Clinical trial NCT02121613: PERmixon® in LUTS Evaluation Study (PERLES)
Official title: PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia (BPH)
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2014-04-23
Enrollment: 833
Sex: MALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to support the efficacy of Permixon 160 mg b.i.d. in treating subjects with symptomatic Benign Prostatic Hyperplasia (BPH), compared to placebo, using Tamsulosine LP 0.4 mg as a reference treatment.


Eligibility criteria: Inclusion Criteria:

* Male subject
* Between 45 and 85 years old
* Subject with bothersome lower urinary tract symptoms (LUTS) due to BPH such as frequency (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream
* Subject naive to any prior treatment for LUTS due to BPH
* Prostate enlargement at digital rectal examination (DRE) suggestive of BPH
* I-PSS \> 12 at enrolment visit and at inclusion visit
* QoL I-PSS score ≥ 3 evaluated at enrolment visit and at inclusion visit

Exclusion Criteria:

* Urological history such as urethral stricture disease and/or bladder neck disease, active (at enrolment and/or inclusion or recurrent urinary tract infection, stone in bladder or urethra)
* Any neurologic or psychiatric disease/disorder interfering with detrusor or sphincter muscle
* Insulin-dependent diabetes mellitus and non-controlled non insulin-dependent diabetes mellitus
* Known severe renal insufficiency or creatinine clearance \< 30 ml/mn
* Known liver insufficiency or clinically significant abnormal liver function tests
* History of, or concomitant, cardiac arrhythmia or angina pectoris
* Orthostatic hypotension at enrolment or inclusion visit
* Known hypersensitivity to one of the constituents of the study drugs
* Is participating in another clinical trial

Primary outcomes:
measure: International Prostate Symptom Score (I-PSS score) change
timeFrame: Day 180
Secondary outcomes:
Other outcomes:
Locations:
city: Benesov
country: Czech Republic
city: Litomerice
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha
country: Czech Republic
city: Roudnice nad Labem
country: Czech Republic
city: Sternberk
country: Czech Republic
city: Usti nad Labem
country: Czech Republic
city: Angers
country: France
city: Creteil
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montreuil Juigne
country: France
city: Nice
country: France
city: Nieul sur mer
country: France
city: Paris
country: France
city: Saint Orens de Gameville
country: France
city: Seysses
country: France
city: Tierce
country: France
city: Berlin
country: Germany
city: Hagenow
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Herzogenaurach
country: Germany
city: Hettstedt
country: Germany
city: Leipzig
country: Germany
city: Markkleeberg
country: Germany
city: Michelstadt
country: Germany
city: Mülheim
country: Germany
city: Nürnberg
country: Germany
city: Regensburg
country: Germany
city: Bari
country: Italy
city: Catanzaro
country: Italy
city: Foggia
country: Italy
city: Messina
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Novara
country: Italy
city: Orbassano
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Pesaro
country: Italy
city: Pietra Ligure
country: Italy
city: Prato
country: Italy
city: Roma
country: Italy
city: Udine
country: Italy
city: Barcelona
country: Spain
city: Coslada
country: Spain
city: El Palmar Murcia
country: Spain
city: Figueres
country: Spain
city: Getafe
country: Spain
city: Madrid
country: Spain
city: Parla
country: Spain
city: Sabadell
country: Spain
city: Salamanca
country: Spain
city: San sebastian de los Reyes
country: Spain
city: Sevilla
country: Spain
city: Ultrera
country: Spain
Study officials:
affiliation: Pierre Fabre Medicament
name: Karim Keddad, MD
role: STUDY_DIRECTOR
References: