BACKGROUND:Nocturnal heartburn is common in patients with gastro-oesophageal reflux disease (GERD). AIM: To compare the effects of single doses of rabeprazole 20 mg and pantoprazole 40 mg on 24-h intragastric acidity and oesophageal acid exposure (OAE). METHODS: A total of 52 subjects with GERD and a >or=6-month history of heartburn were randomized into a blinded, 2 x 2 crossover trial. Subjects' intragastric pH was monitored in two 48-h study periods with 6- to 13-day washout between periods. Patients received placebo on day 1, a single dose of rabeprazole 20 mg or pantoprazole 40 mg on day 2, and standardized meals throughout. RESULTS: The mean percentage time with intragastric pH >4 was significantly greater with rabeprazole vs. pantoprazole for the 24-h postdose interval (44.0% vs. 32.8%; P < 0.001). Significant differences were observed in the daytime (51.0% vs. 42.2%; P < 0.001) and nighttime (32.0% vs. 16.9%; P < 0.001). Rabeprazole was also significantly superior in other intragastric pH parameters. There was no statistical difference for OAE between treatments. CONCLUSIONS: In GERD patients with nocturnal heartburn, rabeprazole 20 mg was significantly more effective than pantoprazole 40 mg in percentage time with intragastric pH >4 during the nighttime, daytime, and 24-h periods. Differences between treatments in OAE were not demonstrated. This trial is registered with http://clinicaltrials.gov, number NCT00237367.
RCT Entities:
BACKGROUND:Nocturnal heartburn is common in patients with gastro-oesophageal reflux disease (GERD). AIM: To compare the effects of single doses of rabeprazole 20 mg and pantoprazole 40 mg on 24-h intragastric acidity and oesophageal acid exposure (OAE). METHODS: A total of 52 subjects with GERD and a >or=6-month history of heartburn were randomized into a blinded, 2 x 2 crossover trial. Subjects' intragastric pH was monitored in two 48-h study periods with 6- to 13-day washout between periods. Patients received placebo on day 1, a single dose of rabeprazole 20 mg or pantoprazole 40 mg on day 2, and standardized meals throughout. RESULTS: The mean percentage time with intragastric pH >4 was significantly greater with rabeprazole vs. pantoprazole for the 24-h postdose interval (44.0% vs. 32.8%; P < 0.001). Significant differences were observed in the daytime (51.0% vs. 42.2%; P < 0.001) and nighttime (32.0% vs. 16.9%; P < 0.001). Rabeprazole was also significantly superior in other intragastric pH parameters. There was no statistical difference for OAE between treatments. CONCLUSIONS: In GERDpatients with nocturnal heartburn, rabeprazole 20 mg was significantly more effective than pantoprazole 40 mg in percentage time with intragastric pH >4 during the nighttime, daytime, and 24-h periods. Differences between treatments in OAE were not demonstrated. This trial is registered with http://clinicaltrials.gov, number NCT00237367.