ONO-8539 non-erosive reflux disease study

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, two-period crossover study to investigate the effect of ONO-8539 on oesophageal pain hypersensitivity in patients with non-erosive reflux disease.

• IRAS ID

  110927

• Contact name

  Daniel Sifrim

• Sponsor organisation

  ONO Pharmaceutical Co., Ltd

• Eudract number

  2012-000462-37

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  The aim of the study is to assess the effects of the study compound on pain levels in the oesophagus. Also the aims are to assess the safety of the compound and how it effects the number of time the patient suffers the symptoms, the quality of the patients lives, how the compound moves through the body, how it is removed from the body, how much antacid the patients need to use. These will all be determined using collection of adverse events, questionnaires, and blood and urine tests. 30 subjects will enter the study and will first be treated with either placebo or study compound for 28 days. They will then go without treatment with study drug for at least 13 days and will then be treated for a further 28 days with the alternate treatment to what they were on the previous treatment period.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  12/EE/0359

• Date of REC Opinion

  5 Oct 2012

• REC opinion

  Further Information Favourable Opinion