- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01089751
Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily
September 24, 2013 updated by: Allergan
This study will investigate the safety and efficacy of Sanctura XR (trospium chloride) daily in reducing urgency, urinary frequency and urinary urge incontinence in female patients with incontinence refractory to Detrol LA (tolterodine tartrate extended release) 4 mg therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
322
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Mesa, California, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Taking Detrol® LA 4mg daily for a minimum of 1 month prior to Screening/Qualification
- Overactive Bladder syndrome with urgency, urinary frequency and urgency urinary incontinence
- Taking five or more concomitant medications (may be prescription, non-prescription, or supplement/vitamin) daily for indications other than Overactive Bladder (OAB).
Exclusion Criteria:
- Predominant stress or insensate incontinence
- History of neurogenic bladder
- Two urinary tract infections in the last six months
- Gastric by-pass (Roux-en-Y) surgery (adjustable gastric banding is allowed)
- Donated >500mL blood in the 30 days prior to the screening visit
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sanctura XR®
Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
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Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks
Other Names:
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Placebo Comparator: Placebo
Placebo once daily on an empty stomach for 14 weeks.
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Placebo once daily on an empty stomach for 14 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Patients Continent (PPC)
Time Frame: Week 14
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PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit.
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Week 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Continent Days Per Week (CDW)
Time Frame: Baseline, Week 14
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Continent Days per Week is the average of the number of times an individual has no incontinence episodes in a day within the 3-day collection period calculated as 7 x (number of dry days within the 3-day diary period) divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period.
A positive change from Baseline (more continent/fewer incontinent days per week ) indicated improvement.
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Baseline, Week 14
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Change From Baseline in Nocturic Toilet Voids
Time Frame: Baseline, Week 14
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A nocturic (nighttime) toilet void is identified if the patient marks "Yes" for both Toilet Voiding and Sleep Interruption in the 3-day bladder diary.
The daily average number of nocturic toilet voids is obtained as the sum of all nighttime toilet voids over the 3-day bladder diary period divided by number of valid diary days with at least one valid bladder diary entry during the 3-day period.
A negative change from Baseline (fewer nocturic toilet voids) indicated improvement.
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Baseline, Week 14
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Change From Baseline in Urgency-Related Toilet Voids
Time Frame: Baseline, Week 14
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Urgency-related toilet void (or urinary urgency) is identified if the patient marks "Yes" for both Urgency Association Void and Toilet Voiding in the 3-day bladder diary.
The daily average number of urgency-related voids is calculated as the sum of all urgency episodes over the 3-day bladder diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period.
A negative change from Baseline (fewer urgency related toilet voids) indicated improvement.
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Baseline, Week 14
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Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS)
Time Frame: Baseline, Week 14
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The OAB-SCS is derived from the 3-day bladder diary which includes: 1) 24-hour voiding frequency; 2) the Indevus Urgency Severity Scale (IUSS) Score (0=no urgency, 1=aware of urgency but is tolerable, 2=urgency discomfort interferes with activities/tasks, 3=extreme urgency discomfort that abruptly stops activities/tasks associated with each toilet void); and 3) the frequency of Urgency Urinary Incontinence episodes.
Each toilet void is then assigned a point value from 1 (IUSS Score=0) to 5 (UUI episode not associated with a toilet void).
The daily average OAB-SCS is then calculated based on the diary entries and assigned point values.
The lowest possible daily average OAB-SCS is 0 (corresponding to no urgency in every void).
There is no upper limit since the score is based on the number of voids per day.
Scores <= 30 indicate mild OAB, scores > 30 to 39 indicate moderate OAB, and scores >= 40 indicate severe OAB.
A negative change from Baseline indicated improvement.
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Baseline, Week 14
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Change From Baseline in Voided Volume
Time Frame: Baseline, Week 14
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Average volume of urine voided per toilet void is calculated by total volume collected in a 24-hour diary period divided by the number of individual entries of volume voided in that period.
A positive change from Baseline (greater volume voided) indicated improvement.
A negative change from Baseline (less volume voided) indicated a worsening.
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Baseline, Week 14
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Change From Baseline in Urgency Severity
Time Frame: Baseline, Week 14
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The urgency severity per toilet void is based on the Indevus Urgency Severity Scale (IUSS).
The patient recorded urinary urgency severity in a 3-day bladder diary using a 4-point scale: 0=None-no urgency (best), 1=Slight-aware of urgency but is tolerable, 2=Moderate-urgency discomfort interferes with activities/tasks, 3=Severe-extreme urgency discomfort that abruptly stops activities/tasks (worst).
Urgency Severity is calculated as the sum of all IUSS scores during the 3-day diary period divided by the number of toilet voids recorded during that period.
A negative change from Baseline indicated improvement.
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Baseline, Week 14
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Change From Baseline in Urgency Urinary Incontinence (UUI)
Time Frame: Baseline, Week 14
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Urgency urinary incontinence is identified if the patient marks "Yes" for both Accidental Leakage and Urgency Associated Void in the 3-day bladder diary, and the Urgency Severity score is ≥ 1.
Average daily episodes of UUI is calculated as the sum of all UUI episodes over 3-day diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period.
A negative change from Baseline indicated improvement.
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Baseline, Week 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
March 17, 2010
First Submitted That Met QC Criteria
March 18, 2010
First Posted (Estimate)
March 19, 2010
Study Record Updates
Last Update Posted (Estimate)
September 26, 2013
Last Update Submitted That Met QC Criteria
September 24, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Urological Agents
- Trospium chloride
Other Study ID Numbers
- GMA-SXR-09-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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