PERmixon® in LUTS Evaluation Study (PERLES) (PERLES)

PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

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.

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia (BPH)
• Intervention / Treatment: Drug: Permixon® 160 mg; Drug: Placebo matching Permixon® 160 mg; Drug: Placebo matching Tamsulosine LP; Drug: Tamsulosine LP

• Study Type: Interventional
• Enrollment (Actual): 833
• Phase: Phase 4

Contacts and Locations

Study Locations

• Czech Republic
  • Benesov, Czech Republic
  • Litomerice, Czech Republic
  • Plzen, Czech Republic
  • Praha, Czech Republic
  • Roudnice nad Labem, Czech Republic
  • Sternberk, Czech Republic
  • Usti nad Labem, Czech Republic
• France
  • Angers, France
  • Creteil, France
  • Limoges, France
  • Lyon, France
  • Marseille, France
  • Montreuil Juigne, France
  • Nice, France
  • Nieul sur mer, France
  • Paris, France
  • Saint Orens de Gameville, France
  • Seysses, France
  • Tierce, France
• Germany
  • Berlin, Germany
  • Hagenow, Germany
  • Halle, Germany
  • Hamburg, Germany
  • Herzogenaurach, Germany
  • Hettstedt, Germany
  • Leipzig, Germany
  • Markkleeberg, Germany
  • Michelstadt, Germany
  • Mülheim, Germany
  • Nürnberg, Germany
  • Regensburg, Germany
• Italy
  • Bari, Italy
  • Catanzaro, Italy
  • Foggia, Italy
  • Messina, Italy
  • Milano, Italy
  • Napoli, Italy
  • Novara, Italy
  • Orbassano, Italy
  • Padova, Italy
  • Palermo, Italy
  • Pesaro, Italy
  • Pietra Ligure, Italy
  • Prato, Italy
  • Roma, Italy
  • Udine, Italy
• Spain
  • Barcelona, Spain
  • Coslada, Spain
  • El Palmar Murcia, Spain
  • Figueres, Spain
  • Getafe, Spain
  • Madrid, Spain
  • Parla, Spain
  • Sabadell, Spain
  • Salamanca, Spain
  • San sebastian de los Reyes, Spain
  • Sevilla, Spain
  • Ultrera, Spain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo matching Permixon® 160 mg; Oral administration - twice daily.; Drug: Placebo matching Tamsulosine LP; Oral administration - daily.
Experimental: Permixon® 160 mg & Placebo	Drug: Permixon® 160 mg; Oral administration - 160 mg twice daily.; Drug: Placebo matching Permixon® 160 mg; Oral administration - twice daily.; Drug: Placebo matching Tamsulosine LP; Oral administration - daily.
Other: Tamsulosine LP & Placebo; Active control arm	Drug: Placebo matching Permixon® 160 mg; Oral administration - twice daily.; Drug: Placebo matching Tamsulosine LP; Oral administration - daily.; Drug: Tamsulosine LP; Oral administration - 0.4 mg daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symptom Score (I-PSS score) change	I-PSS score change from baseline to D180	Day 180

Collaborators and Investigators

• Sponsor: Pierre Fabre Medicament

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 18, 2014
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Estimate): September 2, 2016
• Last Update Submitted That Met QC Criteria: September 1, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin; Saw palmetto extract
• Other Study ID Numbers: P00048 GP 4 04; 2014-000222-38 (EudraCT Number)