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AzTrials

Benign Prostatic Hyperplasia (BPH)Phase 4PERMINNCT01604811

Exploratory Study of L.S.E.S.r. (LipidoSterolic Extract of Serenoa Repens)(PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in Urinary Symptoms Related to BPH (Benign Prostatic Hyperplasia)

A Phase 4 study testing Permixon® 160 mg and Tamsulosine Arrow LP in people with Benign Prostatic Hyperplasia (BPH), run by Pierre Fabre Medicament at 32 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent published works pointed out that urine and serum markers could be used for detection of prostatic inflammation. 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 Arrow LP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
32 sitesin 4 countries
Study dates
Jun 2012to Oct 2013
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 patient
  • Between 45 and 85 years old.
  • Patient with bothersome lower urinary tract symptoms such as pollakiuria (daytime or night time), urgency, sensation of incomplete voiding, delayed urination or weak stream, existing for over 12 months
  • I-PSS ≥ 10 at selection visit and ≥ 12 at randomisation visit (visit 2)
  • Stable patient's disease at randomisation defined as an absolute difference of 2 or less on I-PSS between selection and randomisation visits (visit 1 and visit 2)
  • I-PSS QoL score ≥ 3 evaluated at selection and randomisation visits,
Show all 12Show fewer
  • 5 mL/s ≤ maximum urinary flow rate < 15 mL/s for a voided volume ≥ 150 mL and ≤ 500 mL evaluated at randomisation visit (2 measurements if necessary)
  • Prostatic volume ≥30 cm³ determined by transrectal ultrasound at randomisation visit (visit 2)
  • Serum total PSA at randomisation visit (visit 2) :
  • 4 ng/mL
  • 10 ng/mL and Prostate Specific Antigen (free) / Prostate Specific Antigen (total) ≥ 25% or negative prostate biopsy within the past 6 months prior to selection visit.
  • Patient able to understand and sign the informed consent and understand and fill in self-questionnaires

Who cannot join

  • Post-void residual urine volume > 200 mL (by suprapubic ultrasound) at randomisation visit (visit 2).
  • Urological history :
  • Urethral stricture disease and/or bladder neck disease
  • Active (at selection and randomisation visits) or recent (< 3 months) or recurrent urinary tract infection
  • Indication of BPH surgery
  • Stone in bladder or urethra
Show all 12Show fewer
  • Acute or chronic (documented) prostatitis
  • Prostate and cancer cancer treated or untreated
  • Interstitial cystitis (documented by symptoms and/or biopsy)
  • Active upper tract stone disease causing symptoms
  • Patient with history of surgery of the prostate, bladder neck or pelvic region
  • Any local and/or systemic inflammation disorders at selection and randomisation visit

Trial locations and contacts

32 sites in 4 countries.

32 sites in 4 countries

France16 sites

  • Study site

    Angers

  • Study site

    Bordeaux

  • Study site

    Cornebarrieu

  • Study site

    Créteil

  • Study site

    La Tronche

  • Study site

    Le Fousseret

  • Study site

    Limoges

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Saint-Orens-de-Gameville

  • Study site

    Segré

  • Study site

    Seysses

  • Study site

    Tiercé

  • Study site

    Toulouse

Other trials in France

Italy8 sites

  • Study site

    Bari

  • Study site

    Catanzaro

  • Study site

    Florence

  • Study site

    Genova

  • Study site

    Milan

  • Study site

    Perugia

  • Study site

    Pisa

  • Study site

    Trieste

Other trials in Italy

Spain6 sites

  • Study site

    A.Coruna

  • Study site

    Barcelona

  • Study site

    Bilbao

  • Study site

    Madrid

  • Study site

    Sabadell

  • Study site

    Seville

Other trials in Spain

Portugal2 sites

  • Study site

    Lisbon

  • Study site

    Porto

Other trials in Portugal

About this study

Official title: Exploratory Study of L.S.E.S.r. (PERMIXON® 160 mg Hard Capsule) Versus Tamsulosine LP Activity on Inflammation Biomarkers in the Treatment of Urinary Symptoms Related to BPH; a Multinational, Multicentric, Randomised, Double Blind Parallel-group Prospective Study

Inflammation is reported as one of the most recent hypotheses to explain BPH. Recent published works pointed out that urine and serum markers could be used for detection of prostatic inflammation.

The aim of the study is to assess the activity on inflammation biomarkers (serum and urine inflammation markers) of Permixon® 160 mg hard capsule and Tamsulosine Arrow LP in the treatment of urinary symptoms related to BPH.

The potential links between serum and urinary markers of inflammation and BPH clinical symptoms at baseline and on treatment will be explored.

Being tested
Permixon® 160 mg, Tamsulosine Arrow LP, Placebo matching Permixon® 160 mg, Placebo matching Tamsulosine Arrow 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 Arrow LPDrug

    Oral administration - 0.4 mg daily.

  • Placebo matching Permixon® 160 mgDrug

    Oral administration - twice daily.

  • Placebo matching Tamsulosine Arrow LPDrug

    Oral administration - daily.

Study groups in NCT01604811
Study groupRoleWhat they receive
Tested productExperimentalNot described
Receives: Drug: Permixon® 160 mg; Drug: Placebo matching Tamsulosine Arrow LP
ComparatorActive comparatorNot described
Receives: Drug: Tamsulosine Arrow LP; Drug: Placebo matching Permixon® 160 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline of Inflammation Biomarkers

    "Inflammation biomarkers assay in patients suffering from Benign Prostatic Hyperplasia at Day 1, Day 30 and Day 90 :

    • Urine inflammation markers [mRNA (messenger RiboNucleic Acid) and proteins] on the first urine flow after digital rectal examination
    • Serum inflammation markers (C-Reactive Protein and Sedimentation Rate) "

    Measured: Day 1 (baseline), Day 30, Day 90

Secondary outcomes (7)

  1. Change from baseline of urinary symptoms

    Urinary symptoms assessed by International Prostate Symptom Score (I-PSS) (self-administered questionnaire)

    Measured: Day 1 (baseline), Day 30, Day 90

  2. Change from baseline of quality of life

    Impact of symptoms on quality of life on the basis of the I-PSS quality of life question scored by the patient

    Measured: Day 1 (baseline), Day 30, Day 90

  3. Change from baseline of sexual activity

    Sexual activity assessed by the Male Sexual Function questionnaire (MSF-4) (self-administered questionnaire)

    Measured: Day 1 (baseline), Day 30, Day 90

  4. Change from baseline of maximum urinary flow rate

    Uroflowmetry performed using an electronic flow meter.

    Measured: Day 1 (baseline), Day 30, Day 90

  5. Change from baseline of prostate volume

    Prostate volume determined by transrectal ultrasound

    Measured: Day 1 (baseline), Day 30, Day 90

  6. Change from baseline of post-void residual urine volume (PVR)

    Post-void residual urine volume determined by suprapubic ultrasound.

    Measured: Day 1 (baseline), Day 30, Day 90

  7. Number of adverse events

    Number of adverse events

    Measured: up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01604811
Sponsor's protocol ID
P00048 GP 4 03
Other IDs
2011-005307-33
Acronym
PERMIN
Status last verified
Jul 2013
First submitted
22 May 2012
Last updated
15 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Permixon® 160 mg and Tamsulosine Arrow LP in people with Benign Prostatic Hyperplasia (BPH), run by Pierre Fabre Medicament at 32 sites in 4 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 12 inclusion and 12 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 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in France, Italy, Spain, Portugal. 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. 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?

Change from baseline of Inflammation Biomarkers (time frame: Day 1 (baseline), Day 30, Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01604811.

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 15 Jan 2014.

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