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The purpose of this study is to evaluate the efficacy and safety of TAC-302 in detrusor underactivity patients with overactive bladder.
The main purpose of this study is to assess the efficacy of TAC-302 for 12 weeks in detrusor underactivity patients with overactive bladder by measuring the following parameters of pressure-flow study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAC-302 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAC-302 | Drug | TAC-302 200 mg administered orally twice per day after meals, for 12 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Mean BCI for Male From Baseline to Week 12 | BCI indicates maxim um detrusor pressure at peak urine flow (PdetQmax) + 5 × peak urine flow rate (Qmax): PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in men, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 150, normal 100-150, and weak < 100. No theoretical minimum and maximum value of the scale range exists. | Baseline to Week 12 |
| Changes in the Mean PIP1 for Female From Baseline to Week 12 | PIP1 indicates PdetQma x + Qmax: PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in women, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 75, normal 30-75, and weak < 30. No theoretical minimum and maximum value of the scale range exists. | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Mean BVE From Baseline to Week 12 (Overall) | BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography. | Baseline to Week 12 |
| Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taiho Pharmaceutical Co., Ltd | Taiho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taiho Pharmaceutical Co., Ltd selected site | Kumamoto | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36205739 | Derived | Yoshida M, Gotoh M, Yokoyama O, Kakizaki H, Yamanishi T, Yamaguchi O. Efficacy of TAC-302 for patients with detrusor underactivity and overactive bladder: a randomized, double-blind, placebo-controlled phase 2 study. World J Urol. 2022 Nov;40(11):2799-2805. doi: 10.1007/s00345-022-04163-4. Epub 2022 Oct 7. |
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This study was conducted at 21 medical institutions in Japan and the study period was from September 9, 2017 to November 14, 2019.
Of the 213 patients who gave informed consent and received screening tests, 18 patients were withdrawn at screening. The number of patients enrolled in the observation period was 195 patients, but after the end of the observation period, 76 patients were determined to be eligible for enrollment in the treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | TAC-302 | TAC-302: TAC-302 200 mg administered orally twice per day after meals, for 12 weeks. |
| FG001 | Placebo | Placebo: Placebo administered orally twice per day after meals, for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per protocol set (PPS) was used for the analysis. PPS included all patients in the Full analysis set (FAS) with no inclusion/exclusion criteria violations, who were compliant for ≥ 80% of the treatment period, were not administered any prohibited concomitant medication or therapy during the study period, and had a week 12 evaluation of the primary endpoint. FAS included all patients who took the study drug at least once and had ≥ 1 efficacy measurement before and during the treatment period.
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| ID | Title | Description |
|---|---|---|
| BG000 | TAC-302 | TAC-302: TAC-302 200 mg administered orally twice per day after meals, for 12 weeks. |
| BG001 | Placebo | Placebo: Placebo administered orally twice per day after meals, for 12 weeks. |
| 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 | Changes in the Mean BCI for Male From Baseline to Week 12 | BCI indicates maxim um detrusor pressure at peak urine flow (PdetQmax) + 5 × peak urine flow rate (Qmax): PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in men, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 150, normal 100-150, and weak < 100. No theoretical minimum and maximum value of the scale range exists. | PPS was used for the analysis. This analysis was conducted only in male patients in the PPS. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 12 |
|
Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period)
All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once.
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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 | TAC-302 | TAC-302: TAC-302 200 mg administered orally twice per day after meals, for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deafness neurosensory | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Taiho Pharmaceutical Co., Ltd. | Clinical Trial Registration Contact | +81-3-3293-2455 | toiawase@taiho.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 19, 2018 | Aug 16, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2020 | Aug 16, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077295 | Urinary Bladder, Underactive |
| D053201 | Urinary Bladder, Overactive |
| D059411 | Lower Urinary Tract Symptoms |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000654176 | tac-302 |
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| Placebo |
| Drug |
Placebo administered orally twice per day after meals, for 12 weeks. |
|
BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography. |
| Baseline to Week 12 |
| Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline) | BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography. | Baseline to Week 12 |
| Number of Micturitions Per 24 Hours at Baseline and Week 12 | On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinations per 24 hours was calculated. The patients with at least 8 urinations per 24 hours at registration were included in this study. | Baseline to Week 12 |
| Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12 | On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinary urgency episodes per 24 hours was calculated. The patients with at least one urinary urgency episode per 24 hours at registration were included in this study. | Baseline to Week 12 |
| Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12 | Overactive bladder symptoms were evaluated using the OABSS. The OABSS Total Score is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The range of scores is from 0 to 15 points with a higher score indicating greater severity. A score ≤ 5 was determined to be mild, a score of 6 to 11 was determined to be moderate and a score ≥ 12 was determined to be severe. | Baseline to Week 12 |
| Number of Participants With Adverse Events | In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms. | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
| Number of Participants With Adverse Drug Reactions | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
| Number of Participants With Serious Adverse Events | In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms. | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
| Number of Participants With Adverse Events Leading to Death | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
| Number of Participants With Adverse Events Leading to Dose Discontinuation | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
| Number of Participants With Adverse Events Leading to Dose Interruption | In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms. | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Duration of lower urinary tract symptoms | Mean | Standard Deviation | months |
|
| Duration of lower urinary tract symptoms | Median | Full Range | months |
|
| Bladder voiding efficiency (BVE) | Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography | Mean | Standard Deviation | % |
|
| Bladder voiding efficiency (BVE) | Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography | Median | Full Range | % |
|
| Bladder contractility index (BCI) (Only Male) | Maximum detrusor pressure at peak urine flow (PdetQmax) + 5 × peak urine flow rate (Qmax): PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in men, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 150, normal 100-150, and weak < 100. No theoretical minimum and maximum value of the scale range exists. | This analysis was conducted only in male patients. | Mean | Standard Deviation | Score on a scale |
|
| Bladder contractility index (BCI) (Only Male) | Maximum detrusor pressure at peak urine flow (PdetQmax) + 5 × peak urine flow rate (Qmax): PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in men, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 150, normal 100-150, and weak < 100. No theoretical minimum and maximum value of the scale range exists. | This analysis was conducted only in male patients. | Median | Full Range | Score on a scale |
|
| Projected isovolumetric pressure 1 (PIP1) (Only Female) | PdetQmax + Qmax: PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in women, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 75, normal 30-75, and weak < 30. No theoretical minimum and maximum value of the scale range exists. | This analysis was conducted only in female patients. | Mean | Standard Deviation | Score on a scale |
|
| Projected isovolumetric pressure 1 (PIP1) (Only Female) | PdetQmax + Qmax: PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in women, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 75, normal 30-75, and weak < 30. No theoretical minimum and maximum value of the scale range exists. | This analysis was conducted only in female patients. | Median | Full Range | Score on a scale |
|
| OG001 | Placebo | Placebo: Placebo administered orally twice per day after meals, for 12 weeks. |
|
|
|
| Primary | Changes in the Mean PIP1 for Female From Baseline to Week 12 | PIP1 indicates PdetQma x + Qmax: PdetQmax and Qmax denotes detrusor pressure at maximum flow and maximum flow rate in pressure flow study, respectively. This index is used to assess detrusor contractility in women, with a higher value indicating greater detrusor contractility. Contractility can be divided into strong > 75, normal 30-75, and weak < 30. No theoretical minimum and maximum value of the scale range exists. | PPS was used for the analysis. This analysis was conducted only in female patients in the PPS. | Posted | Mean | Standard Deviation | Score on a scale | Baseline to Week 12 |
|
|
|
|
| Secondary | Changes in the Mean BVE From Baseline to Week 12 (Overall) | BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography. | FAS was used for the analysis. Therefore, the values presented here differ from those in the Baseline Characteristics module based on PPS. | Posted | Mean | Standard Deviation | percentage | Baseline to Week 12 |
|
|
|
|
| Secondary | Changes in the Mean BVE From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 50 mL at Baseline) | BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography. | FAS was used for the analysis. Therefore, the values presented here differ from those in the Baseline Characteristics module based on PPS. This analysis was conducted in the subgroup of patients with post void residual ≥ 50 mL at baseline in the FAS. | Posted | Mean | Standard Deviation | percentage | Baseline to Week 12 |
|
|
|
|
| Secondary | Changes in the Mean BVE for Female From Baseline to Week 12 (In the Subgroup of Patients With Post Void Residual ≥ 100 mL at Baseline) | BVE indicates Voided volume / (voided volume + post void residual): calculated from the voided volume measured by uroflowmetry and the post void residual measured by ultrasonography. | FAS was used for the analysis. Therefore, the values presented here differ from those in the Baseline Characteristics module based on PPS. This analysis was conducted In the subgroup of patients with post void residual ≥ 100 mL at baseline in the FAS. | Posted | Mean | Standard Deviation | percentage | Baseline to Week 12 |
|
|
|
|
| Secondary | Number of Micturitions Per 24 Hours at Baseline and Week 12 | On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinations per 24 hours was calculated. The patients with at least 8 urinations per 24 hours at registration were included in this study. | FAS was used for the analysis. | Posted | Mean | Standard Deviation | Events | Baseline to Week 12 |
|
|
|
| Secondary | Number of Urinary Urgency Episodes Per 24 Hours at Baseline and Week 12 | On the basis of information from bladder diary records in the 3 days directly before each evaluation timepoint, an average of urinary urgency episodes per 24 hours was calculated. The patients with at least one urinary urgency episode per 24 hours at registration were included in this study. | FAS was used for the analysis. | Posted | Mean | Standard Deviation | Events | Baseline to Week 12 |
|
|
|
| Secondary | Overactive Bladder Symptom Score (OABSS) Total Score at Baseline and Week 12 | Overactive bladder symptoms were evaluated using the OABSS. The OABSS Total Score is the sum of four symptom scores: daytime frequency (score 0-2), nighttime frequency (score 0-3), urgency (score 0-5), and urgency incontinence (score 0-5). The range of scores is from 0 to 15 points with a higher score indicating greater severity. A score ≤ 5 was determined to be mild, a score of 6 to 11 was determined to be moderate and a score ≥ 12 was determined to be severe. | FAS was used for the analysis. | Posted | Mean | Standard Deviation | points | Baseline to Week 12 |
|
|
|
| Secondary | Number of Participants With Adverse Events | In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms. | All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once. | Posted | Count of Participants | Participants | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
|
|
|
| Secondary | Number of Participants With Adverse Drug Reactions | All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once. | Posted | Count of Participants | Participants | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
|
|
|
| Secondary | Number of Participants With Serious Adverse Events | In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms. | All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once. | Posted | Count of Participants | Participants | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
|
|
|
| Secondary | Number of Participants With Adverse Events Leading to Death | All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once. | Posted | Count of Participants | Participants | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
|
|
|
| Secondary | Number of Participants With Adverse Events Leading to Dose Discontinuation | All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once. | Posted | Count of Participants | Participants | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
|
|
|
| Secondary | Number of Participants With Adverse Events Leading to Dose Interruption | In tabulation of adverse events, the diagnoses entered on eCRFs were coded using the medical dictionary for regulatory activities (MedDRA) ver.22.1, and were presented as MedDRA preferred terms. | All treated patients in the treatment period were used for the analysis. This analysis set includes patients enrolled in the treatment period who took the investigational drug at least once. | Posted | Count of Participants | Participants | Baseline to Week 13 (12 weeks in treatment period and 1 week in Follow-up period) |
|
|
|
| 0 |
| 52 |
| 2 |
| 52 |
| 24 |
| 52 |
| EG001 | Placebo | Placebo: Placebo administered orally twice per day after meals, for 12 weeks. | 0 | 24 | 1 | 24 | 9 | 24 |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.1 | Systematic Assessment |
|
| Bacteriuria | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Periodontitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Pyuria | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Vulvitis | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Enterocolitis viral | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Tooth dislocation | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Urethral pain | Renal and urinary disorders | MedDRA 22.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| t-test, 2 sided |
| 0.138 |
| Mean Difference (Final Values) |
| 4.926 |
| Standard Deviation |
| 7.620 |
| 2-Sided |
| 95 |
| -2.121 |
| 11.973 |
| Superiority |
| TAC-302 group vs. Placebo group for changes in the mean PIP1 from baseline to Week 12 | t-test, 2 sided | 0.157 | Mean Difference (Final Values) | 5.678 | Standard Error of the Mean | 3.861 | 2-Sided | 95 | -2.375 | 13.731 | Superiority |
| BVE at Week 12 |
|
|
| t-test, 2 sided |
| 0.570 |
| Mean Difference (Final Values) |
| 2.42 |
| Standard Deviation |
| 20.09 |
| 2-Sided |
| 95 |
| -6.27 |
| 11.10 |
| Superiority |
| TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12 | t-test, 2 sided | 0.178 | Mean Difference (Final Values) | 8.49 | Standard Error of the Mean | 6.24 | 2-Sided | 95 | -3.96 | 20.95 | Superiority |
| BVE at Week 12 |
|
|
| t-test, 2 sided |
| 0.489 |
| Mean Difference (Final Values) |
| 2.88 |
| Standard Deviation |
| 15.70 |
| 2-Sided |
| 95 |
| -5.81 |
| 11.58 |
| Superiority |
| TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12 | t-test, 2 sided | 0.031 | Mean Difference (Final Values) | 15.53 | Standard Error of the Mean | 6.96 | 2-Sided | 95 | 1.48 | 29.58 | Superiority |
| BVE at Week 12 |
|
|
| t-test, 2 sided |
| 0.708 |
| Mean Difference (Final Values) |
| 2.10 |
| Standard Deviation |
| 17.18 |
| 2-Sided |
| 95 |
| -10.19 |
| 14.40 |
| Superiority |
| TAC-302 group vs. Placebo group for changes in the mean BVE from baseline to Week 12 | t-test, 2 sided | 0.025 | Mean Difference (Final Values) | 21.47 | Standard Error of the Mean | 9.02 | 2-Sided | 95 | 2.96 | 39.98 | Superiority |
| Number of micturitions per 24 hours at Week 12 |
|
|
| Number of urinary urgency episodes per 24 hours at Week 12 |
|
|
| OABSS total score at Week 12 |
|
|
| Constipation |
|
| Dental caries |
|
| Diarrhea |
|
| Diverticulum intestinal haemorrhagic |
|
| Glossitis |
|
| Haematochezia |
|
| Nausea |
|
| Vomiting |
|
| Pyrexia |
|
| Bacteriuria |
|
| Bronchitis |
|
| Cystitis |
|
| Gastroenteritis |
|
| Herpes virus infection |
|
| Influenza |
|
| Nasopharyngitis |
|
| Periodontitis |
|
| Pharyngitis |
|
| Pyuria |
|
| Urinary tract infection |
|
| Vulvitis |
|
| Enteritis infectious |
|
| Enterocolitis viral |
|
| Compression fracture |
|
| Fracture |
|
| Subdural haematoma |
|
| Contusion |
|
| Post procedural haematuria |
|
| Meniscus injury |
|
| Tooth dislocation |
|
| Blood creatinine phosphokinase increased |
|
| Back pain |
|
| Pain in extremity |
|
| Headache |
|
| Dysuria |
|
| Renal colic |
|
| Urethral pain |
|
| Prostatitis |
|
| Cough |
|
| Dermatitis contact |
|
| Miliaria |
|
| Rash |
|
| Orthostatic hypotension |
|
| Subdural haematoma |
|
| Diverticulum intestinal haemorrhagic |
|
| Enterocolitis viral |
|
| Diverticulum intestinal haemorrhagic |
|