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) (PERMIN)

January 14, 2014 updated by: Pierre Fabre Medicament

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
  • Italy
      • Bari, Italy
      • Catanzaro, Italy
      • Firenze, Italy
      • Genova, Italy
      • Milano, Italy
      • Perugia, Italy
      • Pisa, Italy
      • Trieste, Italy
  • Portugal
      • Lisboa, Portugal
      • Porto, Portugal
  • Spain
      • A.Coruna, Spain
      • Barcelona, Spain
      • Bilbao, Spain
      • Madrid, Spain
      • Sabadell, Spain
      • Sevilla, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Comparator
Drug: Tamsulosine Arrow LP
Oral administration - 0.4 mg daily.
Drug: Placebo matching Permixon® 160 mg
Oral administration - twice daily.
Experimental: Tested product
Drug: Permixon® 160 mg
Oral administration - 160 mg twice daily.
Drug: Placebo matching Tamsulosine Arrow LP
Oral administration - daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Inflammation Biomarkers
Time Frame: Day 1 (baseline), Day 30, Day 90

"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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of urinary symptoms
Time Frame: Day 1 (baseline), Day 30, Day 90
Urinary symptoms assessed by International Prostate Symptom Score (I-PSS) (self-administered questionnaire)
Day 1 (baseline), Day 30, Day 90
Change from baseline of quality of life
Time Frame: Day 1 (baseline), Day 30, Day 90
Impact of symptoms on quality of life on the basis of the I-PSS quality of life question scored by the patient
Day 1 (baseline), Day 30, Day 90
Change from baseline of sexual activity
Time Frame: Day 1 (baseline), Day 30, Day 90
Sexual activity assessed by the Male Sexual Function questionnaire (MSF-4) (self-administered questionnaire)
Day 1 (baseline), Day 30, Day 90
Change from baseline of maximum urinary flow rate
Time Frame: Day 1 (baseline), Day 30, Day 90
Uroflowmetry performed using an electronic flow meter.
Day 1 (baseline), Day 30, Day 90
Change from baseline of prostate volume
Time Frame: Day 1 (baseline), Day 30, Day 90
Prostate volume determined by transrectal ultrasound
Day 1 (baseline), Day 30, Day 90
Change from baseline of post-void residual urine volume (PVR)
Time Frame: Day 1 (baseline), Day 30, Day 90
Post-void residual urine volume determined by suprapubic ultrasound.
Day 1 (baseline), Day 30, Day 90
Number of adverse events
Time Frame: up to 90 days
Number of adverse events
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pierre Fabre Medicament

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

May 22, 2012

First Submitted That Met QC Criteria

May 23, 2012

First Posted (Estimate)

May 24, 2012

Study Record Updates

Last Update Posted (Estimate)

January 15, 2014

Last Update Submitted That Met QC Criteria

January 14, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P00048 GP 4 03
  • 2011-005307-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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