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Beta-3 Adrenergic Agonist

Mirabegron for Overactive Bladder (Dolphin Trial)

Phase 3
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has OAB defined according to the International Children's Continence Society (ICCS) criteria.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 4, 12, 14
Awards & highlights

Dolphin Trial Summary

This trial will evaluate the effectiveness of mirabegron in children with OAB, as well as its safety and how it is metabolized in the body.

Eligible Conditions
  • Overactive Bladder
  • Mirabegron Pharmacokinetics

Dolphin Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have Overactive Bladder (OAB), which is diagnosed using the International Children's Continence Society (ICCS) criteria.

Dolphin Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 4, 12, 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 4, 12, 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline to Week 12/EoT in Mean Number of Micturitions Per 24 Hours for Age Group 5 to <12 Years
Secondary outcome measures
Change From Baseline in Post Void Residual (PVR) Volume
Change From Baseline to Week 12/EoT in Maximum Volume Voided (MVV) for Age Group 5 to <12 Years
Change From Baseline to Week 12/EoT in Mean Number of Daytime Incontinence Episodes Per 24 Hours for Age Group 5 to <12 Years
+13 more

Side effects data

From 2019 Phase 4 trial • 28 Patients • NCT02086188
7%
gastritis
7%
urinary tract infection
7%
asthma
7%
fatigue
7%
diarrhea
7%
headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mirabegron
Placebo

Dolphin Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Mirabegron (5 to <12 Years)Experimental Treatment1 Intervention
Participants aged 5 to < 12 years received initial dose of 25 milligram (mg) of mirabegron orally once daily based on weight (pediatric equivalent dose of 25 mg [PED25]) on day 1. Participants with a body weight ≥ 35 kilogram (kg) received tablet and participants with a body weight< 35 kg or those who could not be dosed with the tablet received an oral suspension. At week 4, participants were up-titrated to the pediatric equivalent dose of 50 mg [PED50] based on the given dose titration criteria up to week 12. Urotherapy continued throughout the study treatment period until week 12.
Group II: Mirabegron (12 to <18 Years)Experimental Treatment1 Intervention
Participants aged 12 to < 18 years received initial dose of 25 mg of mirabegron orally once daily based on weight PED25 on day 1. Participants with a body weight ≥ 35 kg received tablet and participants with a body weight< 35 kg or those who could not be dosed with the tablet received an oral suspension. At week 4, participants were up-titrated to the PED50 based on the given dose titration criteria up to week 12. Urotherapy continued throughout the study treatment period until week 12.
Group III: Placebo (5 to <12 Years)Placebo Group1 Intervention
Participants aged 5 to < 12 years received placebo matched to mirabegron orally once daily based on weight PED25 on day 1. Participants with a body weight ≥ 35 kg received tablet and participants with a body weight< 35 kg or those who could not be dosed with the tablet received an oral suspension. At week 4, participants were up-titrated to the PED50 based on the given dose titration criteria up to week 12. Urotherapy continued throughout the study treatment period until week 12.
Group IV: Placebo (12 to <18 Years)Placebo Group1 Intervention
Participants aged 12 to < 18 years received placebo matched to mirabegron orally once daily based on weight PED25 on day 1. Participants with a body weight ≥ 35 kg received tablet and participants with a body weight< 35 kg or those who could not be dosed with the tablet received an oral suspension. At week 4, participants were up-titrated to the PED50 based on the given dose titration criteria up to week 12. Urotherapy continued throughout the study treatment period until week 12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirabegron
2008
Completed Phase 4
~18640

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
121,001 Total Patients Enrolled
Medical MonitorStudy DirectorAstellas Pharma Global Development, Inc.
1,649 Previous Clinical Trials
979,832 Total Patients Enrolled

Media Library

Mirabegron (Beta-3 Adrenergic Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04641975 — Phase 3
Overactive Bladder Research Study Groups: Placebo (5 to <12 Years), Mirabegron (12 to <18 Years), Mirabegron (5 to <12 Years), Placebo (12 to <18 Years)
Overactive Bladder Clinical Trial 2023: Mirabegron Highlights & Side Effects. Trial Name: NCT04641975 — Phase 3
Mirabegron (Beta-3 Adrenergic Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04641975 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most severe side effects that have been reported with Mirabegron?

"The available data from Phase 3 trials gives our team the Mirabegron a safety rating of 3."

Answered by AI

Does this research include older individuals as test subjects?

"To be eligible for this particular study, applicants must be between the ages of 5 and 17. In contrast, there are 71 clinical trials for patients over the age of 65 and only 9 for patients younger than 18."

Answered by AI

Are patients being accepted into the program at this time?

"This trial is still recruiting patients, with the initial posting on clinicaltrials.gov being on 2021-04-12 and the most recent edit being on 2022-10-02."

Answered by AI

What other studies have included Mirabegron in their research?

"12 different clinical trials for Mirabegron are currently underway, with 2 in Phase 3. The global distribution of these trials is diverse, with a notable presence in Marseille and Seoul."

Answered by AI

Which type of patient would best be suited for this research?

"In order to qualify for this study, patients must exhibit symptoms of overactive bladder syndrome (OAB) and be between 5 and 17 years of age. A total of 432 children will be accepted into the trial."

Answered by AI

How many people will be able to participate in this clinical trial?

"Yes, this is an active recruitment according to the information provided on clinicaltrials.gov. The trial was first posted on April 12th, 2021 and was most recently updated on October 2nd, 2022. There is one site for this trial and 432 patients are needed."

Answered by AI
~6 spots leftby Mar 2025