The aim of the proposed study is to assess the activity on inflammation biomarkers of L.S.E.S.r (PERMIXON® 160mg hard capsule) and Tamsulosine LP in the treatment of BPH. The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored. MedDRA version: 14.1 Level: LLT Classification code 10004447 Term: Benign prostatic hypertrophy System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: PERMIXON 160mg, hard capsule
Product Name: PERMIXON
Product Code: P0048
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: LIPIDOSTEROLIC EXTRACT OF SERENOA REPENS
Current Sponsor co
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Male patient - Between 45 and 85 years old. - Patient with bothersome lower urinary tract symptoms such as pollakiuria (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream, existing for over 12 months - I-PSS = 10 at selection visit and = 12 at randomisation visit (visit 2) - Stable patient’s disease at randomisation defined as an absolute difference of 2 or less on I-PSS between selection and randomisation visits (visit 1 and visit 2) - I-PSS QoL score = 3 evaluated at selection and randomisation visits, - 5 mL/s = maximum urinary flow rate =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Post-void residual urine volume > 200 mL (by suprapubic ultrasound) at randomisation visit (visit 2). - Urological history : Urethral stricture disease and/or bladder neck disease Active (at selection and randomisation visits) or recent (< 3 months) or recurrent urinary tract infection Urinary retention with indwelling catheter or intermittent catheterisation History of unprompted acute urinary retention in the past Indication of BPH surgery Stone in bladder or urethra Acute or chronic (documented) prostatitis Prostate cancer treated or untreated Bladder cancer Interstitial cystitis (documented by symptoms and/or biopsy) Active upper tract stone disease causing symptoms - Patient with history of surgery of the prostate, bladder neck or pelvic region - Any local and/or systemic inflammation disorders at selection and randomisation visit - Any neurologic or psychiatric disease/disorder interfering with detrusor or sphincter muscle - Insulin-dependent diabetes mellitus and non-controlled non insulin-dependent diabetes mellitus - Chronic renal insufficiency, with serum creatinine = 30 % above the upper normal range at randomisation visit (visit 2) - History of severe hepatic failure - Orthostatic hypotension defined as a decrease of at least 20 mmHg in SBP or 10 mmHg in DBP between supine and 2-minute standing positions at selection (visit 1) and randomisation visit (visit 2) - Patient with any severe underlying disease considered as life threatening in the short or medium term - Known hypersensitivity to one of the constituents of the study drugs - Concomitant medication with at selection visit (visit 1) and randomisation visit (visit 2) : Anti-androgens (must be discontinued at least 6 months prior to selection) LH-RH analogues (must be discontinued at least 6 months prior to selection) 5 alpha-reductase inhibitors (must be discontinued at least 3 months prior to selection) Plants extracts used for treatment of LUTS (must be discontinued at least 3 months prior to selection) Alpha blockers and alpha/beta blockers (must be discontinued at least 1 month prior to selection) ACE inhibitors, calcium antagonists, beta blockers or diuretics (except if stable dose and initiated more than 6 weeks prior to selection) NSAIDs by systemic route (except aspirin up to 325 mg/day for cardiovascular prophylaxis) Corticosteroids by systemic route. Antibiotics by systemic route Sympathomimetics, antihistamines, antidepressants (anticholinergic), atropine, antispasmodic drugs, antiparkinsonism drugs, pseudoephedrine, chlorpheniramine, spironolactone, mepartricine - Patient with a history of drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Main objective : To evaluate the effect of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. at D30 and D90 on biomarkers of inflammation in patients suffering from BPH : - Urine inflammation markers on the first urine flow : - Gene (mRNA) expression profile of inflammation in BPH - Protein expression profile of inflammation in BPH of the main expressed genes - Serum inflammation markers : - CRP and Sedimentation Rate ;Secondary Objective: -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. through the assessment of I-PSS. -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. through the assessment of QoL. - To assess the effect of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. on sexual function (MSF-4). -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. through the assessment of Qmax. -To assess the efficacy of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. through the assessment of post-void residual urine volume. -To evaluate the effect of L.S.E.S.r. 160 mg b.i.d. and Tamsulosine LP 0.4 mg o.a.d. on prostate volume. - To perform an exploratory analysis of the link between inflammation biomarkers and BPH clinical symptoms at baseline and on treatment. ;Primary end point(s): Inflammation biomarkers assay in patients suffering from BPH : - Urine inflammation markers (mRNA and proteins) on the first urine flow after digital rectal examination (DRE) at D1, D30 and D90 - Serum inflammation markers at D1, D30 and D90 : - CRP and Sedimentation Rate (at 1 hour & 2 hours) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy criteria : -Assessment of I-PSS at selection, D1, D30 and D90. -Assessment of QoL at selection, D1, D30 and D90. -Assessment of sexual function (MSF-4) at D1, D30 and D90. -Assessment of Qmax at D1, D30 and D90, by uroflowmetry - Assessment of post-void residual urine volume at D1, D30 and D90, by supra-pubic ultrasound - Assessment of prostate volume at D1, D30 and D90, by transrectal ultrasound Safety criteria -Adverse events -Physical examination at selection visit and at each visit including body temperature and weight and height (at selection visit only) -Vital signs at selection visit and at each visit | — |
Countries
France, Italy, Portugal, Spain
Outcome results
None listed