OROS | Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Associate | Medical Affairs, Janssen Korea | +82-2-2094-4935 |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Baseline and Week 12 |
| Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12 | Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by daytime frequent urination (frequent urination was required more than the frequency desired during daytime) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported. | Baseline and Week 12 |
| Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12 | Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by nighttime frequent urination (waking up from sleep in order to void urine at nighttime [period from time of going to bed to time planned to wake up in the morning]) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported. | Baseline and Week 12 |
| Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12 | Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urge urinary incontinence (involuntary voiding or urinary leakage due to sudden micturition desire, not by sneezing, coughing or laughing) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported. | Baseline and Week 12 |
| Patient's Perception of Symptom Improvement (PPSI) Score for Overactive Bladder | Participant's perception about decrease in the most bothering symptom of overactive bladder (defined at Baseline) was evaluated by using visual analogue scale (VAS) at Week 12. The total score range was 0 to 100 where 0=symptom disappeared and 100=symptom unchanged or worsened compared to Baseline. | Week 12 |
| Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire | The PPTB was used to assess participant's perception about treatment benefit and satisfaction of the study drug. Regarding benefit, participants indicated whether they had any benefit obtained from the treatment. If yes, then the participants indicated whether it was weak benefit or strong benefit. Regarding satisfaction, participants indicated whether they were satisfied with the treatment. If yes, then they indicated if the treatment was slightly satisfactory or very satisfactory. If no, then they indicated if the treatment was slightly unsatisfactory or very unsatisfactory. | Week 2, 4, 6 and 12 |
| Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire | Participant's perception about bladder condition was evaluated by using self administered PPBC questionnaire. Participants answered "Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale: 1= not problematic at all, 2=mild problem, 3=more or less a mild problem, 4=moderate problem, 5=severe problem and 6=very severe problem. | Baseline and Week 12 |
| Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12 | The OAB-q was used to evaluate influence of overactive bladder symptom on health-related quality of life (HRQL). It consisted of 2 parts: Symptom bother (6 items) evaluating how much symptoms related to overactive bladder were bothering in the last 4 weeks and HRQL (13 items) evaluating how general symptoms related to the bladder influenced life in the last 4 weeks. Each item was rated on 6-point Likert scale: 1 (not at all) to 6 (a very great deal). Total score range: 6 to 36 for symptom bother and 13 to 78 for HRQL. Transformed score calculated as ([Actual total raw score - lowest possible value of raw score]/range)*100 for symptom bother where higher score indicates greater symptom bother and as ([Highest possible raw score-Actual total raw score]/Raw score range)*100 for HRQL where higher scores indicate better HRQL. Transformed score range: 0-100 for both, symptom bother and HRQL. | Baseline, Week 6, 12 or early discontinuation (ED) |
| Mean Voiding Frequency | Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle. | Baseline, Week 6, 12 or ED |
| Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12 | Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle. Percent change was calculated as (change value/Baseline value)*100. | Baseline, Week 6, 12 or ED |
| Frequency of Urinary Urgency and Urinary Incontinence | Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of urinary incontinence (UI) for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3. | Baseline, Week 6, 12 or ED |
| Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12 | Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of UI for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3. Percent change was calculated as (change value/Baseline value)*100. | Baseline, Week 6, 12 or ED |
| Mean Severity of Urinary Urgency at Urination | Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency, 2=light urinary urgency, 3=moderate urinary urgency, 4=severe urinary urgency and 5=urge urinary incontinence). Mean severity of urinary urgency at urination was calculated as sum of all degrees of urinary urgency measured divided by the voiding frequency. | Baseline, Week 6, 12 or ED |
| Visual Analogue Scale (VAS) Score for Dry Mouth | Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they have experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth). | Baseline, Week 6, 12 or ED |
| Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12 | Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth). Percent change was calculated as (change value/Baseline value)*100. | Baseline, Week 6, 12 or ED |
| Protocol Violation |
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| Other |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
|
Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
|
|
| Secondary | Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12 | Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urinary urgency (strong micturition desire indicated) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Participants | Baseline and Week 12 |
|
|
|
| Secondary | Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12 | Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by daytime frequent urination (frequent urination was required more than the frequency desired during daytime) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Participants | Baseline and Week 12 |
|
|
|
| Secondary | Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12 | Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by nighttime frequent urination (waking up from sleep in order to void urine at nighttime [period from time of going to bed to time planned to wake up in the morning]) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Participants | Baseline and Week 12 |
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| Secondary | Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12 | Participants assessed their bothering for overactive bladder symptom by completing POSQ rated on a 5-point scale: how much they were bothered by urge urinary incontinence (involuntary voiding or urinary leakage due to sudden micturition desire, not by sneezing, coughing or laughing) in the past two weeks. The responses were indicated as: 1 (not bothered at all), 2 (slightly bothered), 3 (average), 4 (strongly bothered) and 5 (very strongly bothered). Number of participants with change from Baseline in the response to this question at Week 12 was reported. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Participants | Baseline and Week 12 |
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| Secondary | Patient's Perception of Symptom Improvement (PPSI) Score for Overactive Bladder | Participant's perception about decrease in the most bothering symptom of overactive bladder (defined at Baseline) was evaluated by using visual analogue scale (VAS) at Week 12. The total score range was 0 to 100 where 0=symptom disappeared and 100=symptom unchanged or worsened compared to Baseline. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | Units on a scale | Week 12 |
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| Secondary | Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire | The PPTB was used to assess participant's perception about treatment benefit and satisfaction of the study drug. Regarding benefit, participants indicated whether they had any benefit obtained from the treatment. If yes, then the participants indicated whether it was weak benefit or strong benefit. Regarding satisfaction, participants indicated whether they were satisfied with the treatment. If yes, then they indicated if the treatment was slightly satisfactory or very satisfactory. If no, then they indicated if the treatment was slightly unsatisfactory or very unsatisfactory. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories. | Posted | Number | Participants | Week 2, 4, 6 and 12 |
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| Secondary | Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire | Participant's perception about bladder condition was evaluated by using self administered PPBC questionnaire. Participants answered "Which of the following statements describes your bladder condition best at the moment?" on a 6-point scale: 1= not problematic at all, 2=mild problem, 3=more or less a mild problem, 4=moderate problem, 5=severe problem and 6=very severe problem. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point. | Posted | Number | Participants | Baseline and Week 12 |
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| Secondary | Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12 | The OAB-q was used to evaluate influence of overactive bladder symptom on health-related quality of life (HRQL). It consisted of 2 parts: Symptom bother (6 items) evaluating how much symptoms related to overactive bladder were bothering in the last 4 weeks and HRQL (13 items) evaluating how general symptoms related to the bladder influenced life in the last 4 weeks. Each item was rated on 6-point Likert scale: 1 (not at all) to 6 (a very great deal). Total score range: 6 to 36 for symptom bother and 13 to 78 for HRQL. Transformed score calculated as ([Actual total raw score - lowest possible value of raw score]/range)*100 for symptom bother where higher score indicates greater symptom bother and as ([Highest possible raw score-Actual total raw score]/Raw score range)*100 for HRQL where higher scores indicate better HRQL. Transformed score range: 0-100 for both, symptom bother and HRQL. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories at given time point. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 6, 12 or early discontinuation (ED) |
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| Secondary | Mean Voiding Frequency | Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories. | Posted | Mean | Standard Deviation | Urinations per day | Baseline, Week 6, 12 or ED |
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| Secondary | Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12 | Mean voiding frequency for 24 hours was calculated as sum of total voiding frequency divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean daytime voiding frequency for 24 hours was calculated as sum of total daytime voiding frequency divided by the number of days when micturition chart was completed. Mean nighttime voiding frequency for 24 hours was calculated as sum of total nighttime voiding frequency divided by the number of days when micturition chart was completed. Nighttime voiding was defined as voiding during the sleep cycle. Percent change was calculated as (change value/Baseline value)*100. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 6, 12 or ED |
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| Secondary | Frequency of Urinary Urgency and Urinary Incontinence | Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of urinary incontinence (UI) for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories. | Posted | Mean | Standard Deviation | Episodes per day | Baseline, Week 6, 12 or ED |
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| Secondary | Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12 | Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency and 5=urge urinary incontinence). Total frequency of UI for 24 hours was calculated as sum of total frequency of incontinence divided by the number of days when micturition chart was completed. Participants completed micturition chart for 3 days at Baseline, Week 6 and 12/ED. Mean frequency of urinary urgency for 24 hours was calculated as sum of total frequency of urinary urgency divided by the number of days when micturition chart was completed. Urinary urgency was defined as voiding with urinary sensation scale score greater than or equal to 3. Percent change was calculated as (change value/Baseline value)*100. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here, 'n' specifies those participants who were evaluable for specific categories. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 6, 12 or ED |
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| Secondary | Mean Severity of Urinary Urgency at Urination | Urinary urgency means sudden and strong urge to urinate. It was rated by participant on 5-point scale (1=no urinary urgency, 2=light urinary urgency, 3=moderate urinary urgency, 4=severe urinary urgency and 5=urge urinary incontinence). Mean severity of urinary urgency at urination was calculated as sum of all degrees of urinary urgency measured divided by the voiding frequency. | Data was reported in individual participant listings as planned, but not statistically summarized for analysis. | Posted | Baseline, Week 6, 12 or ED |
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| Secondary | Visual Analogue Scale (VAS) Score for Dry Mouth | Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they have experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth). | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 6, 12 or ED |
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| Secondary | Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12 | Severity of dry mouth was evaluated in participants by using VAS: how much dry mouth they experienced in the past one week. The total score range was 0 (no dry mouth) to 100 (unimaginably most severe dry mouth). Percent change was calculated as (change value/Baseline value)*100. | ITT population included all participants who received study drug at least once and had data for efficacy evaluation (goal achievement in treatment) available. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure and 'n' specifies those participants who were evaluable for specific categories. | Posted | Mean | Standard Deviation | Percent change | Baseline, Week 6, 12 or ED |
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|
|
| 3 |
| 320 |
| 289 |
| 320 |
| Ventricular hypertrophy | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Epigastric discomfort | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Urine flow decreased | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Bladder pain | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Urinary hesitation | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Hypertonic bladder | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Pyuria | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Urethral pain | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Face oedema | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Xerophthalmia | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Blepharospasm | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Cardiovascular disorder | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
Not provided
Not provided
| 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 |
| Title | Measurements |
|---|---|
|
| Baseline: Not bothered, Week 12: Strongly |
|
| Baseline: Not bothered, Week 12: Very strongly |
|
| Baseline: Slightly, Week 12: Not bothered |
|
| Baseline: Slightly, Week 12: Slightly |
|
| Baseline: Slightly, Week 12: Average |
|
| Baseline: Slightly, Week 12: Strongly |
|
| Baseline: Slightly, Week 12: Very strongly |
|
| Baseline: Average, Week 12: Not bothered |
|
| Baseline: Average, Week 12: Slightly |
|
| Baseline: Average, Week 12: Average |
|
| Baseline: Average, Week 12: Strongly |
|
| Baseline: Average, Week 12: Very strongly |
|
| Baseline: Strongly, Week 12: Not bothered |
|
| Baseline: Strongly, Week 12: Slightly |
|
| Baseline: Strongly, Week 12: Average |
|
| Baseline: Strongly, Week 12: Strongly |
|
| Baseline: Strongly, Week 12: Very strongly |
|
| Baseline: Very strongly, Week 12: Not bothered |
|
| Baseline: Very strongly, Week 12: Slightly |
|
| Baseline: Very strongly, Week 12: Average |
|
| Baseline: Very strongly, Week 12: Strongly |
|
| Baseline: Very strongly, Week 12: Very strongly |
|
| Title | Measurements |
|---|---|
|
| Baseline: Not bothered, Week 12: Strongly |
|
| Baseline: Not bothered, Week 12: Very strongly |
|
| Baseline: Slightly, Week 12: Not bothered |
|
| Baseline: Slightly, Week 12: Slightly |
|
| Baseline: Slightly, Week 12: Average |
|
| Baseline: Slightly, Week 12: Strongly |
|
| Baseline: Slightly, Week 12: Very strongly |
|
| Baseline: Average, Week 12: Not bothered |
|
| Baseline: Average, Week 12: Slightly |
|
| Baseline: Average, Week 12: Average |
|
| Baseline: Average, Week 12: Strongly |
|
| Baseline: Average, Week 12: Very strongly |
|
| Baseline: Strongly, Week 12: Not bothered |
|
| Baseline: Strongly, Week 12: Slightly |
|
| Baseline: Strongly, Week 12: Average |
|
| Baseline: Strongly, Week 12: Strongly |
|
| Baseline: Strongly, Week 12: Very strongly |
|
| Baseline: Very strongly, Week 12: Not bothered |
|
| Baseline: Very strongly, Week 12: Slightly |
|
| Baseline: Very strongly, Week 12: Average |
|
| Baseline: Very strongly, Week 12: Strongly |
|
| Baseline: Very strongly, Week 12: Very strongly |
|
| Title | Measurements |
|---|---|
|
| Baseline: Not bothered, Week 12: Strongly |
|
| Baseline: Not bothered, Week 12: Very strongly |
|
| Baseline: Slightly, Week 12: Not bothered |
|
| Baseline: Slightly, Week 12: Slightly |
|
| Baseline: Slightly, Week 12: Average |
|
| Baseline: Slightly, Week 12: Strongly |
|
| Baseline: Slightly, Week 12: Very strongly |
|
| Baseline: Average, Week 12: Not bothered |
|
| Baseline: Average, Week 12: Slightly |
|
| Baseline: Average, Week 12: Average |
|
| Baseline: Average, Week 12: Strongly |
|
| Baseline: Average, Week 12: Very strongly |
|
| Baseline: Strongly, Week 12: Not bothered |
|
| Baseline: Strongly, Week 12: Slightly |
|
| Baseline: Strongly, Week 12: Average |
|
| Baseline: Strongly, Week 12: Strongly |
|
| Baseline: Strongly, Week 12: Very strongly |
|
| Baseline: Very strongly, Week 12: Not bothered |
|
| Baseline: Very strongly, Week 12: Slightly |
|
| Baseline: Very strongly, Week 12: Average |
|
| Baseline: Very strongly, Week 12: Strongly |
|
| Baseline: Very strongly, Week 12: Very strongly |
|
| Title | Measurements |
|---|---|
|
| Baseline: Not bothered, Week 12: Strongly |
|
| Baseline: Not bothered, Week 12: Very strongly |
|
| Baseline: Slightly, Week 12: Not bothered |
|
| Baseline: Slightly, Week 12: Slightly |
|
| Baseline: Slightly, Week 12: Average |
|
| Baseline: Slightly, Week 12: Strongly |
|
| Baseline: Slightly, Week 12: Very strongly |
|
| Baseline: Average, Week 12: Not bothered |
|
| Baseline: Average, Week 12: Slightly |
|
| Baseline: Average, Week 12: Average |
|
| Baseline: Average, Week 12: Strongly |
|
| Baseline: Average, Week 12: Very strongly |
|
| Baseline: Strongly, Week 12: Not bothered |
|
| Baseline: Strongly, Week 12: Slightly |
|
| Baseline: Strongly, Week 12: Average |
|
| Baseline: Strongly, Week 12: Strongly |
|
| Baseline: Strongly, Week 12: Very strongly |
|
| Baseline: Very strongly, Week 12: Not bothered |
|
| Baseline: Very strongly, Week 12: Slightly |
|
| Baseline: Very strongly, Week 12: Average |
|
| Baseline: Very strongly, Week 12: Strongly |
|
| Baseline: Very strongly, Week 12: Very strongly |
|
| Title | Measurements |
|---|---|
|
| Benefit: Week 2, Missing (n=303) |
|
| Benefit: Week 4, Weak benefit (n=281) |
|
| Benefit: Week 4, Strong benefit (n=281) |
|
| Benefit: Week 4, No benefit (n=281) |
|
| Benefit: Week 4, Missing (n=281) |
|
| Benefit: Week 6, Weak benefit (n=252) |
|
| Benefit: Week 6, Strong benefit (n=252) |
|
| Benefit: Week 6, No benefit (n=252) |
|
| Benefit: Week 6, Missing (n=252) |
|
| Benefit: Week 12, Weak benefit (n=277) |
|
| Benefit: Week 12, Strong benefit (n=277) |
|
| Benefit: Week 12, No benefit (n=277) |
|
| Benefit: Week 12, Missing (n=277) |
|
| Satisfaction: Week 2,Slightly satisfactory(n=302) |
|
| Satisfaction: Week 2,Very satisfactory(n=302) |
|
| Satisfaction:Week 2,Slightly unsatisfactory(n=302) |
|
| Satisfaction: Week 2, Very unsatisfactory (n=302) |
|
| Satisfaction: Week 4,Slightly satisfactory(n=282) |
|
| Satisfaction: Week 4, Very satisfactory (n=282) |
|
| Satisfaction:Week 4,Slightly unsatisfactory(n=282) |
|
| Satisfaction: Week 4, Very unsatisfactory (n=282) |
|
| Satisfaction: Week 4, Missing (n=282) |
|
| Satisfaction: Week 6,Slightly satisfactory(n=251) |
|
| Satisfaction: Week 6, Very satisfactory (n=251) |
|
| Satisfaction:Week 6,Slightly unsatisfactory(n=251) |
|
| Satisfaction: Week 6, Very unsatisfactory (n=251) |
|
| Satisfaction: Week 6, Missing (n=251) |
|
| Satisfaction: Week 12,Slightly satisfactory(n=277) |
|
| Satisfaction: Week 12, Very satisfactory (n=277) |
|
| Satisfaction:Week12,Slightly unsatisfactory(n=277) |
|
| Satisfaction: Week 12, Very unsatisfactory (n=277) |
|
| Satisfaction: Week 12, Missing (n=277) |
|
| Title | Measurements |
|---|---|
|
| Baseline: Moderate problem (n=309) |
|
| Baseline: Severe problem (n=309) |
|
| Baseline:Very severe problem (n=309) |
|
| Week 12: Not problematic at all (n=275) |
|
| Week 12: Mild problem (n=275) |
|
| Week 12: More or less a mild problem (n=275) |
|
| Week 12: Moderate problem (n=275) |
|
| Week 12: Severe problem (n=275) |
|
| Week 12: Very severe problem (n=275) |
|
|
| HRQL: Baseline (n=309) |
|
| HRQL: Change at Week 6 (n=251) |
|
| HRQL: Change at Week 12/ED (n=276) |
|
| Title | Measurements |
|---|---|
|
| Nighttime: Baseline (n=309) |
|
| Nighttime: Week 6 (n=244) |
|
| Nighttime: Week 12/ED (n=245) |
|
| Total: Baseline (n=309) |
|
| Total: Week 6 (n=244) |
|
| Total: Week 12/ED (n=245) |
|
|
| Nighttime:Percent change at Week 12/ED (n=224) |
|
| Total: Percent change at Week 6 (n=244) |
|
| Total: Percent change at Week 12/ED (n=245) |
|
|
| UI: Baseline (n=309) |
|
| UI: Week 6 (n=244) |
|
| UI: Week 12/ED (n=245) |
|
|
| UI: Percent change at Week 12/ED (n=75) |
|
| Title | Measurements |
|---|---|
|