overactive bladder.
Conditions
Interventions
Cohort 1: 25 mg/day Cohort 2: 50 mg/day
Each cohort is administered orally once daily within 30 minutes after a meal.
Sponsors
Mimaki Yoji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged between 5 and 15 years at the time of consent, regardless of gender. - Patients who have been symptomatic for at least 3 months prior to Day 21 (Visit 1) and have been diagnosed with overactive bladder as defined by the ICCS. - Patients weighing more than15 kg
Exclusion criteria
Exclusion criteria: - Patients with serious or congenital cardiac, hepatic, renal, hematological, or other complications - Patients with a history of allergy, intolerance, or serious adverse reactions to beta-adrenergic receptor agonists. - Patients with clinically relevant abnormalities on 12-lead electrocardiography - Patients with monosymptomatic nocturia, enuresis, urinary calculi, urinary tract infection, interstitial cystitis, neurogenic bladder, or Patients with clinically problematic lower urinary tract obstruction. - Patients with a residual urine volume of more than 20 mL immediately after voiding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints - Adverse events, Adverse Drug Reactions - Symptoms and Other Findings - Body weight - Vital signs (blood pressure, pulse rate) - 12-lead electrocardiography, - Laboratory tests (hematology, biochemistry, urinalysis) - Residual urine volume Pharmacokinetic endpoints - Plasma concentration of KRP-114V - Pharmacokinetic parameters of KRP-114V | — |
Contacts
Public ContactYoji Mimaki
KYORIN Pharmaceutical Co.,Ltd.
Outcome results
None listed