Dolphin Study
Research type
Research Study
Full title
A Phase 3, Double blind, Randomized, Multicenter, Parallel Group, Placebo controlled Sequential Dose Titration Study to Evaluate Efficacy, Safety and Pharmacokinetics of Mirabegron in Pediatric Subjects from 5 to < 18 Years of Age with Overactive Bladder
IRAS ID
1003219
Contact name
Vaiva Smilgiute
Contact email
Sponsor organisation
Astellas Pharma Global Development Inc.
Eudract number
2016-001767-37
Research summary
Research Summary
This research study is organised and supported by Astellas Pharma Global Development. The study purpose is to evaluate if mirabegron is an effective and safe treatment for children and adolescents (5 < 18 years) with overactive bladder (OAB). OAB causes a sudden, uncontrolled need to urinate. Some people will leak urine when they feel this urge. OAB can also cause a need to pass urine very frequently, including during the night.
Mirabegron tablets are currently approved as Betmiga for the treatment OAB in adults in the UK. Current treatment for OAB in children includes antimuscarinics and development of alternative therapies is desirable due to insufficient efficacy and/or the side effects of available therapies. By relaxing muscles in the bladder mirabegron reduces frequency and urge to urinate, thereby improving the ability to remain dry. Mirabegron also protects the kidneys by allowing more urine into the bladder before reaching a pressure in the bladder that is dangerous for the kidneys.
Mirabegron will be tested over a 12-week period of daily treatment; it will be compared to a placebo which looks like mirabegron but has no active ingredients. Participants will have a 50:50 chance (like flipping a coin) of receiving mirabegron or placebo. This is a double−blind study meaning neither the participant nor the study doctor will know which medication is being administered.
Mirabegron comes in a tablet and a liquid form. The liquid form of mirabegron is not yet on the market, as it is being developed for children. The liquid formulation has been used in previous clinical studies in adults and children during its development program. Whether a paediatric participant receives mirabegron tablets or liquid will be based on body weight and ability to swallow tablets.
Approximately 430 participants at approximately 65 study centres worldwide will participate in this study.
Summary of Results
This study is about children and teenagers who need to pass urine often and have trouble holding in their urine. This is known as overactive bladder, or OAB. In this study, children and teenagers with OAB took mirabegron, a treatment that helps relax the muscles around the bladder. Too few children and teenagers took part, so the researchers couldn't be sure if mirabegron changed how often the children and teenagers needed to pass urine.
REC name
Wales REC 3
REC reference
21/WA/0224
Date of REC Opinion
21 Sep 2021
REC opinion
Further Information Favourable Opinion