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出境医 / 临床实验 / To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder

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

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: JLP-2002 A mg Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double blind
Primary Purpose: Treatment
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
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : November 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: JLP-2002
Drug: JLP-2002
 Drug: JLP-2002 A mg
administration of JLP-2002 Participants received one vibegron A mg tablet, taken orally each morning, for 12 weeks.
Placebo Comparator: Placebo
Drug: Placebo
 Drug: Placebo
administration of Placebo Participants received one placebo tablet, taken orally each morning, for 12 weeks.
Outcome Measures
Primary Outcome Measures :
  1. Change From Baseline in Average Daily Micturitions at Week 12 [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Males or females aged 19 years or older at the time of written consent
  3. Those who have already experienced symptoms of overactive bladder (OAB)* for 6 months or more at the time of screening
  4. Those who are able to read, understand, and write in a voiding diary and a questionnaire
  5. Those who are able to go to the toilet on foot without other's help

Exclusion Criteria:

  1. Those who have a history of malignancies within 3 years before screening
  2. Those who were previously or are currently diagnosed with urinary malignancies (e.g., bladder cancer)
  3. 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
  4. Those with a history of allergy to β-adrenergic receptor agonists, intolerant or clinically significant adverse events, or abnormal clinical laboratory values
  5. Pregnant or lactating women
  6. 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
  7. Those who received other investigational products or investigational devices within 30 days before screening
  8. Those who are determined by the investigator to be not eligible for this study due to clinically significant abnormal findings of screening tests
Contacts and Locations

Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Jeil Pharmaceutical Co., Ltd.
Tracking Information
First Submitted Date  ICMJE June 2, 2021
First Posted Date  ICMJE June 8, 2021
Last Update Posted Date June 8, 2021
Actual Study Start Date  ICMJE May 21, 2020
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2021) 		Change From Baseline in Average Daily Micturitions at Week 12 [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Evaluate the Efficacy and Safety of JLP-2002 on Symptoms of Overactive Bladder
Official Title  ICMJE A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Bridge Study to Evaluate the Efficacy and Safety of JLP-2002 in Patients With Overactive Bladder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double blind
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • Drug: JLP-2002 A mg
    administration of JLP-2002 Participants received one vibegron A mg tablet, taken orally each morning, for 12 weeks.
  • Drug: Placebo
    administration of Placebo Participants received one placebo tablet, taken orally each morning, for 12 weeks.
Study Arms  ICMJE
  • Experimental: JLP-2002
    Drug: JLP-2002
    Intervention: Drug: JLP-2002 A mg
  • Placebo Comparator: Placebo
    Drug: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 2, 2021) 		210
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2021
Estimated Primary Completion Date August 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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
  2. Males or females aged 19 years or older at the time of written consent
  3. Those who have already experienced symptoms of overactive bladder (OAB)* for 6 months or more at the time of screening
  4. Those who are able to read, understand, and write in a voiding diary and a questionnaire
  5. Those who are able to go to the toilet on foot without other's help

Exclusion Criteria:

  1. Those who have a history of malignancies within 3 years before screening
  2. Those who were previously or are currently diagnosed with urinary malignancies (e.g., bladder cancer)
  3. 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
  4. Those with a history of allergy to β-adrenergic receptor agonists, intolerant or clinically significant adverse events, or abnormal clinical laboratory values
  5. Pregnant or lactating women
  6. 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
  7. Those who received other investigational products or investigational devices within 30 days before screening
  8. Those who are determined by the investigator to be not eligible for this study due to clinically significant abnormal findings of screening tests
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04917315
Other Study ID Numbers  ICMJE JLP-2002-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeil Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Jeil Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jeil Pharmaceutical Co., Ltd.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP