Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008796

Trial Description

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Title

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

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Trial Acronym

PERLES

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URL of the Trial

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Brief Summary in Lay Language

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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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00008796
  •   2015/06/23
  •   2014/04/18
  •   no
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Secondary IDs

  •   2014-000222-38 
  •   NCT02121613  (ClinicalTrials.gov)
  •   P00048 GP 4 04  (Pierre Fabre Medicament)
  •   2014-000222-38 
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Health Condition or Problem studied

  •   Benign Prostatic Hyperplasia (BPH)
  •   N40 -  Hyperplasia of prostate
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Interventions/Observational Groups

  •   Drug: Permixon® 160 mg
  •   Drug: Tamsulosine LP
  •   Drug: Placebo matching Permixon® 160 mg
  •   Drug: Placebo matching Tamsulosine LP
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo, Other
  •   Treatment
  •   Parallel
  •   IV
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Primary Outcome

- International Prostate Symptom Score (I-PSS score) change; time frame: Day 180; I-PSS score change from baseline to D180

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Secondary Outcome

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Countries of Recruitment

  •   Czech Republic
  •   France
  •   Germany
  •   Italy
  •   Spain
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Locations of Recruitment

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Recruitment

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  •   2014/04/30
  •   900
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Male
  •   45   Years
  •   85   Years
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Pierre Fabre Medicament
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    • Pierre Fabre Medicament
    • Athmane BOUROUBI, MD 
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    • Pierre Fabre Medicament
    • Athmane BOUROUBI, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.