Back to resultsExploratory 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)
Primary Purpose
Benign Prostatic Hyperplasia (BPH)
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Permixon® 160 mg
Tamsulosine Arrow LP
Placebo matching Permixon® 160 mg
Placebo matching Tamsulosine Arrow LP
Sponsored by
About this trial
This is an interventional basic science trial for Benign Prostatic Hyperplasia (BPH)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tested product
Comparator
Arm Description
Outcomes
Primary Outcome Measures
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) "
Secondary Outcome Measures
Change from baseline of urinary symptoms
Urinary symptoms assessed by International Prostate Symptom Score (I-PSS) (self-administered questionnaire)
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
Change from baseline of sexual activity
Sexual activity assessed by the Male Sexual Function questionnaire (MSF-4) (self-administered questionnaire)
Change from baseline of maximum urinary flow rate
Uroflowmetry performed using an electronic flow meter.
Change from baseline of prostate volume
Prostate volume determined by transrectal ultrasound
Change from baseline of post-void residual urine volume (PVR)
Post-void residual urine volume determined by suprapubic ultrasound.
Number of adverse events
Number of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01604811
Brief Title
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)
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia (BPH)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
206 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tested product
Arm Type
Experimental
Arm Title
Comparator
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Permixon® 160 mg
Intervention Description
Oral administration - 160 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Tamsulosine Arrow LP
Intervention Description
Oral administration - 0.4 mg daily.
Intervention Type
Drug
Intervention Name(s)
Placebo matching Permixon® 160 mg
Intervention Description
Oral administration - twice daily.
Intervention Type
Drug
Intervention Name(s)
Placebo matching Tamsulosine Arrow LP
Intervention Description
Oral administration - daily.
Primary Outcome Measure Information:
Title
Change from baseline of Inflammation Biomarkers
Description
"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) "
Time Frame
Day 1 (baseline), Day 30, Day 90
Secondary Outcome Measure Information:
Title
Change from baseline of urinary symptoms
Description
Urinary symptoms assessed by International Prostate Symptom Score (I-PSS) (self-administered questionnaire)
Time Frame
Day 1 (baseline), Day 30, Day 90
Title
Change from baseline of quality of life
Description
Impact of symptoms on quality of life on the basis of the I-PSS quality of life question scored by the patient
Time Frame
Day 1 (baseline), Day 30, Day 90
Title
Change from baseline of sexual activity
Description
Sexual activity assessed by the Male Sexual Function questionnaire (MSF-4) (self-administered questionnaire)
Time Frame
Day 1 (baseline), Day 30, Day 90
Title
Change from baseline of maximum urinary flow rate
Description
Uroflowmetry performed using an electronic flow meter.
Time Frame
Day 1 (baseline), Day 30, Day 90
Title
Change from baseline of prostate volume
Description
Prostate volume determined by transrectal ultrasound
Time Frame
Day 1 (baseline), Day 30, Day 90
Title
Change from baseline of post-void residual urine volume (PVR)
Description
Post-void residual urine volume determined by suprapubic ultrasound.
Time Frame
Day 1 (baseline), Day 30, Day 90
Title
Number of adverse events
Description
Number of adverse events
Time Frame
up to 90 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Angers
Country
France
City
Bordeaux
Country
France
City
Cornebarrieu
Country
France
City
Creteil
Country
France
City
La Tronche
Country
France
City
Le Fousseret
Country
France
City
Limoges
Country
France
City
Lyon
Country
France
City
Marseille
Country
France
City
Nice
Country
France
City
Paris
Country
France
City
Saint Orens de Gameville
Country
France
City
Segre
Country
France
City
Seysses
Country
France
City
Tierce
Country
France
City
Toulouse
Country
France
City
Bari
Country
Italy
City
Catanzaro
Country
Italy
City
Firenze
Country
Italy
City
Genova
Country
Italy
City
Milano
Country
Italy
City
Perugia
Country
Italy
City
Pisa
Country
Italy
City
Trieste
Country
Italy
City
Lisboa
Country
Portugal
City
Porto
Country
Portugal
City
A.Coruna
Country
Spain
City
Barcelona
Country
Spain
City
Bilbao
Country
Spain
City
Madrid
Country
Spain
City
Sabadell
Country
Spain
City
Sevilla
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
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)
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