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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JLP-2002 | Experimental | Drug: JLP-2002 |
|
| Placebo | Placebo Comparator | Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JLP-2002 A mg | Drug | administration of JLP-2002 Participants received one vibegron A mg tablet, taken orally each morning, for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Double blind
| Placebo | Drug | administration of Placebo Participants received one placebo tablet, taken orally each morning, for 12 weeks. |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |