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
2 other identifiers
interventional
833
5 countries
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2014
Typical duration for phase_4
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 18, 2014
CompletedFirst Posted
Study publicly available on registry
April 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedSeptember 2, 2016
September 1, 2016
2.2 years
April 18, 2014
September 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
International Prostate Symptom Score (I-PSS score) change
I-PSS score change from baseline to D180
Day 180
Study Arms (3)
Permixon® 160 mg & Placebo
EXPERIMENTALPlacebo
PLACEBO COMPARATORTamsulosine LP & Placebo
OTHERActive control arm
Interventions
Oral administration - twice daily.
Oral administration - daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Known hypersensitivity to one of the constituents of the study drugs
- Is participating in another clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Unknown Facility
Benešov, Czechia
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Litoměřice, Czechia
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Pilsen, Czechia
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Prague, Czechia
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Roudnice nad Labem, Czechia
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Sternberk, Czechia
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Ústí nad Labem, Czechia
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Angers, France
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Créteil, France
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Limoges, France
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Lyon, France
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Marseille, France
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Montreuil-Juigné, France
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Nice, France
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Nieul-sur-Mer, France
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Paris, France
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Saint-Orens-de-Gameville, France
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Seysses, France
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Tiercé, France
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Berlin, Germany
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Hagenow, Germany
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Halle, Germany
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Hamburg, Germany
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Herzogenaurach, Germany
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Hettstedt, Germany
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Leipzig, Germany
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Markkleeberg, Germany
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Michelstadt, Germany
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Mülheim, Germany
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Nuremberg, Germany
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Regensburg, Germany
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Bari, Italy
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Catanzaro, Italy
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Foggia, Italy
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Messina, Italy
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Milan, Italy
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Napoli, Italy
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Novara, Italy
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Orbassano, Italy
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Padua, Italy
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Palermo, Italy
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Pesaro, Italy
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Pietra Ligure, Italy
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Prato, Italy
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Roma, Italy
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Udine, Italy
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Barcelona, Spain
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Coslada, Spain
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El Palmar Murcia, Spain
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Figueres, Spain
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Getafe, Spain
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Madrid, Spain
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Parla, Spain
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Sabadell, Spain
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Salamanca, Spain
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San Sebastián de los Reyes, Spain
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Seville, Spain
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Utrera de la Encomienda, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Karim Keddad, MD
Pierre Fabre Medicament
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2014
First Posted
April 23, 2014
Study Start
April 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
September 2, 2016
Record last verified: 2016-09