Chronic ProstatitisPhase 3NCT03629769
Effects of Proxelan Somministration in Patients With Chronic Prostatitis
A Phase 3 study testing Proxelan in people with Chronic Prostatitis and Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by University of Pisa at 1 site in Italy.
Trial summary
The purpose of the study is to determinate the antinflammatory effects of the Proxelan on a cohort of patients affected by prostatitis'like symptoms and clinical evidence of abacterical prostatistis, trough a significative improvements of pain symptoms according to the NIH-CPSI questionnaire items, spermatozoa… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Chronic Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Premature Ejaculation
- What is being tested?
- Proxelan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 16 Feb 2017to 30 Sep 2018
- Phase
- Phase 3
- 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 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- prostatitis like symptoms for at least three months
Who cannot join
- significant post-voidal residual volume
- Meares and Stamey test suggestive for bacterial infection
- neoplasms,
- urinary stones,
- antibiotic therapy in the previous three months,
- irritable bowel syndrome,
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- previous radiotherapic or chemiotherapic treatment,
- urethral stenosis,
- neurogenic bladder
- previous prostatic surgery
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUP Ospedale cisanello
Pisa, Tuscany, 56124
Tommaso Di Vico, MD, 3393642655, urologiapisa@gmail.com
About this study
Official title: Effects of Proxelan Somministration in Patients With Chronic Prostatitis Cat. IIa NIH: Pilot Study
The purpose of the study is to determinate the antinflammatory effects of the Proxelan on a cohort of patients affected by prostatitis'like symptoms and clinical evidence of abacterical prostatistis, trough a significative improvements of pain symptoms according to the NIH-CPSI questionnaire items, spermatozoa motility/concentration variations and the semen cytokines level decrease.
- Conditions
- Chronic Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Premature Ejaculation
- Being tested
- Proxelan
- Keywords
- Prostate inflammation, CPS/CPPS, Prostatitis, Proxelan
- Medical subject headings
- Prostatitis, Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProxelanDrug
Administration of one suppository of proxelan once a day for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Patients with prostatitis-like symptoms | Experimental | Cohort of patients with CP/CPPS (abacterial prostatitis) Receives: Drug: Proxelan |
What is being measured
The primary outcome is the main question the study is designed to answer.
National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score
Evaluation of pain symptoms trough NIH-CPS questionnaires' pain items (0-6). Values from 0 to 3 normal/slight symptoms; Values from 3 to 6 moderate symptoms; Values over 6 severe symptoms.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start16 Feb 2017
- Primary completion1 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
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 Chronic ProstatitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Riccardo Bartoletti, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629769
- Sponsor's protocol ID
- 1103 / 2016
- Status last verified
- Aug 2018
- First submitted
- 23 May 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Galeone G, Spadavecchia R, Balducci MT, Pagliarulo V. [The role of Proxelan in the treatment of chronic prostatitis. Results of a randomized trial]. Minerva Urol Nefrol. 2012 Jun;64(2):135-41. Italian.
PubMed 22617307
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proxelan Somministration in Patients With Chronic Prostatitis Cat. IIa NIH: Pilot Study
- ClinicalTrials.gov ID
- NCT03629769
- Acronym / sponsor ID
- 1103 / 2016
- Conditions
- Chronic Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome, Premature Ejaculation
- Keywords
- Prostate inflammation, CPS/CPPS, Prostatitis, Proxelan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 14 Aug 2018 (actual)
- 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 purpose of the study is to determinate the antinflammatory effects of the Proxelan on a cohort of patients affected by prostatitis'like symptoms and clinical evidence of abacterical prostatistis, trough a significative improvements of pain symptoms according to the NIH-CPSI questionnaire items, spermatozoa motility/concentration variations and the semen cytokines level decrease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with prostatitis-like symptoms | Experimental | Drug: ProxelanCohort of patients with CP/CPPS (abacterial prostatitis) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- prostatitis like symptoms for at least three months
Key exclusion criteria (10 listed)
- significant post-voidal residual volume
- Meares and Stamey test suggestive for bacterial infection
- neoplasms,
- urinary stones,
- antibiotic therapy in the previous three months,
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 |
|---|---|---|
| ProxelanAdministration of one suppository of proxelan once a day for 30 days | Drug | Patients with prostatitis-like symptoms |
Primary outcome
National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score
Time frame: 30 days
Evaluation of pain symptoms trough NIH-CPS questionnaires' pain items (0-6). Values from 0 to 3 normal/slight symptoms; Values from 3 to 6 moderate symptoms; Values over 6 severe symptoms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Background: PubMed 22617307Galeone G, Spadavecchia R, Balducci MT, Pagliarulo V. [The role of Proxelan in the treatment of chronic prostatitis. Results of a randomized trial]. Minerva Urol Nefrol. 2012 Jun;64(2):135-41. Italian.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Proxelan in people with Chronic Prostatitis and Chronic Prostatitis With Chronic Pelvic Pain Syndrome, run by University of Pisa 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 1 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Institutes of Health - Chronic Prostatitis Symptom (NIH-CPS) questionnaires score (time frame: 30 days). 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 NCT03629769, 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 14 Aug 2018.