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)
Information source: Pierre Fabre Medicament
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia (BPH)
Intervention: Permixon® 160 mg (Drug); Tamsulosine Arrow LP (Drug); Placebo matching Permixon® 160 mg (Drug); Placebo matching Tamsulosine Arrow LP (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Pierre Fabre Medicament
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Primary outcome: Change from baseline of Inflammation Biomarkers
Secondary outcome: Change from baseline of urinary symptomsChange from baseline of quality of life Change from baseline of sexual activity Change from baseline of maximum urinary flow rate Change from baseline of prostate volume Change from baseline of post-void residual urine volume (PVR) Number of adverse events
Eligibility
Minimum age: 45 Years.
Maximum age: 85 Years.
Gender(s): Male.
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
Locations and Contacts
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
Bari, Italy
Catanzaro, Italy
Firenze, Italy
Genova, Italy
Milano, Italy
Perugia, Italy
Pisa, Italy
Trieste, Italy
Lisboa, Portugal
Porto, Portugal
A.Coruna, Spain
Barcelona, Spain
Bilbao, Spain
Madrid, Spain
Sabadell, Spain
Sevilla, Spain
Additional Information
Starting date: June 2012
Last updated: January 14, 2014
|