A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Estimation Study to Assess the Efficacy and Safety of Modified Release UK-369,003 in the Treatment of Men with Storage Lower Urinary Tract Symptoms (LUTS) With and Without Erectile Dysfunction (ED) - ND

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-006656-35-IT
• Date of registration: 30/11/2007
• Prospective Registration: No
• Primary sponsor: PFIZER
• Public title: A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Estimation Study to Assess the Efficacy and Safety of Modified Release UK-369,003 in the Treatment of Men with Storage Lower Urinary Tract Symptoms (LUTS) With and Without Erectile Dysfunction (ED) - ND
• Scientific title: A Multi-center, Randomized, Parallel Group, Double-blind, Placebo Controlled Estimation Study to Assess the Efficacy and Safety of Modified Release UK-369,003 in the Treatment of Men with Storage Lower Urinary Tract Symptoms (LUTS) With and Without Erectile Dysfunction (ED) - ND
• Date of first enrolment: 03/10/2007
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006656-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

France, Germany, Greece, Italy, Latvia, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male subjects aged 18 years and above, with documented clinical diagnosis of OAB as verified by the screening LUTS diary defined by: · Mean urinary frequency >/=8 times /24 hours. · Mean number of urgency episodes, with or without urgency incontinence >/=1 episode /24 hours. 2. Mean voided volume <300 ml as verified by the bladder diary completed prior to randomization. 3. Qmax >5 ml/sec with a voided volume >150 ml. 4. Stable sexual partner for the duration of the trial. 5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. 6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures.
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. History, evidence or suspicion of prostate cancer (includes total Prostate Specific Antigen (PSA) value > 10 ng/ml unless prostate cancer previously excluded by biopsy) at screening visit or during the course of the trial. 2. Post-void residual urine volume >200 ml based on bladder ultrasound at screening visit. 3. Documented urinary tract infection (UTI) at screening visit; subjects with a positive (1+ or greater) leukocyte or nitrite result in urine dipstick test will be excluded unless UTI can be ruled out via urine culture. 4. Greater than 1+ of hematuria on dipstick test at screening visit, unless fully investigated prior to randomization (baseline visit) to rule out significant urological disease. 5. History of relevant urological surgery or procedures that may contribute to LUTS (e.g. prostatectomy, bladder neck surgery, minimally invasive procedures of the prostate, prostatic stent insertion, pelvic irradiation, cystoscopy < 30 days prior to randomization at baseline visit). 6. Chronic persistent local lower urinary tract pathology (e.g. bladder neck contracture, prostatitis, bladder stone, cystitis, urethral stricture, carcinoma, large bladder diverticulum, recurrent gross hematuria). 7. Known primary neurological conditions such as multiple sclerosis, Parkinson?s disease, or other neurological diseases known to affect bladder function. 8. History of catheterization for outflow obstruction in the previous 12 months prior to screening visit (includes intermittent self-catheterization). 9. Use of any electrostimulation or bladder training in the past 30 days or who are expected to start such treatment during the study. 10. Subjects with a total volume voided of > 3000 ml on average per 24 hours, as confirmed by the LUTS diary completed prior to randomization. 11. Subjects receiving or who are likely to receive any of the following medications or treatments during the trial period: · a-blockers, muscarinic receptor antagonists, PDE5 inhibitors, and agents known to affect vesico-urethral function or erectile function (including vacuum devices). Such treatments must be terminated at least four weeks prior to randomization at baseline visit and must not be taken at any time during the trial. · 5-a-RIs (unless at stable dose for six months prior to randomization at baseline visit, and stable dose maintained through duration of the trial). · Diuretics, beta-blockers or other anti-hypertensive agents (unless stable for four weeks prior to visit 3 (baseline) and stable dose maintained throughout the duration of the trial). · Nitrates or nitric oxide donors in any form on either regular or intermittent basis (oral, sublingual, buccal, transdermal, inhalation or aerosols). · Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, miconazole, clotrimazole, nefazadone, clarithromycin, troleandomycin, ritonavir and saquinavir). Topical agents are permitted. · Warfarin. 12. Significant allergy to or known hypersensitivity or intolerance to PDE5 inhibitors or any of the excipients in the formulation. 13. Increased susceptibility to vasodilators including those subjects with left ventricular outflow obstruction (e.g., hypertrophic obstructive cardiomyopathy). 14. Poorly controlled type I or type II diabetes mellitus as defined by HbA1C >7% at screening visit. 15. Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporally associated with the

Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Storage male lower urinary tract symptoms (LUTS) with and without erectile dysfunction (ED).
MedDRA version: 9.1 Level: LLT Classification code 10046566 Term: Urinary tract disorder

Intervention(s)

Product Name: UK-369,003-besylate
Pharmaceutical Form: Modified-release tablet
CAS Number: 334827-98-4
Current Sponsor code: UK-369,003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use

Product Name: UK-369,003-besylate
Pharmaceutical Form: Modified-release tablet
CAS Number: 334827-98-4
Current Sponsor code: UK-369,003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use

Product Name: UK-369,003-besylate
Pharmaceutical Form: Modified-release tablet
CAS Number: 334827-98-4
Current Sponsor code: UK-369,003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use

Product Name: UK-369,003-besylate
Pharmaceutical Form: Modified-release tablet
CAS Number: 334827-98-4
Current Sponsor code: UK-369,003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: · Estimate the efficacy of UK-369,003 MR versus placebo for the treatment of storage male LUTS with and without ED.

Primary end point(s): 1. LUTS diary: a. Mean voided volume b. Urgency episode frequency c. Severity of urgency episodes d. Micturition frequency. e. Normalized micturition frequency (NMF) f. Incontinence episode frequencyg. Micturition episodes associated with urgencyh. Nocturnal frequency 2. International Prostate Symptom Score (IPSS)3. Overactive Bladder questionnaire ? Short Form (OAB-q SF) 4. Patient Perception of Bladder Condition (PPBC) 5. International Consultation on Incontinence Questionnaire ? Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)6. Erectile Function (EF) domain of International Index of Erectile Function (IIEF)7. Quality of Erection questionnaire (QEQ)8. Patient Reported Treatment Impact questionnaire (PRTI)9. Population Pharmacokinetics

Secondary Objective: · To evaluate the safety and tolerability of UK-369,003 in men with storage LUTS with and without ED. · Characterize the dose response relationship of UK-369,003 in men with storage LUTS with and without ED.

Secondary ID(s)

2006-006656-35-FR

A3711047