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To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder

Primary Purpose

Overactive Bladder

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

JLP-2002 A mg

Placebo

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Those who are fully informed of this study and then completely understand its contents, voluntarily decide to participate in this study, and give written consent to follow instructions
Males or females aged 19 years or older at the time of written consent
Those who have already experienced symptoms of overactive bladder (OAB)* for 6 months or more at the time of screening
Those who are able to read, understand, and write in a voiding diary and a questionnaire
Those who are able to go to the toilet on foot without other's help

Exclusion Criteria:

Those who have a history of malignancies within 3 years before screening
Those who were previously or are currently diagnosed with urinary malignancies (e.g., bladder cancer)
Males who were previously or are currently diagnosed with prostate cancer or whose prostate-specific antigen (PSA) level is ≥ 4ng/mL within 1 year before screening or at screening
Those with a history of allergy to β-adrenergic receptor agonists, intolerant or clinically significant adverse events, or abnormal clinical laboratory values
Pregnant or lactating women
Those whose systolic blood pressure (SBP) is ≥160mmHg; diastolic blood pressure (DBP) is ≥100 mmHg; or pulse is ≥110 bpm at the time of screening and randomization
Those who received other investigational products or investigational devices within 30 days before screening
Those who are determined by the investigator to be not eligible for this study due to clinically significant abnormal findings of screening tests

Sites / Locations

Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

JLP-2002

Placebo

Arm Description

Drug: JLP-2002

Drug: Placebo

Outcomes

Primary Outcome Measures

Change From Baseline in Average Daily Micturitions at Week 12

Participants were required to keep a voiding diary, recording the occurrence of each micturition. The average daily number of micturitions was calculated as the total number of micturitions that occurred over 3 days during the Base Study, divided by the total number of days of voiding kept in the participant's diary. Baseline was defined as the average daily number of daily micturitions that occurred during the week of placebo run-in prior to Week 0 visit.

Secondary Outcome Measures

Full Information

NCT ID

NCT04917315

First Posted

June 2, 2021

Last Updated

January 26, 2022

Sponsor

Jeil Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04917315

Brief Title

To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Bridge Study to Evaluate the Efficacy and Safety of JLP-2002 in Patients With Overactive Bladder

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

May 21, 2020 (Actual)

Primary Completion Date

August 18, 2021 (Actual)

Study Completion Date

August 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jeil Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Overactive bladder (OAB) is a clinical condition characterized by urgency (i.e., urinary urinary urinary urgency that is difficult to delay and unbearable) with or without urge incontinence, usually associated with frequency and nocturia. The main drug class used is antimuscarinics, and the clinical utility of antimuscarinic drugs is limited due to its mild efficacy and poor tolerability due to side effects of mechanisms such as dry mouth and constipation. In addition to poor tolerability and mild efficacy, recent literature suggests that long-term use of anticholinergics is associated with cognitive impairment and dementia. Therefore, the purpose of this study was to evaluate the treatment effect of overactive bladder symptoms through the change in the average number of urination per day after administration of JLP-2002, a beta 3-adrenergic receptor (β3-AR) agonist with an effective alternative mechanism, for 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double blind

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

JLP-2002

Arm Type

Experimental

Arm Description

Drug: JLP-2002

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Drug: Placebo

Intervention Type

Drug

Intervention Name(s)

JLP-2002 A mg

Intervention Description

administration of JLP-2002 Participants received one vibegron A mg tablet, taken orally each morning, for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

administration of Placebo Participants received one placebo tablet, taken orally each morning, for 12 weeks.

Primary Outcome Measure Information:

Title

Change From Baseline in Average Daily Micturitions at Week 12

Description

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Those who are fully informed of this study and then completely understand its contents, voluntarily decide to participate in this study, and give written consent to follow instructions Males or females aged 19 years or older at the time of written consent Those who have already experienced symptoms of overactive bladder (OAB)* for 6 months or more at the time of screening Those who are able to read, understand, and write in a voiding diary and a questionnaire Those who are able to go to the toilet on foot without other's help Exclusion Criteria: Those who have a history of malignancies within 3 years before screening Those who were previously or are currently diagnosed with urinary malignancies (e.g., bladder cancer) Males who were previously or are currently diagnosed with prostate cancer or whose prostate-specific antigen (PSA) level is ≥ 4ng/mL within 1 year before screening or at screening Those with a history of allergy to β-adrenergic receptor agonists, intolerant or clinically significant adverse events, or abnormal clinical laboratory values Pregnant or lactating women Those whose systolic blood pressure (SBP) is ≥160mmHg; diastolic blood pressure (DBP) is ≥100 mmHg; or pulse is ≥110 bpm at the time of screening and randomization Those who received other investigational products or investigational devices within 30 days before screening Those who are determined by the investigator to be not eligible for this study due to clinically significant abnormal findings of screening tests

Facility Information:

Facility Name

Asan Medical Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder

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