Prostatic HyperplasiaEarly Phase 1NCT03064282
Prostatic Hyperplasia Treatment and Cancer Prevention
A Early Phase 1 study testing papaverine in people with Prostatic Hyperplasia, run by Manchanda Medical Clinic.
Trial summary
Treatment of patients with prostatic hyperplasia with topical papaverine. Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- papaverine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2021to 1 Dec 2021
- Phase
- Early Phase 1
- 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 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with symptoms e.g. obstructive voiding, hyperplasia and high PSA
Who cannot join
- patients on chemotherapy
- abnormal lab values e.g. liver function, GFR and CAD
About this study
Official title: Treatment of Prostatic Hyperplasia With Topical Papaverine
Treatment of patients with prostatic hyperplasia with topical papaverine.
Read the detailed description
Patients with obstructive voiding and high PSA to be studied for the regression of symptoms and declining PSA.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Placebo, papaverine
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Also called drug free base
observation of skin changes if any
papaverineDrug
observation of symptoms
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Drug free base as placebo Receives: Other: Placebo |
| group two- papaverine arm | Experimental | papaverine in a suitable base Receives: Drug: papaverine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory tests to measure regression of symptoms
patients follow-up on regular intervals
Measured: every 4 weeks up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start30 Jun 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion1 Dec 2021 (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 Prostatic HyperplasiaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manchanda Medical Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR. VINOD C TAWAR, Manchanda Medical Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064282
- Sponsor's protocol ID
- Tawar - 2
- Status last verified
- Feb 2021
- First submitted
- 12 Dec 2016
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hafez B, Hafez ES. Andropause: endocrinology, erectile dysfunction, and prostate pathophysiology. Arch Androl. 2004 Mar-Apr;50(2):45-68.
PubMed 14761837
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Prostatic Hyperplasia With Topical Papaverine
- ClinicalTrials.gov ID
- NCT03064282
- Acronym / sponsor ID
- Tawar - 2
- Conditions
- Prostatic Hyperplasia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Manchanda Medical ClinicUniversity, hospital or other
- Study start
- 30 Jun 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 27 Feb 2017 (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.
Treatment of patients with prostatic hyperplasia with topical papaverine.
Detailed description
Patients with obstructive voiding and high PSA to be studied for the regression of symptoms and declining PSA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboDrug free base as placebo |
| group two- papaverine arm | Experimental | Drug: papaverinepapaverine in a suitable base |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with symptoms e.g. obstructive voiding, hyperplasia and high PSA
Key exclusion criteria (2 listed)
- patients on chemotherapy
- abnormal lab values e.g. liver function, GFR and CAD
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 |
|---|---|---|
| PlaceboAlso: drug free baseobservation of skin changes if any | Other | Placebo |
| papaverineobservation of symptoms | Drug | group two- papaverine arm |
Primary outcome
Laboratory tests to measure regression of symptoms
Time frame: every 4 weeks up to 16 weeks
patients follow-up on regular intervals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Background: PubMed 14761837Hafez B, Hafez ES. Andropause: endocrinology, erectile dysfunction, and prostate pathophysiology. Arch Androl. 2004 Mar-Apr;50(2):45-68.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing papaverine in people with Prostatic Hyperplasia, run by Manchanda Medical Clinic.
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 2 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 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
Laboratory tests to measure regression of symptoms (time frame: every 4 weeks up to 16 weeks). 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 NCT03064282, 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 25 Feb 2021.