NCT00282932CompletedPhase 4
A Randomized, Double Blind, Placebo Controlled Detrol LA "Add-On" To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.82 sites in 10 countries600 target enrollmentStarted: January 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 600
- Locations
- 82
- Primary Endpoint
- Patient Perception of Bladder Condition at 12 weeks of treatment
Study Overview
Brief Summary
An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction.
Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary).
Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Symptoms of OAB (frequency more than 8 per day and Urgency more than 1 episode per day confirmed by bladder diary)
Exclusion Criteria
- •Significant hepatic or renal disease, history of radiation treatment
Outcomes
Primary Outcomes
Patient Perception of Bladder Condition at 12 weeks of treatment
Secondary Outcomes
- 1)To evaluate the additional benefit of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence: a)On OAB symptoms as
- assessed by 5-day voiding bladder diaries including Urinary Sensation Scale, b)On symptoms as assessed by the International Prostate Symptom Score (IPSS), c)On patient perception of treatment benefit as assessed by the Patient Perception of Treatment
- Benefit Questionnaire (PPTB) , d)On patient perception of bladder condition as assessed by the change in the PPBC after 4 weeks of treatment, e)On bothersome quality of life (QoL) symptoms as assessed by the Overactive Bladder Questionnaire (OAB-q),
- f)On sexual QoL as assessed by the ICIQ-MLUTSsex Questionnaire , g)On patient satisfaction with medication as assessed by the Overactive Bladder Treatment Satisfaction Questionnaires (OAB-s), h)On nocturia bothersome measure as assessed by the Nocturia
- Quality-of-Life Questionnaire, 2)To evaluate the safety and tolerability of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency
- incontinence.
Investigators
Study Sites (82)
Loading locations...
Similar Trials
Completed
Not Applicable
Assessment of the Efficacy of Andrographis Paniculata in Subjects With Mild to Moderate OsteoarthritisKnee OsteoarthritisNCT03262792Vedic Lifesciences Pvt. Ltd.108
Completed
Phase 2
A Double-blind Randomized Placebo-controlled Study Comparing Epanova and Fenofibrate on Liver Fat in Overweight Subjects.Non-alcoholic Fatty Liver Disease (NAFLDHypertriglyceridemiaNCT02354976AstraZeneca78
Completed
Phase 2
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic PatientsT2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)NCT02279407AstraZeneca223
Completed
Not Applicable
Clinical Trial to Evaluate the Effect of a Probiotic in AcneAcne VulgarisAcneNCT04570319Bionou Research, S.L.81
Completed
Phase 2
Safinamide for Multiple System Atrophy (MSA)Multiple System AtrophyNCT03753763Zambon SpA49