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Mirabegron for Overactive Bladder (Dolphin Trial)
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.
- Overactive Bladder
- Mirabegron Pharmacokinetics
Dolphin Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDolphin Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 4 trial • 28 Patients • NCT02086188Dolphin Trial Design
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Who is running the clinical trial?
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- You have Overactive Bladder (OAB), which is diagnosed using the International Children's Continence Society (ICCS) criteria.
- Group 1: Placebo (5 to <12 Years)
- Group 2: Mirabegron (12 to <18 Years)
- Group 3: Mirabegron (5 to <12 Years)
- Group 4: Placebo (12 to <18 Years)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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