Table 1.
Description of NERD and EO phase 3 studies
| NERD24 | EO25 | |
|---|---|---|
| Inclusion criteria | Men and women ≥18 years of age with a history of heartburn for ≥6 months, experiencing heartburn ≥4 of 7 days preceding randomisation, and normal oesophageal mucosa at screening endoscopy | Men and women ≥18 years of age with endoscopically confirmed EO. Patients with more severe EO (LA grade C and D) were to compose 30% of the study group |
| Exclusion criteria* | Pregnancy or lactation; active gastric/duodenal ulcers ≤4 weeks of first dose of study drug; coexisting oesophageal disease, including BO; use of PPI, H2RA or antacid; known hypersensitivity to PPI; long-term NSAID use | H. pylori-positive; pregnancy or lactation; use of any PPI or H2RA during screening; chronic NSAID use; coexisting diseases of the oesophagus, including BO; active gastric/duodenal ulcers or acute upper GI haemorrhage ≤4 weeks of first dose of study drug |
| Study drug | Dexlansoprazole MR 30 mg, n = 315 | Dexlansoprazole MR 60 mg, n = 1374 |
| Dexlansoprazole MR 60 mg, n = 315 | Dexlansoprazole MR 90 mg, n = 1355 | |
| Placebo, n = 317 | Lansoprazole 30 mg, n = 1363 | |
| Study design | Randomised, double-blind, multicentre, placebo-controlled. After 1:1:1 randomisation on Day -1, patients self-administered study drug QD for 4 weeks. Efficacy assessments were conducted at Weeks 2 and 4. Open-label antacid was provided as rescue medication | Randomised, double-blind, multicentre, active-controlled. After 1:1:1 randomisation on Day -1, patients self-administered study drug QD for 8 weeks. Efficacy assessments were conducted at Weeks 4 and 8. Open-label antacid was provided as rescue medication |
| Primary efficacy endpoint | Percentage of 24-h heartburn-free days during treatment as assessed by daily electronic diary | Percentage of patients who had complete EO healing over 8 weeks as assessed by endoscopy |
| Secondary and additional efficacy endpoints* | Mean percentage of days without nighttime heartburn over 4 weeks as assessed by daily electronic diary; mean severity of heartburn | Percentage of patients who had complete EO healing over 4 weeks; percentage of subjects with Grade C and E who had complete healing over 4 weeks; percentage of 24-h heartburn-free days; mean severity of heartburn |
BO, Barrett's oesophagus; EO, erosive oesophagitis; H2RA, histamine-2 receptor antagonist; LA, Los Angeles; MR, modified release; NERD, non-erosive oesophageal reflux disease; NSAID, nonsteroidal anti-inflammatory drugs; PPI, proton pump inhibitor; QD, once daily.
*
Not exhaustive; refer to original publications for complete lists.