Benign Prostatic Hypertrophy With Outflow ObstructionOdyliresinNCT02977832
Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
A study testing Odyliresin and Alfuzosin in people with Benign Prostatic Hypertrophy With Outflow Obstruction and Benign Prostatic Hyperplasia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume, improving the patient's quality of life and eventually limiting the number of patients who require surgery or endoscopy after medical… Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hypertrophy With Outflow Obstruction, Benign Prostatic Hyperplasia
- What is being tested?
- Odyliresin and Alfuzosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2015to Sep 2016
- Phase
- Interventional
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 years of age or older
- Clinically diagnosed with mild to moderate BPH
- Prostatic volume ≥ 30 ml determined by transrectal ultrasound
- Maximum flow rate (Qmax) < 15 ml/sec for a voided volume 150-500 ml
Who cannot join
- Participants must not have severe BPH (IPSS symptom score >21)
- Participants should not be currently undergoing any other form of medical therapy for BPH (5-PDE inhibitors, mepartricine, plant extracts such as Saw Palmetto, vitamin E, and quercetin).
- Patients must not have undergone prior transurethral resection of the prostate (TURP).
- Post void residual (PVD) > 200 ml
- Previous urological history including urethral stricture disease and/or bladder neck disease, urinary retention, bladder stone, chronic prostatitis, bladder cancer, interstitial cystitis, active upper tract stone disease causing symptoms, insulin-dependent diabetes mellitus and non-controlled non-insulin-dependent diabetes mellitus, chronic renal failure
Trial locations and contacts
1 site in 1 country.
Italy1 site
Urology Department Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
About this study
Official title: A Pilot Study of Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume, improving the patient's quality of life and eventually limiting the number of patients who require surgery or endoscopy after medical treatment.
Read the detailed description
The aim of this phase II open clinical trial was to determine if Odyliresin, given its unique chemical structure, has a therapeutic effect on BPH-related LUTS, so as to reduce symptoms, prostate volume, improve the patient's quality of life and eventually to limit number of patients who require surgery or endoscopy after medical treatment. To this aim, patients who seek specialist advice for LUTS with no previous surgical treatment for BPH have been selected for treatment with Odyliresin in addition to an alpha-antagonist, in order determine whether at 12 months a clinical result is obtained, if after 6 and 12 months BPH symptoms are significantly improved, and a reduction of prostatic volume can be observed, thus changing the usual course of the disease. All patients with BPH-related LUTS received both alphalitic and Odyliresin treatment, clinical parameters and uroflowmetry parameters significantly improved, adenoma volume and post-void residual volume were significantly reduced at 12 month. This is the first clinical experience with Iresine Celosia in BPH.
- Being tested
- Odyliresin, Alfuzosin
- Keywords
- LUTS, Iresine celosia, Odyliresin, medical therapy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OdyliresinDietary supplement
Also called Iresine Celosia
Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)
AlfuzosinDrug
Also called alphalytic
10Mg Oral Tablet, Extended Release
| Study group | Role | What they receive |
|---|---|---|
| odyliresin | Experimental | Odyliresin (Iresine celosia) 2 ml Receives: Dietary Supplement: Odyliresin; Drug: Alfuzosin |
| alphalytic | Experimental | alpha-antagonist (alfuzosin 10 mg) Receives: Dietary Supplement: Odyliresin; Drug: Alfuzosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Symptom Score
Measured: 12 months
Secondary outcomes (6)
Maximum flow rate
Measured: 12 months
Average flow rate
Measured: 12 months
Adenoma volume
Measured: 12 months
Residual urine volume
Measured: 12 months
adverse events
Measured: 12 months
Quality of life score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic Hypertrophy With Outflow ObstructionStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Porru, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Carmine Tinelli, MD, Study chair, Ethics Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977832
- Sponsor's protocol ID
- IRCCSPSM
- Acronym
- Odyliresin
- Status last verified
- Feb 2017
- First submitted
- 28 Nov 2016
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Edwards JL. Diagnosis and management of benign prostatic hyperplasia. Am Fam Physician. 2008 May 15;77(10):1403-10.
PubMed 18533373
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02977832
- Acronym / sponsor ID
- Odyliresin / IRCCSPSM
- Keywords
- LUTS, Iresine celosia, Odyliresin, medical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Nov 2016 (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.
Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume, improving the patient's quality of life and eventually limiting the number of patients who require surgery or endoscopy after medical treatment.
Detailed description
The aim of this phase II open clinical trial was to determine if Odyliresin, given its unique chemical structure, has a therapeutic effect on BPH-related LUTS, so as to reduce symptoms, prostate volume, improve the patient's quality of life and eventually to limit number of patients who require surgery or endoscopy after medical treatment. To this aim, patients who seek specialist advice for LUTS with no previous surgical treatment for BPH have been selected for treatment with Odyliresin in addition to an alpha-antagonist, in order determine whether at 12 months a clinical result is obtained, if after 6 and 12 months BPH symptoms are significantly improved, and a reduction of prostatic volume can be observed, thus changing the usual course of the disease. All patients with BPH-related LUTS received both alphalitic and Odyliresin treatment, clinical parameters and uroflowmetry parameters significantly improved, adenoma volume and post-void residual volume were significantly reduced at 12 month. This is the first clinical experience with Iresine Celosia in BPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.
| Arm | Type | Receives |
|---|---|---|
| odyliresin | Experimental | Dietary Supplement: Odyliresin, Drug: AlfuzosinOdyliresin (Iresine celosia) 2 ml |
| alphalytic | Experimental | Dietary Supplement: Odyliresin, Drug: Alfuzosinalpha-antagonist (alfuzosin 10 mg) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 45 years of age or older
- Clinically diagnosed with mild to moderate BPH
- Prostatic volume ≥ 30 ml determined by transrectal ultrasound
- Maximum flow rate (Qmax) < 15 ml/sec for a voided volume 150-500 ml
Key exclusion criteria (5 listed)
- Participants must not have severe BPH (IPSS symptom score >21)
- Participants should not be currently undergoing any other form of medical therapy for BPH (5-PDE inhibitors, mepartricine, plant extracts such as Saw Palmetto, vitamin E, and quercetin).
- Patients must not have undergone prior transurethral resection of the prostate (TURP).
- Post void residual (PVD) > 200 ml
- Previous urological history including urethral stricture disease and/or bladder neck disease, urinary retention, bladder stone, chronic prostatitis, bladder cancer, interstitial cystitis, active upper tract stone disease causing symptoms, insulin-dependent diabetes mellitus and non-controlled non-insulin-dependent diabetes mellitus, chronic renal failure
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 |
|---|---|---|
| OdyliresinAlso: Iresine CelosiaOdyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg) | Dietary supplement | alphalytic, odyliresin |
| AlfuzosinAlso: alphalytic10Mg Oral Tablet, Extended Release | Drug | alphalytic, odyliresin |
Primary outcome
International Prostate Symptom Score
Time frame: 12 months
6 secondary outcomes
Maximum flow rate
Time frame: 12 months
Average flow rate
Time frame: 12 months
Adenoma volume
Time frame: 12 months
Residual urine volume
Time frame: 12 months
adverse events
Time frame: 12 months
Quality of life score
Time frame: 12 months
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 28 Feb 2017.
- Background: PubMed 18533373Edwards JL. Diagnosis and management of benign prostatic hyperplasia. Am Fam Physician. 2008 May 15;77(10):1403-10.
- Individual participant dataSharing planned: Undecided
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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.
Carmine Tinelli, MD study chair
Ethics Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Odyliresin and Alfuzosin in people with Benign Prostatic Hypertrophy With Outflow Obstruction and Benign Prostatic Hyperplasia, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 4 inclusion and 5 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
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 (time frame: 12 months). 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 NCT02977832, which also lists 1 linked publication.
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 28 Feb 2017.