KRP-114V Phase I Clinical Trial in Pediatric Patients with Overactive Bladder

JRCT ID: jRCT2031220314

Registered date:02/09/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: overactive bladder.
• Date of first enrollment: 05/12/2022
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Cohort 1: 25 mg/day Cohort 2: 50 mg/day
Each cohort is administered orally once daily within 30 minutes after a meal.

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: < 15age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Mimaki Yoji