On demand versus continuous use of omeprazole on reflux symptoms(3)

• Research type

  Research Study

• Full title

  The effect of on demand versus continuous use of proton pump inhibitors on reflux symptoms, quality of life and self-rated health in patients with gastro-oesophageal reflux disease

• IRAS ID

  156168

• Contact name

  Ellen Wright

• Contact email

  ellen.wright@kcl.ac.uk

• Sponsor organisation

  Centre for Family Medicine, Karolinska Institutet

• Eudract number

  2014-001314-25

• Duration of Study in the UK

  0 years, 3 months, 31 days

• Research summary

  Gastro-oesophageal reflux disease (GORD) includes a spectrum of disorders mainly caused by the backward flow of acid from the stomach into the oesophagus (gullet). Heartburn and acid regurgitation (a bitter burning taste at the back of the mouth) are the most typical symptoms of GORD. GORD is a chronic disease (prevalence 10-20 % in Europe) with a negative effect on quality of life (QoL). GORD is mainly treated in primary care with a proton pump inhibitor (PPI) eg 20 mg omeprazole once or twice daily or on demand. The data on which treatment regime is superior is conflicting and this lack of knowledge is likely to be related to the difficulties of performing large randomised controlled trials in primary care. In addition, patient reported outcomes such as symptom frequency and severity, QoL and self-rated health are important measures but are rarely used in primary care today.
  This study is designed as a randomized controlled trial to be performed at several primary health practices across Europe. The research question is “what gives most symptom relief and improvement in quality of life in patients with GORD, on demand or continuous use of proton pump inhibitors?” The full-scale study will include 10 countries with 10 primary care practices each, with10 patients per practice. The patients will be followed for 1 year. In this pilot study, the TRANSFoRm* tool will be tested in 5 countries with 8 primary care practices each, including 20 patients per practice. The patients will be followed for 8 weeks.
  * TRANSFoRm is a project to develop tools to facilitate the conduction of RCTs in primary care, including the collection of both care reported outcomes and patient reported outcomes . It also aims to develop a suite of software tools and underlying infrastructure to support primary and epidemiological research

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  14/WM/1196

• Date of REC Opinion

  28 Nov 2014

• REC opinion

  Further Information Favourable Opinion