A Phase 2, Randomized, Placebo-controlled, Double-blind S... | NCT05674045

Studies
A Phase 2, Randomized, Placebo-controlled, Double-blind Study of EG017 in Female Patients With Stress Urinary Incontinence

NCT05674045

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Jan 6, 2023Actual

Enrollment

51Actual

Phase

Phase 2

Conditions

Stress Urinary Incontinence

Interventions

EG017 3mg
EG017 6mg

Countries

China

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 6, 2022Actual

Primary Completion Date

Jan 6, 2022Actual

Completion Date

Sep 26, 2022Actual

First Submitted Date

Dec 30, 2022

First Submission Date that Met QC Criteria

Dec 30, 2022

First Posted Date

Jan 6, 2023Actual

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

Dec 30, 2022

Last Update Posted Date

Jan 6, 2023Actual

Name	Class
Peking University People's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine whether EG017 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.

Detailed Description

The main purpose of this study is to assess the efficacy of EG017 in female patients with stress urinary incontinence (SUI) compared with placebo as measured by the percent change in the urinary incontinence volume measured in a 1-hour pad test from baseline at week 12.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
EG017 3mg	Experimental	Drug: EG017 3mg
EG017 6mg	Experimental	Drug: EG017 6mg
EG017 9mg	Experimental	Drug: EG017 3mg Drug: EG017 6mg
Placebo Comparator: matching placebo	Placebo Comparator	Drug: EG017 3mg Drug: EG017 6mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EG017 3mg	Drug	EG017 3mg/day Oral administration for 12 weeks, once daily	EG017 3mg EG017 9mg Placebo Comparator: matching placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the percent change in the urinary incontinence volume measured in a 1-hour pad test		Baseline, week 12

Secondary Outcomes

Measure	Description	Time Frame
The percent change in urinary incontinence volume measured in a 24-hour pad test		Baseline, week 12
The percent change in urinary incontinence volume measured in 1-hour and 24-hour pad test		Baseline, week 8 week20

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

SUI symptoms of at least 6 months duration Urinary incontinence in the 1-hour pad test weight≥5g and<30 g Moderate to severe urinary incontinence evaluated by ICIQ-SF

Exclusion Criteria:

Patient has been diagnosed with mixed urinary incontinence (MUI) that is predominantly UUI Patient is considered to have SUI that would not be expected to improve unless treated with surgical therapy Patient had a history of surgical treatment for urinary incontinence (Trans-obturator tape surgery, Tension-free vaginal tape surgery, etc.) Patient has stage II or more of Pelvic Organ Prolapse (POP), or had a history of POP repair surgery before prior to study entry Patient has a serious illness or medical condition

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
People's Hospital of Peking University		Beijing	Beijing Municipality	100000	China

Condition Browse Module

MeSH Terms

ID	Term
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided