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 - ND

• Conditions: Overactive Bladder in Men; MedDRA version: 6.1Level: PTClassification code 10046494

• Registration Number: EUCTR2005-004452-13-IT
• Lead Sponsor: PFIZER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-15
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 608

Inclusion Criteria

1. Men aged 40 years and above with no upper limit of age 2. On a stable dose of an alpha-blocker for at least 1 month 3. Persistent symptoms of OAB as verified by the screening 5 day micturition diary, defined by a. Mean urinary frequency / 8 times/24 hours b. Mean number of urgency episodes, with/without urgency incontinence, / 1 episode/24 hours with a Urinary Sensation Scale rating of / 3 in the micturition diary 4. A rating of the bladder condition at Baseline visit 2 prior to randomization as Some Moderate Problems , Severe Problems , or Many Severe Problems on the Patient Perception of Bladder Condition PPBC questionnaire 5. The ability and willingness to correctly complete the micturition diary and various questionnaires, comply with scheduled visits and comply with trial procedures 6. The capability of understanding and having signed the informed consent form after full discussion of the research, nature of the treatment, and its risks and benefits
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous history of acute urinary retention requiring catheterization 2.A post void residual urinary volume greater than 200mls at Screening visit 1 3.Poor detrusor function or clinically relevant bladder outlet obstruction based on investigator s judgment as shown in a flow rate and residual volume measurement at Screening visit 1 4.A 5-alpha reductase inhibitor if started less than 6 months prior to Screening visit 1 5.Urinary tract infection UTI , including bacterial prostatitis, confirmed by a positive urine test or recurrent UTI defined as being treated for 3 episodes of symptomatic UTI in the past 12 months 6.A known history of bladder outlet obstruction due to vesical neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor 7.A known history of uninvestigated haematuria, interstitial cystitis, genitor-urinary tuberculosis, bladder calculi or detrusor-sphincter dyssynergia 8.Previous history of prostatic surgery/intervention including minimally invasive treatments , or other major urethral and/or bladder surgery or if subjects have any AEs requiring prostate surgery/intervention to relieve bladder outlet flow obstruction 9.History or suspicion of prostate cancer including a serum PSA prostate specific antigen concentration of greater than 10 ng/ml on repeat testing 10.History of radiation treatment external or interstitial to pelvic organs or external genitalia for any reason. 11.Any condition which, in the opinion of the investigator, makes the patient unsuitable, or with contraindications for inclusion, e.g., uncontrolled narrow-angled glaucoma, retention of urine, gastric retention or hypersensitivity to Detrol LAO or any of the ingredients 12.Concomitant overt peripheral and central neurologic diseases, such as spinal cord injury or multiple sclerosis 13.Significant hepatic or renal disease, defined as twice the upper limit of the reference ranges regarding serum concentrations of AST, ALT, ALP, urea nitrogen, or creatinine 14.Expectation of initiating treatment with any other drug for OAB or any drug with significant anticholinergic, antispasmodic, parasympathetic, or cholinergic agonistic effects during the trial 15.Treatment with potent CYP3A4 inhibitors, such as macrolide antibiotics erythromycin, clarithromycin , immunosuppressants cyclosporine , azole antifungal agents i.e., ketoconazole, itraconazole , protease inhibitors, or the expectation to start such a treatment during the trial 16.Administration of medications capable of inducing hepatic enzyme metabolism or transport e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John s Wort in the past 30 days 17.Use of any electrostimulation or bladder training in the past 30 days 18.Use of an indwelling catheter or an intermittent self-catheterization program 19.Use of any other investigational drug in the past 2 months 20.Treatment with an anti-cholinergic within the past 30 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified