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)

NCT01604811 | Completed Phase 4

• 2 other identifiers: P00048 GP 4 032011-005307-33
• Study Type: interventional
• Target: 206
• Locations: 4 countries
• Sites: 32

Brief Summary

Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent published works pointed out that urine and serum markers could be used for detection of prostatic inflammation. 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.

Conditions

Benign Prostatic Hyperplasia (BPH)

Outcome Measures

Primary Outcomes (1)

• Change from baseline of Inflammation Biomarkers

  "Inflammation biomarkers assay in patients suffering from Benign Prostatic Hyperplasia at Day 1, Day 30 and Day 90 : * Urine inflammation markers \[mRNA (messenger RiboNucleic Acid) and proteins\] on the first urine flow after digital rectal examination * Serum inflammation markers (C-Reactive Protein and Sedimentation Rate) "

  Day 1 (baseline), Day 30, Day 90

Secondary Outcomes (7)

• Change from baseline of urinary symptoms

  Day 1 (baseline), Day 30, Day 90

• Change from baseline of quality of life

  Day 1 (baseline), Day 30, Day 90

• Change from baseline of sexual activity

  Day 1 (baseline), Day 30, Day 90

• Change from baseline of maximum urinary flow rate

  Day 1 (baseline), Day 30, Day 90

• Change from baseline of prostate volume

  Day 1 (baseline), Day 30, Day 90

Study Arms (2)

Tested product

EXPERIMENTAL

Drug: Permixon® 160 mg; Drug: Placebo matching Tamsulosine Arrow LP

Comparator

ACTIVE COMPARATOR

Drug: Tamsulosine Arrow LP; Drug: Placebo matching Permixon® 160 mg

Interventions

Permixon® 160 mg DRUG

Oral administration - 160 mg twice daily.

Tested product

Tamsulosine Arrow LP DRUG

Oral administration - 0.4 mg daily.

Comparator

Placebo matching Permixon® 160 mg DRUG

Oral administration - twice daily.

Comparator

Placebo matching Tamsulosine Arrow LP DRUG

Oral administration - daily.

Tested product

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• 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) :
• ng/mL
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (32)

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Angers, France

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Bordeaux, France

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Cornebarrieu, France

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Créteil, France

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La Tronche, France

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Le Fousseret, France

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Limoges, France

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Lyon, France

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Marseille, France

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Nice, France

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Paris, France

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Saint-Orens-de-Gameville, France

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Segré, France

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Seysses, France

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Tiercé, France

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Toulouse, France

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Bari, Italy

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Catanzaro, Italy

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Florence, Italy

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Genova, Italy

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Milan, Italy

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Perugia, Italy

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Pisa, Italy

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Trieste, Italy

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Lisbon, Portugal

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Porto, Portugal

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A.Coruna, Spain

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Barcelona, Spain

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Bilbao, Spain

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Madrid, Spain

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Sabadell, Spain

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Seville, Spain

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MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

saw palmetto extract

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: May 24, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 15, 2014

Record last verified: 2013-07

Locations

FR (16); PT (2); ES (6); IT (8)