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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)

Information source: Pierre Fabre Medicament
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Benign Prostatic Hyperplasia (BPH)

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

Phase: Phase 4

Status: Completed

Sponsored by: Pierre Fabre Medicament

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.

Clinical Details

Official title: 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; a Multinational, Multicentric, Randomised, Double Blind Parallel-group Prospective Study

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Primary outcome: Change from baseline of Inflammation Biomarkers

Secondary outcome:

Change from baseline of urinary symptoms

Change from baseline of quality of life

Change from baseline of sexual activity

Change from baseline of maximum urinary flow rate

Change from baseline of prostate volume

Change from baseline of post-void residual urine volume (PVR)

Number of adverse events

Eligibility

Minimum age: 45 Years. Maximum age: 85 Years. Gender(s): Male.

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 < 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:

- 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

Locations and Contacts

Angers, France

Bordeaux, France

Cornebarrieu, France

Creteil, France

La Tronche, France

Le Fousseret, France

Limoges, France

Lyon, France

Marseille, France

Nice, France

Paris, France

Saint Orens de Gameville, France

Segre, France

Seysses, France

Tierce, France

Toulouse, France

Bari, Italy

Catanzaro, Italy

Firenze, Italy

Genova, Italy

Milano, Italy

Perugia, Italy

Pisa, Italy

Trieste, Italy

Lisboa, Portugal

Porto, Portugal

A.Coruna, Spain

Barcelona, Spain

Bilbao, Spain

Madrid, Spain

Sabadell, Spain

Sevilla, Spain

Additional Information

Starting date: June 2012
Last updated: January 14, 2014

Page last updated: August 20, 2015

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