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Completed

NCT Number: NCT02121613

PERmixon® in LUTS Evaluation Study (PERLES)

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.

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Benešov, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Permixon® 160 mg

Drug

Oral administration - 160 mg twice daily.

Tamsulosine LP

Drug

Oral administration - 0.4 mg daily.

Placebo matching Permixon® 160 mg

Drug

Oral administration - twice daily.

Placebo matching Tamsulosine LP

Drug

Oral administration - daily.

Primary outcomes

  1. International Prostate Symptom Score (I-PSS score) change

    Time frame: Day 180

    I-PSS score change from baseline to D180

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

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

Acronym: PERLES

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 23, 2014
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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