PERmixon® in LUTS Evaluation Study (PERLES)

Benign Prostatic Hyperplasia (BPH) Clinical Trial

— PERLES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121613
• Other study ID #: P00048 GP 4 04
• Secondary ID: 2014-000222-38
• Status: Completed
• Phase: Phase 4
• First received: April 18, 2014
• Last updated: September 1, 2016
• Start date: April 2014
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesItaly: The Italian Medicines AgencyItaly: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Ethics CommitteeGermany: Federal Institute for Drugs and Medical DevicesGermany: Ethics CommitteeCzech Republic: State Institute for Drug ControlCzech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 833
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia (BPH)
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Drug:
• Permixon® 160 mg
Oral administration - 160 mg twice daily.
• Tamsulosine LP
Oral administration - 0.4 mg daily.
• Placebo matching Permixon® 160 mg
Oral administration - twice daily.
• Placebo matching Tamsulosine LP
Oral administration - daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

Czech Republic,  France,  Germany,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Prostate Symptom Score (I-PSS score) change	I-PSS score change from baseline to D180	Day 180	No