Prostatic Hyperplasia Treatment and Cancer Prevention | NCT03064282

Studies
Prostatic Hyperplasia Treatment and Cancer Prevention

NCT03064282

Sponsor

Manchanda Medical Clinic

Status

Unknown status

Last Update Posted

Feb 25, 2021Actual

Enrollment

40Estimated

Phase

Early Phase 1

Conditions

Prostatic Hyperplasia

Interventions

Placebo
papaverine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2021Estimated

Primary Completion Date

Sep 30, 2021Estimated

Completion Date

Dec 1, 2021Estimated

First Submitted Date

Dec 12, 2016

First Submission Date that Met QC Criteria

Feb 21, 2017

First Posted Date

Feb 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2021

Last Update Posted Date

Feb 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Drug free base as placebo	Other: Placebo
group two- papaverine arm	Experimental	papaverine in a suitable base	Drug: papaverine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	observation of skin changes if any	Placebo	drug free base

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Laboratory tests to measure regression of symptoms	patients follow-up on regular intervals	every 4 weeks up to 16 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with symptoms e.g. obstructive voiding, hyperplasia and high PSA

Exclusion Criteria:

patients on chemotherapy
abnormal lab values e.g. liver function, GFR and CAD

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
14761837	Background	Hafez B, Hafez ES. Andropause: endocrinology, erectile dysfunction, and prostate pathophysiology. Arch Androl. 2004 Mar-Apr;50(2):45-68.

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D044182	Benzylisoquinolines
D000470	Alkaloids
D006571	Heterocyclic Compounds
D053610	Opiate Alkaloids