Gastroscopy study of netazepide and H. pylori infection; version 1

• Research type

  Research Study

• Full title

  Can netazepide eradicate the inflammatory response of the gastric mucosa to H. pylori infection? (12-502)

• IRAS ID

  117417

• Contact name

  Malcolm Boyce

• Eudract number

  2012-002183-27

• ISRCTN Number

  n/a

• Research summary

  Helicobacter pylori (H. pylori) are bacteria that are resistant to acid, so they are able to grow in the stomach. In most people, H. pylori infection causes no symptoms. But, it can inflame the stomach lining and make it produce gastrin ?? a hormone that triggers stomach acid production, growth of the stomach lining and growth of more H. pylori. Those effects can lead to a stomach ulcer and indigestion. Netazepide (the study medicine) is an experimental treatment for disorders associated with an increased level of gastrin. It works by blocking the effects of gastrin. So, the aim of the study is to find out if netazepide can improve the inflammation caused by H. pylori. We're doing this study in men or women (aged 30-75) who have the H. pylori infection and who show signs of stomach lining inflammation at gastroscopy. Participants will take netazepide 50 mg (2 capsules) or a matching dummy medicine once daily for 12 weeks. monitor signs of stomach health and function by: measuring markers in the blood; doing gastroscopies to look at the stomach; and taking small samples of the stomach lining for analysis. Participants will take up to 17 weeks to finish the study. They'll make 7 visits, 5 of which will be outpatient visits. At Visit 2, they'll stay on the ward for 2 nights and at Visit 6 they'll stay for 1 night. A pharmaceutical company, TRIO Medicines Ltd is funding the study. The study will take place at 1 centre in London. recruit participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/1813

• Date of REC Opinion

  24 Dec 2012

• REC opinion

  Further Information Favourable Opinion