The data do not support the indication “prevention of symptoms” nor “prophylaxis of gastroduodenal erosions”. • Symptomatic gastroesophageal reflux disease (4.1 and 4.2) Two pivotal randomised, double-blind, parallel-group trials and 5 supportive studies to evaluate the efficacy of lansoprazole for treatment of symptomatic gastroesophageal reflux disease were submitted.
Lansoprasooli efektiivsuse hindamiseks sümptomaatilise gastroösofageaalse refluksi raviks esitati kahe pöördelise topeltpimeda paralleelrühmaga uuringu tulemused ja viie toetava uuringu tulemused.