Trial document

PLEASE NOTE:
This study has been imported from ClinicalTrials.gov without additional data checks.

drksid header

DRKS-ID: DRKS00008796

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title

start of 1:1-Block acronym

Trial Acronym

PERLES

end of 1:1-Block acronym

start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url

start of 1:1-Block public summary

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.

end of 1:1-Block public summary

start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis

start of 1:1-Block organizational data

Organizational Data

DRKS-ID: DRKS00008796
Date of Registration in DRKS: 2015/06/23
Date of Registration in Partner Registry or other Primary Registry: 2014/04/18
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: [---]*
(leading) Ethics Committee No.: [---]*

end of 1:1-Block organizational data

start of 1:n-Block secondary IDs

Secondary IDs

EudraCT-No. (for studies acc. to Drug Law): 2014-000222-38
Primary Registry-ID: NCT02121613 (ClinicalTrials.gov)
Sponsor-ID: P00048 GP 4 04 (Pierre Fabre Medicament)
Other Secondary-ID: 2014-000222-38

end of 1:n-Block secondary IDs

start of 1:N-Block indications

Health Condition or Problem studied

Free text: Benign Prostatic Hyperplasia (BPH)
ICD10: N40 - Hyperplasia of prostate

end of 1:N-Block indications

start of 1:N-Block interventions

Interventions/Observational Groups

Arm 1: Drug: Permixon® 160 mg
Arm 2: Drug: Tamsulosine LP
Arm 3: Drug: Placebo matching Permixon® 160 mg
Arm 4: Drug: Placebo matching Tamsulosine LP

end of 1:N-Block interventions

start of 1:1-Block design

Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: patient/subject, caregiver, investigator/therapist, assessor
Control: Placebo, Other
Purpose: Treatment
Assignment: Parallel
Phase: IV
Off-label Drug use: [---]*

end of 1:1-Block design

start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint

start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint

start of 1:n-Block recruitment countries

Countries of Recruitment

CZ: Czech Republic
FR: France
DE: Germany
IT: Italy
ES: Spain

end of 1:n-Block recruitment countries

start of 1:n-Block recruitment locations

Locations of Recruitment

Berlin
Hagenow
Halle
Hamburg
Herzogenaurach
Hettstedt
Leipzig
Markkleeberg
Michelstadt
Mülheim
Nürnberg
Regensburg

end of 1:n-Block recruitment locations

start of 1:1-Block recruitment

Recruitment

Planned/Actual: [---]*
(Anticipated or Actual) Date of First Enrollment: 2014/04/30
Target Sample Size: 900
Monocenter/Multicenter trial: Multicenter trial
National/International: International

end of 1:1-Block recruitment

start of 1:1-Block inclusion criteria

Inclusion Criteria

Gender: Male
Minimum Age: 45 Years
Maximum Age: 85 Years

end of 1:1-Block inclusion criteria

start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add

start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria

start of 1:n-Block addresses

Addresses

Primary Sponsor
start of 1:1-Block address primary-sponsor
- Pierre Fabre Medicament
end of 1:1-Block address primary-sponsor

start of 1:1-Block address contact primary-sponsor
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
end of 1:1-Block address contact primary-sponsor
Contact for Scientific Queries
start of 1:1-Block address scientific-contact
- Pierre Fabre Medicament
- Athmane BOUROUBI, MD
end of 1:1-Block address scientific-contact

start of 1:1-Block address contact scientific-contact
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
end of 1:1-Block address contact scientific-contact
Contact for Public Queries
start of 1:1-Block address public-contact
- Pierre Fabre Medicament
- Athmane BOUROUBI, MD
end of 1:1-Block address public-contact

start of 1:1-Block address contact public-contact
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
end of 1:1-Block address contact public-contact

end of 1:n-Block addresses

start of 1:n-Block material support

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 materialSupport

start of 1:1-Block address contact materialSupport
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
end of 1:1-Block address contact materialSupport

end of 1:n-Block material support

start of 1:1-Block state

Status

Recruitment Status: Recruiting complete, follow-up continuing
Study Closing (LPLV): [---]*

end of 1:1-Block state

start of 1:n-Block publications

Trial Publications, Results and other Documents

[---]*

end of 1:n-Block publications

start of 1:n-Block dynamic attributes

Additional Trial Attributes

Urological disease benign prostatic hyperplasia (BPH/BPS)
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 address

start of 1:1-Block address contact
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
end of 1:1-Block address contact
Further contact
start of 1:1-Block address
- [---]*
end of 1:1-Block address

start of 1:1-Block address contact
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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 [---]*

end of 1:n-Block dynamic attributes

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 .

Translation on version: 3
Last processed date by ClinicalTrials.gov: 2016/01/14

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