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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) (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

May 22, 2012
January 14, 2014
June 2012
October 2013   (final data collection date for primary outcome measure)
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) "
Same as current
Complete list of historical versions of study NCT01604811 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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)
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Benign Prostatic Hyperplasia (BPH)
  • Drug: Permixon® 160 mg
    Oral administration - 160 mg twice daily.
  • Drug: Tamsulosine Arrow LP
    Oral administration - 0.4 mg daily.
  • Drug: Placebo matching Permixon® 160 mg
    Oral administration - twice daily.
  • Drug: Placebo matching Tamsulosine Arrow LP
    Oral administration - daily.
  • Experimental: Tested product
    Interventions:
    • Drug: Permixon® 160 mg
    • Drug: Placebo matching Tamsulosine Arrow LP
  • Active Comparator: Comparator
    Interventions:
    • Drug: Tamsulosine Arrow LP
    • Drug: Placebo matching Permixon® 160 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Male
45 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy,   Portugal,   Spain
 
NCT01604811
P00048 GP 4 03, 2011-005307-33
Not Provided
Pierre Fabre Medicament
Pierre Fabre Medicament
Not Provided
Not Provided
Pierre Fabre Medicament
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP