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)

Benign Prostatic Hyperplasia (BPH) Clinical Trial

— PERMIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604811
• Other study ID #: P00048 GP 4 03
• Secondary ID: 2011-005307-33
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2012
• Last updated: January 14, 2014
• Start date: June 2012
• Est. completion date: October 2013

Study information

• Verified date: July 2013
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Conseil National de l'Ordre des MédecinsFrance: Agence Nationale de Sécurité du Médicament et des produits de santéItaly: Ethics CommitteeItaly: The Italian Medicines AgencyPortugal: Ethics Committee for Clinical ResearchPortugal: National Pharmacy and Medicines InstituteSpain: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Permixon® 160 mg
Oral administration - 160 mg twice daily.
• Tamsulosine Arrow LP
Oral administration - 0.4 mg daily.
• Placebo matching Permixon® 160 mg
Oral administration - twice daily.
• Placebo matching Tamsulosine Arrow LP
Oral administration - daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

France,  Italy,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline of urinary symptoms	Urinary symptoms assessed by International Prostate Symptom Score (I-PSS) (self-administered questionnaire)	Day 1 (baseline), Day 30, Day 90	No
Secondary	Change from baseline of quality of life	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	No
Secondary	Change from baseline of sexual activity	Sexual activity assessed by the Male Sexual Function questionnaire (MSF-4) (self-administered questionnaire)	Day 1 (baseline), Day 30, Day 90	No
Secondary	Change from baseline of maximum urinary flow rate	Uroflowmetry performed using an electronic flow meter.	Day 1 (baseline), Day 30, Day 90	No
Secondary	Change from baseline of prostate volume	Prostate volume determined by transrectal ultrasound	Day 1 (baseline), Day 30, Day 90	No
Secondary	Change from baseline of post-void residual urine volume (PVR)	Post-void residual urine volume determined by suprapubic ultrasound.	Day 1 (baseline), Day 30, Day 90	No
Secondary	Number of adverse events	Number of adverse events	up to 90 days	Yes