Lower Urinary Tract Symptoms MedDRA version: 8.1 Level: LLT Classification code 10024981 Term: Lower urinary tract infection
Conditions
Interventions
Product Name: UK-369,003
Pharmaceutical Form: Modified-release tablet
CAS Number: 334827-98-4
Other descriptive name: UK-369,003
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
Pfizer Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: *Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) =13 at both screening and baseline visit. *Clinical diagnosis of BPH *Qmax 5 to 15 ml/sec with a voided volume of >150 ml at screening visit. *Urodynamically defined bladder outlet obstruction based on bladder outlet obstruction index >40; calculated as PdetQmax –2Qmax and measured at visit 2 (baseline). *A minimum of 50% of the patient population will also have urodynamically confirmed DO (an involuntary detrusor contraction of = 10cm H2O during baseline filling cystometry and volume to first contraction = 350ml) *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. *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
Exclusion criteria: *History, evidence or suspicion of prostate cancer (includes total PSA value > 10 ng/ml unless prostate cancer previously excluded by biopsy) *Post-void residual urine volume >200 ml based on bladder ultrasound at screening *Documented UTI; 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. *Greater than 1+ of hematuria on dipstick test, unless fully investigated prior to randomization to rule out significant urological disease. *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 7%. *Loss of vision in one eye due to non-arteritic ischemic optic neuropathy (NAION) regardless of whether or not this event was temporarily associated with the use of a PDE5 inhibitor. *Hereditary degenerative retinal disorders (e.g. retinitis pigmentosa). *History of recurrent syncope or evidence of low blood pressure (BP) ( 20 mmHg or diastolic BP > 10 mmHg on standing. *Any relevant clinically significant abnormalities on the screening physical examination or laboratory tests including patients with moderate liver function tests abnormalities (>1.5 x upper limit of normal) and renal function abnormalities (serum creatinine =2.5 mg/dl or =220 µmol/l). *Family history of prolonged QT syndrome or who themselves have a QTc of >450msec at the screening visit as measured by a 12-lead supine ECG. *Risk of priapism e.g. sickle cell disease, multiple myeloma and myeloproliferative disorders (e.g. myeloid leukemia, polycythemia, thrombocythemia). *Subjects currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: de
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • A pilot study to assess the urodynamic changes induced by 100mg MR formulation of UK-369,003 vs. placebo in men with LUTS. • Assess the safety and tolerability of UK-369,003 in men with LUTS;Secondary Objective: ;Primary end point(s): The following urodynamic parameters/assessments will be used to assess the treatment efficacy: • Change from baseline in Pdet, Qmax (detrusor pressure at maximum flow rate) • Change from baseline in Qmax • Change from baseline in Cystometric capacity • Change from baseline in post-void residual urine volume (PVR) • Change from baseline in Qave (average flow rate = volume voided/flow time) • Change from baseline in volume at first unstable contraction • Change from baseline in average detrusor pressure during micturition Subjects will be asked to complete the “one week” version of the IPSS at Screening, prior to each treatment period and end of each treatment period. From the IPSS, the following endpoints will be derived and analyzed: • the change in the IPSS total score: sum of the IPSS questions 1-7; • the change in the IPSS storage subscore: sum of the IPSS questions 2, 4 and 7; • the change in the IPSS voiding subscore: sum of the IPSS questions 1, 3, 5 and 6. Where the change will be calculated as the difference in the specified score between thebaseline and end of treatment for each period. • Change from baseline in BOOI (bladder outlet obstruction index= Pdet,Qmax –2Qmax; formerly the AG number) • Change from baseline in BCI (bladder contractility index= Pdet,Qmax +5Qmax) • Change from baseline in BE (Bladder voiding efficiency= (Voided volume/total bladder capacity) X 100) The change from baseline for each endpoint during each period will be calculated by using the baseline value for that endpoint that was measured prior to period. | — |
Countries
Czech Republic, Latvia, Netherlands
Outcome results
None listed