Trial document
This study has been imported from ClinicalTrials.gov without additional data checks.
DRKS00008796
Trial Description
Title
PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Trial Acronym
PERLES
URL of the Trial
[---]*
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.
Brief Summary in Scientific Language
[---]*
Do you plan to share individual participant data with other researchers?
[---]*
Description IPD sharing plan:
[---]*
Organizational Data
- DRKS00008796
- 2015/06/23
- 2014/04/18
- no
- [---]*
- [---]*
Secondary IDs
- 2014-000222-38
- NCT02121613 (ClinicalTrials.gov)
- P00048 GP 4 04 (Pierre Fabre Medicament)
- 2014-000222-38
Health Condition or Problem studied
- Benign Prostatic Hyperplasia (BPH)
- N40 - Hyperplasia of prostate
Interventions/Observational Groups
- Drug: Permixon® 160 mg
- Drug: Tamsulosine LP
- Drug: Placebo matching Permixon® 160 mg
- Drug: Placebo matching Tamsulosine LP
Characteristics
- Interventional
- [---]*
- Randomized controlled trial
- Blinded
- patient/subject, caregiver, investigator/therapist, assessor
- Placebo, Other
- Treatment
- Parallel
- IV
- [---]*
Primary Outcome
- International Prostate Symptom Score (I-PSS score) change; time frame: Day 180; I-PSS score change from baseline to D180
Secondary Outcome
[---]*
Countries of Recruitment
- Czech Republic
- France
- Germany
- Italy
- Spain
Locations of Recruitment
Recruitment
- [---]*
- 2014/04/30
- 900
- Multicenter trial
- International
Inclusion Criteria
- Male
- 45 Years
- 85 Years
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
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
Addresses
-
start of 1:1-Block address primary-sponsor
- Pierre Fabre Medicament
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Pierre Fabre Medicament
- Athmane BOUROUBI, MD
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Pierre Fabre Medicament
- Athmane BOUROUBI, MD
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting complete, follow-up continuing
- [---]*
Trial Publications, Results and other Documents
- [---]*
Additional Trial Attributes
- Urological disease
- If other, please specify
- Study recommendations
- If other, please specify
- German director of clinical investigation
start of 1:1-Block address
- [---]*
end of 1:1-Block addressstart of 1:1-Block address contact- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact - Further contact
start of 1:1-Block address
- [---]*
end of 1:1-Block addressstart of 1:1-Block address contact- [---]*
- [---]*
- [---]*
- [---]*
end of 1:1-Block address contact - Function of contact
- Non-interventional study
- Stage
- If other, please specify
- Onset of therapy
- If other, please specify
- 3
- 2016/01/14