Clinical trial: the effects of the proton pump inhibitor dexlansoprazole MR on daytime and nighttime heartburn in patients with non‐erosive reflux disease

Summary Background The proportion of patients who respond to proton pump inhibitor (PPI) therapy is about 20% lower in those with non‐erosive reflux disease (NERD) than in those with erosive oesophagitis. Aim To assess efficacy and safety of dexlansoprazole MR, a PPI using Dual Delayed Release technology, in NERD patients. Methods In this 4‐week, double‐blind, placebo‐controlled study, 947 NERD patients randomly received dexlansoprazole MR 30 mg, 60 mg or placebo once daily (QD). The percentages of 24‐h heartburn‐free days (primary) and nights without heartburn (secondary) were assessed from patients’ daily diaries. Investigators also assessed symptoms. Patients completed validated quality of life and symptom severity questionnaires. Results Dexlansoprazole MR provided significantly greater median percentages of 24‐h heartburn‐free days (54.9% and 50.0% for the 30‐ and 60‐mg doses vs. 17.5% for placebo, P