Exploratory study of L.S.E.S.r. (PERMIXON® 160 mg hard capsule) versus Tamsulosine LP activity on inflammation biomarkers in the treatment of urinary symptoms related to BPH.

• Conditions: 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: 14.1Level: LLTClassification code 10004447Term: Benign prostatic hypertrophySystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2011-005307-33-PT
• Lead Sponsor: PIERRE FABRE MEDICAMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-04
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 200

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 < 15 mL/s for a voided volume = 150 mL
and = 500 mL evaluated at randomisation visit (2 measurements if necessary)
- Prostatic volume =30 cm³ determined by transrectal ultrasound at
randomisation visit (visit 2)
- Serum total PSA at randomisation visit (visit 2) :
a) = 4 ng/mL
or
b) = 10 ng/mL and
PSA (free) / PSA (total) = 25% or negative prostate biopsy within the past 6
months prior to selection visit.
Ethical /legal considerations:
- Patient able to understand and sign the informed consent and understand and
fill in self-questionnaires
- Having signed his written informed consent
- Affiliated to a social security system, or is a beneficiary (if applicable in the
national regulation).
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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

Study & Design

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