OMS210 vs placebo in diarrhoea predominant irritable bowel syndrome

• Research type

  Research Study

• Full title

  A double-blind, randomised, parallel-group study to compare the safety and efficacy of two dose levels of OMS210 with placebo in the treatment of patients with diarrhoea predominant irritable bowel syndrome

• IRAS ID

  52633

• Contact name

  Glyn Chapman

• Sponsor organisation

  LOTUS PHARMACEUTICAL CO.,LTD

• Eudract number

  2010-019343-20

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Irritable bowel syndrome (IBS) is a name given to a group of bowel disorders in which abdominal discomfort or pain is associated with a change in bowel habit. Current therapies for IBS with diarrhoea (IBS-D) include anticholinergic drugs, anxiolytics, antidepressants and psychovegetative regulators. However, several associated side effects, including constipation and a risk of dependency, make these treatments less than ideal.OMS210 is being developed to work as a 5-HT3 receptor antagonist, which is hoped will improve the state of IBS-D in patients with less side effects. The studies run to date in healthy male volunteers have not given rise to any major safety concerns. This study will be run to gather further safety and efficacy data which will help in the development of OMS210. Patients will undergo a 2 week screening period to ensure they are suitable for the study, then a 4 week treatment period with a further 2 week follow up period. Patients will be seen at the GP clinics.

• REC name

  London - South East Research Ethics Committee

• REC reference

  10/H1102/32

• Date of REC Opinion

  30 Jun 2010

• REC opinion

  Further Information Favourable Opinion