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NCT00282932 Clinical Trial

Detrol LA In Men With Overactive Bladder.

Overactive Bladder (OAB) Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00282932
Other study ID # A6121127
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2006
Est. completion date May 14, 2007

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Detrol LA

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Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  Italy,  Korea, Republic of,  Mexico,  Norway,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Perception of Bladder Condition at 12 weeks of treatment
Secondary 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
Secondary 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
Secondary 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),
Secondary 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
Secondary 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
Secondary incontinence.
See also
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Completed NCT02294396 - Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron. Phase 4
Completed NCT01936870 - Drug Use Investigation for Toviaz
Completed NCT03846895 - Vaginal CO2 Laser in Postmenopausal Women With Overactive Bladder Syndrome (OAB) N/A
Completed NCT03903094 - A Study on Anticholinergic Use: Attribution of Overactive Bladder (OAB) Medications to the Anticholinergic Burden
Terminated NCT04451382 - PTNS vs Botox of Refractory OAB
Terminated NCT04641975 - A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB) Phase 3
Completed NCT00366002 - Patient's Perception of Treatment Outcome With Darifenacin by Patients With Overactive Bladder Phase 4
Completed NCT02138747 - A Study to Evaluate Tolerability and Participants Preference Between Mirabegron and Tolterodine Extended Release (ER) in Participants With Overactive Bladder (OAB) Phase 4
Completed NCT03602508 - Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
Completed NCT03572231 - A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China
Completed NCT05211193 - Open Label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous URIS I in the Treatment of Overactive Bladder (OAB).
Completed NCT04562090 - A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder Phase 4
Completed NCT01639794 - Vesitirim™ in Men Postmarketing Observational Study N/A
Completed NCT00742833 - A Phase II Study of KUC-7483 in Patients With Overactive Bladder Phase 2
Withdrawn NCT01317810 - A Study Measuring and Tracking Changes in Overactive Bladder (OAB) Medication N/A

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