Exploratory Study of L.S.E.S.r. (LipidoSterolic Extract of Serenoa Repens)(PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in Urinary Symptoms Related to BPH (Benign Prostatic Hyperplasia)
NCT ID: NCT01604811
Last Updated: 2014-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
206 participants
INTERVENTIONAL
2012-06-30
2013-10-31
Brief Summary
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The aim of the study is to assess the activity on inflammation biomarkers (serum and urine inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the treatment of urinary symptoms related to BPH.
The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Tested product
Permixon® 160 mg
Oral administration - 160 mg twice daily.
Placebo matching Tamsulosine Arrow LP
Oral administration - daily.
Comparator
Tamsulosine Arrow LP
Oral administration - 0.4 mg daily.
Placebo matching Permixon® 160 mg
Oral administration - twice daily.
Interventions
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Permixon® 160 mg
Oral administration - 160 mg twice daily.
Tamsulosine Arrow LP
Oral administration - 0.4 mg daily.
Placebo matching Permixon® 160 mg
Oral administration - twice daily.
Placebo matching Tamsulosine Arrow LP
Oral administration - daily.
Eligibility Criteria
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Inclusion Criteria
* 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) :
* 4 ng/mL
* 10 ng/mL and Prostate Specific Antigen (free) / Prostate Specific Antigen (total) ≥ 25% or negative prostate biopsy within the past 6 months prior to selection visit.
* Patient able to understand and sign the informed consent and understand and fill in self-questionnaires
Exclusion Criteria
* 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
* Indication of BPH surgery
* Stone in bladder or urethra
* Acute or chronic (documented) prostatitis
* Prostate and cancer cancer treated or untreated
* 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
45 Years
85 Years
MALE
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Locations
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Angers, , France
Bordeaux, , France
Cornebarrieu, , France
Créteil, , France
La Tronche, , France
Le Fousseret, , France
Limoges, , France
Lyon, , France
Marseille, , France
Nice, , France
Paris, , France
Saint-Orens-de-Gameville, , France
Segré, , France
Seysses, , France
Tiercé, , France
Toulouse, , France
Bari, , Italy
Catanzaro, , Italy
Florence, , Italy
Genova, , Italy
Milan, , Italy
Perugia, , Italy
Pisa, , Italy
Trieste, , Italy
Lisbon, , Portugal
Porto, , Portugal
A.Coruna, , Spain
Barcelona, , Spain
Bilbao, , Spain
Madrid, , Spain
Sabadell, , Spain
Seville, , Spain
Countries
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Other Identifiers
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2011-005307-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
P00048 GP 4 03
Identifier Type: -
Identifier Source: org_study_id
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