IBS-D research study in paediatrics (ages 6-17 years)
Research type
Research Study
Full title
A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety and Efficacy of Eluxadoline in Paediatric Participants (Age 6 to 17 Years) with Irritable Bowel Syndrome with Diarrhoea (IBS-D)
IRAS ID
247797
Contact name
Minal Kara
Contact email
Sponsor organisation
Allergan LTD
Eudract number
2017-003770-14
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
79,214, IND Number
Duration of Study in the UK
0 years, 11 months, 20 days
Research summary
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorders (FGIDs) characterised by symptoms of abdominal discomfort or pain (belly pain) associated with altered bowel movements. Irritable Bowel Syndrome with Diarrhoea (IBS-D) is a condition where chronic or recurrent diarrhoea is the predominant stool pattern. \n\nThere are no therapies approved in the paediatric population for IBS-D in Europe or the USA. Thus, there is a need for new agents that are effective in providing sustained relief from the symptoms associated with IBS-D in paediatrics. \n\nThe purpose of this study is to evaluate the safety and efficacy of eluxadoline (study drug) in the treatment of IBS-D in paediatrics aged 12-17 years. The results from this study will help decide which dose of eluxadoline to evaluate in a future study.\n\nParticipants in the study will be randomly (by chance) assigned into one of four treatment groups:\n• Group 1: 25 mg of eluxadoline twice a day for 4 weeks\n• Group 2: 50 mg of eluxadoline twice a day for 4 weeks\n• Group 3: 100 mg of eluxadoline twice a day for 4 weeks\n• Group 4: placebo twice a day for 4 weeks\n\nThis is a double-blind, randomised, placebo controlled study meaning neither the participant, their parent/guardian, nor the study doctor will know the treatment group assignments. \n\nParticipants will attend six visits to the study clinic over a total of 9-11 weeks.\nAllergan is the sponsor of this global study with approximately 120 eligible participants aged 12-17 years.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
18/SW/0189
Date of REC Opinion
11 Oct 2018
REC opinion
Further Information Favourable Opinion