on-inferiority randomised, double-blind study comparing the efficacy of Gaviscon in oral suspension to 20mg omeprazole on pyrosis in patients with gastroesophageal reflux (GER) in which the current episode has not been treated with patient self-reporting questionnaires over a 14-day period.

Reckitt Benckiser Healthcare (France)0 个研究点目标入组 278 人开始时间: 2011年11月9日最近更新: 2021年1月5日

适应症

试验速览

•1. Male or female patient
•2. Aged 18 to 60 years
•3. Patient with between 2 and 6 episodes of GER per week with pyrosis, with or without regurgitation
•4. Patient not been treated for at least 2 months with an alginate/antacid combination or a proton pump inhibitor (PPI)
•5. Patient with signed informed consent form for participation in the study
•6. Patient able to understand and fill out the study self-questionnaires
•7. Patient affiliated with a national social security scheme
•8. Women using a form of contraception

•1. Patient with less than 2 episodes or over 6 episodes of GER with pyrosis per week
•2. Patient being treated with an alginate/antacid combination and/or a PPI in the two months preceding the inclusion
•3. Patient with mainly atypical, gastrointestinal or extra-intestinal symptoms, without symptoms of pyrosis
•4. Patient treated with clopidogrel
•5. Patient followed for a gastric or duodenal ulcer
•6. Patient with surgery of the upper digestive tract
•7. Patient with a neoplastic disorder of the upper digestive tract or ear, nose and throat
•8. Patient with known hypersensitivity to one of the components of Gaviscon and/or omeprazole
•9. Patient treated with atazanavir in combination with rotonavir
•10. Patient treated with ketoconazole and/or itraconazole
•11. Patient with known hypersensitivity to the benzimidazoles
•12. Breastfeeding women or those with known pregnancy
•13. Patient that refuses to participate in a clinical trial

发起方