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| Name | Class |
|---|---|
| Astellas Pharma Canada, Inc. | INDUSTRY |
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The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).
This study is a prospective randomized, double-blind, double-dummy, multicentre, 2-arm (1 Active, Active Control) comparative parallel group study to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solifenacin | Experimental | Solifenacin succinate: 5 mg tablets, taken orally, once daily |
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| Oxybutynin IR | Active Comparator | Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| solifenacin | Drug | Oral |
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| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event | The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit | 8 weeks |
| The Severity of Dry Mouth Reported as an Adverse Event | The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE). Dry mouth severity was categorized as "mild" (relieved with fluid/hard candy), "moderate" (dry mouth and throat with no difficulty swallowing solid food/water) & "severe" (very dry mouth & throat, difficulty swallowing solid food without water) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary | Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet. The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Canada, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Calgary | Alberta | T2V 4R6 | Canada | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20303119 | Background | Herschorn S, Stothers L, Carlson K, Egerdie B, Gajewski JB, Pommerville P, Schulz J, Radomski S, Drutz H, Barkin J, Paradiso-Hardy F. Tolerability of 5 mg solifenacin once daily versus 5 mg oxybutynin immediate release 3 times daily: results of the VECTOR trial. J Urol. 2010 May;183(5):1892-8. doi: 10.1016/j.juro.2010.01.012. Epub 2010 Mar 29. | |
| 21175373 |
| Label | URL |
|---|---|
| Link to prescribing information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Solifenacin | Solifenacin succinate: 5 mg tablets, taken orally, once daily |
| FG001 | Oxybutynin IR | Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| oxybutynin immediate release | Drug | Oral |
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| Baseline and 8 Weeks |
| Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary | Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine. The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline. | Baseline and 8 weeks |
| Edmonton |
| Alberta |
| T5H 3V9 |
| Canada |
| Vancouver | British Columbia | V6T 2B5 | Canada |
| Victoria | British Columbia | V8T 5G1 | Canada |
| Halifax | Nova Scotia | B3H 3A7 | Canada |
| Guelph | Ontario | N1H 5J1 | Canada |
| Kitchener | Ontario | N2N 2B9 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Toronto | Ontario | M5G 1Z5 | Canada |
| Toronto | Ontario | M5T 2S8 | Canada |
| Toronto | Ontario | M6A 3B5 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Herschorn S, Pommerville P, Stothers L, Egerdie B, Gajewski J, Carlson K, Radomski S, Drutz H, Schulz J, Barkin J, Hirshberg E, Corcos J. Tolerability of solifenacin and oxybutynin immediate release in older (> 65 years) and younger (</= 65 years) patients with overactive bladder: sub-analysis from a Canadian, randomized, double-blind study. Curr Med Res Opin. 2011 Feb;27(2):375-82. doi: 10.1185/03007995.2010.541433. Epub 2010 Dec 23. |
| 20690893 | Derived | Herschorn S, Vicente C, Piwko C. Canadian cost-effectiveness analysis of solifenacin compared to oxybutynin immediate-release in patients with overactive bladder. J Med Econ. 2010;13(3):508-15. doi: 10.3111/13696998.2010.509244. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Solifenacin | Solifenacin succinate: 5 mg tablets, taken orally, once daily |
| BG001 | Oxybutynin IR | Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event | The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit | Data represents ITT Population: all randomized subjects | Posted | Number | participants | 8 weeks |
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| Primary | The Severity of Dry Mouth Reported as an Adverse Event | The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE). Dry mouth severity was categorized as "mild" (relieved with fluid/hard candy), "moderate" (dry mouth and throat with no difficulty swallowing solid food/water) & "severe" (very dry mouth & throat, difficulty swallowing solid food without water) | Data represents ITT Population: all randomized subjects | Posted | Number | participants | 8 weeks |
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| Secondary | Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary | Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet. The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline. | Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study | Posted | Mean | Standard Deviation | Micturitions per day | Baseline and 8 Weeks |
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| Secondary | Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary | Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine. The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline. | Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study | Posted | Mean | Standard Deviation | urgency episodes per day | Baseline and 8 weeks |
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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 | Solifenacin | Solifenacin succinate: 5 mg tablets, taken orally, once daily | 3 | 68 | 36 | 68 | ||
| EG001 | Oxybutynin IR | Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day | 0 | 64 | 56 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fracture, right foot | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Cervical adenocarcinoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
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| Worsening depression | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Eye | Eye disorders | MedDRA 9.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | medDRA 9.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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The relatively high incidence of AEs, specifically dry mouth, in both groups may be a result of the direct questioning methodology used. Subjects were also informed the primary objectives were the relative frequency and severity of dry mouth.
PIs may not present or publish data prior to publication of the multicenter data or 12 months have elapsed following database lock.
Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of up to 90 days from the time submitted to the sponsor for review.
PIs may not engage in contacts with the media related to the study, study interventions or data without prior written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Astellas Medical Monitor | Astellas Pharma Global Development | ClinicalTrials@us.astellas.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| C005419 | oxybutynin |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Title | Measurements |
|---|---|
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| Male |
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| Black |
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| Asian |
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| Aboriginal |
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| Hispanic |
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| Other |
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