Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR) (VECTOR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00431041 |
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Recruitment Status :
Completed
First Posted : February 2, 2007
Results First Posted : January 11, 2010
Last Update Posted : June 8, 2010
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Overactive Bladder | Drug: solifenacin Drug: oxybutynin immediate release | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 132 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | VECTOR: A Randomized Double-blind Study to Assess the Safety and Efficacy of Solifenacin (Vesicare®) in Comparison to Oxybutynin for Overactive Bladder Patients |
| Study Start Date : | December 2006 |
| Actual Primary Completion Date : | February 2008 |
| Actual Study Completion Date : | February 2008 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Solifenacin
Solifenacin succinate: 5 mg tablets, taken orally, once daily
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Drug: solifenacin
Oral
Other Names:
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Active Comparator: Oxybutynin IR
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
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Drug: oxybutynin immediate release
Oral |
- The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event [ Time Frame: 8 weeks ]The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit
- The Severity of Dry Mouth Reported as an Adverse Event [ Time Frame: 8 weeks ]
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)
- Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary [ Time Frame: Baseline and 8 Weeks ]
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.
- Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary [ Time Frame: Baseline and 8 weeks ]
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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults 18 years and older.
- Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: > 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)
Exclusion Criteria:
- Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones
- Clinically significant outflow obstruction
- Uncontrolled narrow angle glaucoma, urinary, or gastric retention
- Severe renal or hepatic impairment
- Chronic severe constipation or history of diagnosed GI obstructive disease
- Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
- Diagnosis or history of neurogenic bladder
- History of bladder or pelvic cancer
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431041
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2V 4R6 | |
| Edmonton, Alberta, Canada, T5H 3V9 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V6T 2B5 | |
| Victoria, British Columbia, Canada, V8T 5G1 | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada, B3H 3A7 | |
| Canada, Ontario | |
| Guelph, Ontario, Canada, N1H 5J1 | |
| Kitchener, Ontario, Canada, N2N 2B9 | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Toronto, Ontario, Canada, M5G 1Z5 | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Toronto, Ontario, Canada, M6A 3B5 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Study Director: | Use Central Contact | Astellas Pharma Canada, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc |
| ClinicalTrials.gov Identifier: | NCT00431041 |
| Other Study ID Numbers: |
VES-001 |
| First Posted: | February 2, 2007 Key Record Dates |
| Results First Posted: | January 11, 2010 |
| Last Update Posted: | June 8, 2010 |
| Last Verified: | June 2010 |
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Solifenacin succinate Oxybutynin immediate release Xerostomia Overactive bladder |
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Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Solifenacin Succinate Oxybutynin Muscarinic Antagonists Cholinergic Antagonists |
Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents |