Benign Prostatic Hyperplasia (BPH)Phase 4PERLESNCT02121613
PERmixon® in LUTS Evaluation Study (PERLES)
A Phase 4 study testing Permixon® 160 mg and Tamsulosine LP in people with Benign Prostatic Hyperplasia (BPH), run by Pierre Fabre Medicament at 58 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Permixon® 160 mg and Tamsulosine LP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 833 participants
- Where
- 58 sitesin 5 countries
- Study dates
- Apr 2014to Jun 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
58 sites in 5 countries.
58 sites in 5 countries
Italy15 sites
Study site
Bari
Study site
Catanzaro
Study site
Foggia
Study site
Messina
Study site
Milan
Study site
Naples
Study site
Novara
Study site
Orbassano
Study site
Padova
Study site
Palermo
Study site
Pesaro
Study site
Pietra Ligure
Study site
Prato
Study site
Roma
Study site
Udine
France12 sites
Study site
Angers
Study site
Créteil
Study site
Limoges
Study site
Lyon
Study site
Marseille
Study site
Montreuil-Juigné
Study site
Nice
Study site
Nieul-sur-Mer
Study site
Paris
Study site
Saint-Orens-de-Gameville
Study site
Seysses
Study site
Tiercé
Germany12 sites
Study site
Berlin
Study site
Hagenow
Study site
Halle
Study site
Hamburg
Study site
Herzogenaurach
Study site
Hettstedt
Study site
Leipzig
Study site
Markkleeberg
Study site
Michelstadt
Study site
Mülheim
Study site
Nuremberg
Study site
Regensburg
Spain12 sites
Study site
Barcelona
Study site
Coslada
Study site
El Palmar Murcia
Study site
Figueres
Study site
Getafe
Study site
Madrid
Study site
Parla
Study site
Sabadell
Study site
Salamanca
Study site
San Sebastián de los Reyes
Study site
Seville
Study site
Utrera de la Encomienda
Czechia7 sites
Study site
Benešov
Study site
Litoměřice
Study site
Pilsen
Study site
Prague
Study site
Roudnice nad Labem
Study site
Sternberk
Study site
Ústí nad Labem
About this study
Official title: PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
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.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- Permixon® 160 mg, Tamsulosine LP, Placebo matching Permixon® 160 mg, Placebo matching Tamsulosine LP
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permixon® 160 mgDrug
Oral administration - 160 mg twice daily.
Tamsulosine LPDrug
Oral administration - 0.4 mg daily.
Placebo matching Permixon® 160 mgDrug
Oral administration - twice daily.
Placebo matching Tamsulosine LPDrug
Oral administration - daily.
| Study group | Role | What they receive |
|---|---|---|
| Permixon® 160 mg & Placebo | Experimental | Not described Receives: Drug: Permixon® 160 mg; Drug: Placebo matching Permixon® 160 mg; Drug: Placebo matching Tamsulosine LP |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo matching Permixon® 160 mg; Drug: Placebo matching Tamsulosine LP |
| Tamsulosine LP & Placebo | Other | Active control arm Receives: Drug: Tamsulosine LP; Drug: Placebo matching Permixon® 160 mg; Drug: Placebo matching Tamsulosine LP |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score (I-PSS score) change
I-PSS score change from baseline to D180
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 833 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karim Keddad, MD, Study director, Pierre Fabre Medicament
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121613
- Sponsor's protocol ID
- P00048 GP 4 04
- Other IDs
- 2014-000222-38, 2014
- Acronym
- PERLES
- Status last verified
- Sep 2016
- First submitted
- 18 Apr 2014
- Last updated
- 2 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERMIXON® 160 mg Hard Capsule Versus Placebo in the Treatment of Symptomatic Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02121613
- Acronym / sponsor ID
- PERLES / P00048 GP 4 04
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 833 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Permixon® 160 mg & Placebo | Experimental | Drug: Permixon® 160 mg, Drug: Placebo matching Permixon® 160 mg, Drug: Placebo matching Tamsulosine LP |
| Placebo | Placebo comparator | Drug: Placebo matching Permixon® 160 mg, Drug: Placebo matching Tamsulosine LP |
| Tamsulosine LP & Placebo | Other | Drug: Tamsulosine LP, Drug: Placebo matching Permixon® 160 mg, Drug: Placebo matching Tamsulosine LPActive control arm |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permixon® 160 mgOral administration - 160 mg twice daily. | Drug | Permixon® 160 mg & Placebo |
| Tamsulosine LPOral administration - 0.4 mg daily. | Drug | Tamsulosine LP & Placebo |
| Placebo matching Permixon® 160 mgOral administration - twice daily. | Drug | Permixon® 160 mg & Placebo, Placebo, Tamsulosine LP & Placebo |
| Placebo matching Tamsulosine LPOral administration - daily. | Drug | Permixon® 160 mg & Placebo, Placebo, Tamsulosine LP & Placebo |
Primary outcome
International Prostate Symptom Score (I-PSS score) change
Time frame: Day 180
I-PSS score change from baseline to D180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim Keddad, MD study director
Pierre Fabre Medicament
58 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Permixon® 160 mg and Tamsulosine LP in people with Benign Prostatic Hyperplasia (BPH), run by Pierre Fabre Medicament at 58 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Italy, France, Germany, Spain, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (I-PSS score) change (time frame: Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.