PERmixon® in LUTS Evaluation Study (PERLES)

Pierre Fabre

Status and phase: Completed; Phase 4

Conditions: Benign Prostatic Hyperplasia (BPH)

Treatments: Drug: Placebo matching Permixon® 160 mg; Drug: Tamsulosine LP; Drug: Permixon® 160 mg; Drug: Placebo matching Tamsulosine LP

Study type: Interventional

Funder types: Industry

Identifiers

NCT02121613

2014-000222-38 (EudraCT Number)

P00048 GP 4 04

Details and patient eligibility

About

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.

Enrollment: 833 patients

Sex: Male

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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833 participants in 3 patient groups, including a placebo group

Permixon® 160 mg & Placebo

Experimental group

Treatment:

Drug: Placebo matching Tamsulosine LP

Drug: Permixon® 160 mg

Drug: Placebo matching Permixon® 160 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo matching Tamsulosine LP

Drug: Placebo matching Permixon® 160 mg

Tamsulosine LP & Placebo

Other group

Description:

Active control arm

Treatment:

Drug: Tamsulosine LP

Drug: Placebo matching Tamsulosine LP

Drug: Placebo matching Permixon® 160 mg