PERMIN: 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)

Sponsor

Pierre Fabre Medicament (Industry)

Overall Status

Completed

CT.gov ID

NCT01604811

Collaborator

(none)

206

Enrollment

Locations

Arms

Duration (Months)

6.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

206 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Jun 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Change from baseline of Inflammation Biomarkers [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) "

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 85 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	City	Country
1	Angers	France
2	Bordeaux	France
3	Cornebarrieu	France
4	Creteil	France
5	La Tronche	France
6	Le Fousseret	France
7	Limoges	France
8	Lyon	France
9	Marseille	France
10	Nice	France
11	Paris	France
12	Saint Orens de Gameville	France
13	Segre	France
14	Seysses	France
15	Tierce	France
16	Toulouse	France
17	Bari	Italy
18	Catanzaro	Italy
19	Firenze	Italy
20	Genova	Italy
21	Milano	Italy
22	Perugia	Italy
23	Pisa	Italy
24	Trieste	Italy
25	Lisboa	Portugal
26	Porto	Portugal
27	A.Coruna	Spain
28	Barcelona	Spain
29	Bilbao	Spain
30	Madrid	Spain
31	Sabadell	Spain
32	Sevilla	Spain