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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT01604811
First received: May 22, 2012
Last updated: January 14, 2014
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia (BPH)
Drug: Permixon® 160 mg
Drug: Tamsulosine Arrow LP
Drug: Placebo matching Permixon® 160 mg
Drug: Placebo matching Tamsulosine Arrow LP
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • Change from baseline of Inflammation Biomarkers [ Time Frame: Day 1 (baseline), Day 30, Day 90 ] [ Designated as safety issue: No ]

    "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) "


Secondary Outcome Measures:
  • Change from baseline of urinary symptoms [ Time Frame: Day 1 (baseline), Day 30, Day 90 ] [ Designated as safety issue: No ]
    Urinary symptoms assessed by International Prostate Symptom Score (I-PSS) (self-administered questionnaire)

  • Change from baseline of quality of life [ Time Frame: Day 1 (baseline), Day 30, Day 90 ] [ Designated as safety issue: No ]
    Impact of symptoms on quality of life on the basis of the I-PSS quality of life question scored by the patient

  • Change from baseline of sexual activity [ Time Frame: Day 1 (baseline), Day 30, Day 90 ] [ Designated as safety issue: No ]
    Sexual activity assessed by the Male Sexual Function questionnaire (MSF-4) (self-administered questionnaire)

  • Change from baseline of maximum urinary flow rate [ Time Frame: Day 1 (baseline), Day 30, Day 90 ] [ Designated as safety issue: No ]
    Uroflowmetry performed using an electronic flow meter.

  • Change from baseline of prostate volume [ Time Frame: Day 1 (baseline), Day 30, Day 90 ] [ Designated as safety issue: No ]
    Prostate volume determined by transrectal ultrasound

  • Change from baseline of post-void residual urine volume (PVR) [ Time Frame: Day 1 (baseline), Day 30, Day 90 ] [ Designated as safety issue: No ]
    Post-void residual urine volume determined by suprapubic ultrasound.

  • Number of adverse events [ Time Frame: up to 90 days ] [ Designated as safety issue: Yes ]
    Number of adverse events


Enrollment: 206
Study Start Date: June 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tested product Drug: Permixon® 160 mg
Oral administration - 160 mg twice daily.
Drug: Placebo matching Tamsulosine Arrow LP
Oral administration - daily.
Active Comparator: Comparator Drug: Tamsulosine Arrow LP
Oral administration - 0.4 mg daily.
Drug: Placebo matching Permixon® 160 mg
Oral administration - twice daily.

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604811

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
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01604811     History of Changes
Other Study ID Numbers: P00048 GP 4 03, 2011-005307-33
Study First Received: May 22, 2012
Last Updated: January 14, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Portugal: Ethics Committee for Clinical Research
Portugal: National Pharmacy and Medicines Institute
Spain: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Inflammation
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Permixon
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Estrogen Antagonists
Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on August 01, 2014