Back to resultsPERmixon® in LUTS Evaluation Study (PERLES) (PERLES)
Primary Purpose
Benign Prostatic Hyperplasia (BPH)
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Permixon® 160 mg
Tamsulosine LP
Placebo matching Permixon® 160 mg
Placebo matching Tamsulosine LP
Sponsored by
About this trial
This is an interventional treatment trial for Benign Prostatic Hyperplasia (BPH)
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Other
Arm Label
Permixon® 160 mg & Placebo
Placebo
Tamsulosine LP & Placebo
Arm Description
Active control arm
Outcomes
Primary Outcome Measures
International Prostate Symptom Score (I-PSS score) change
I-PSS score change from baseline to D180
Secondary Outcome Measures
Full Information
NCT ID
NCT02121613
First Posted
April 18, 2014
Last Updated
September 1, 2016
Sponsor
Pierre Fabre Medicament
1. Study Identification
Unique Protocol Identification Number
NCT02121613
Brief Title
PERmixon® in LUTS Evaluation Study (PERLES)
Acronym
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
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament
4. Oversight
5. Study Description
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.
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
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
833 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Permixon® 160 mg & Placebo
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Tamsulosine LP & Placebo
Arm Type
Other
Arm Description
Active control arm
Intervention Type
Drug
Intervention Name(s)
Permixon® 160 mg
Intervention Description
Oral administration - 160 mg twice daily.
Intervention Type
Drug
Intervention Name(s)
Tamsulosine 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 LP
Intervention Description
Oral administration - daily.
Primary Outcome Measure Information:
Title
International Prostate Symptom Score (I-PSS score) change
Description
I-PSS score change from baseline to D180
Time Frame
Day 180
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Keddad, MD
Organizational Affiliation
Pierre Fabre Medicament
Official's Role
Study Director
Facility Information:
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
12. IPD Sharing Statement
Learn more about this trial
PERmixon® in LUTS Evaluation Study (PERLES)
We'll reach out to this number within 24 hrs