BACKGROUND/AIMS: This randomized, double-blind, phase III, multicenter trial was carried out to compare the efficacy and safety of revaprazan, a novel acid pump antagonist, with that of omeprazole in patients with more than one of gastric ulcers. METHODS: Two hundred and ninety two subjects were randomized to 4~8 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg. The primary efficacy parameter was the cumulative healing rate determined by endoscopy after 4 and 8 weeks of treatment, and the secondary efficacy parameter was an improvement rate of pain. RESULTS: The intention-to-treat analysis revealed revaprazan and omeprazole to have similar cumulative healing rates (93.0% and 89.6%, respectively; p=0.3038). The per-protocol analysis revealed revaprazan and omeprazole to also have similar cumulative healing rates (99.1% and 100%, respectively; p= 0.3229). In both analyses, there were no significant differences in an improvement rate of pain between the two groups. Both drugs were well tolerated. CONCLUSIONS: Revaprazan has similar efficacy to omeprazole in the treatment of patients with gastric ulcer with a once a day application of revaprazan 200 mg or omeprazole 20 mg over a 4 to 8-week period. In terms of safety, revaprazan was well tolerated.
Endoscopy ; Humans ; Omeprazole ; Stomach Ulcer*

No abstract available.
Baclofen* ; Drug Therapy, Combination* ; Hiccup* ; Omeprazole*

BACKGROUND/AIMS: To assess the comparative efficacy and safety of revaprazan, a novel acid pump antagonist, versus omeprazole in patients with duodenal ulcer, we performed a randomized, double-blind, phase III, multicenter trial. METHODS: Two hundred and twenty eight patients were randomized to 4 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg once daily. Primary efficacy parameter was complete ulcer healing by endoscopy, and secondary parameter was the improvement in the severity of daytime and nighttime pain. RESULTS: Healing rates at 4 weeks (intention-to-treat analysis) were 91.7% with revaprazan 200 mg and 91.3% with omeprazole 20 mg; there were no significant differences between two groups (p=0.9228). In per-protocol analysis, healing rates of revaprazan 200 mg and omeprazole 20 mg were 94.4% and 92.3%, respectively. There was no significant difference in healing rate between two groups (p=0.5666). There was no significant difference between two groups in improvement rates of daytime and nighttime pain. Both drugs were well tolerated. CONCLUSIONS: Revaprazan 200 mg was equivalent to omeprazole 20 mg for both ulcer healing and symptom relief, and was well tolerated in patients with duodenal ulcer.
Duodenal Ulcer* ; Endoscopy ; Humans ; Omeprazole ; Ulcer

BACKGROUND/AIMS: To compare efficacy and tolerability of rabeprazole (RAB) 10 mg versus omeprazole (OME) 20 mg in patients with duodenal ulcer. METHODS: This randomized, comparative, multicenter study was conducted at 10 centers in Korea, from February to September in 1999. Patients with active duodenal ulcer as proven by endoscopy were randomized to RAB (n=123) or OME (n=123) groups. One hundred-twenty-three patients received RAB 10 mg once daily, and 123 patients received OME 20 mg once daily for 2 or 4 weeks. Primary efficacy parameter was complete healing by endoscopy and secondary parameter was the improvement in the severity of clinical symptoms after the therapy. RESULTS: After 2 weeks, complete healing was achieved in 81.7% (85/104) of patients given RAB 10mg and in 81.1% (77/95) of patients given OME 20 mg (p=0.902). After 4 weeks, complete healing was documented in 97.1% (101/104) of patients given RAB 10 mg and in 93.7% (89/95) of patients given OME 20 mg (p=0.315). The percentages of patients resolved daytime pain and night-time pain at Day 4 were 87.5% and 90.1% in RAB group and 79.0% and 80.5% in OME group (p=0.138 and p=0.087 for day-time k night-time pain, respectively). No clinically meaningful changes or other between-group differences were observed in laboratory parameters and adverse events which were evaluated to be related with medication. CONCLUSIONS: In this study, rabeprazole 10 mg produced healing rates and symptom relief equivalent to omeprazole 20 mg at weeks 2 and 4 in patients with active duodenal ulcer and provided a tendency of faster symptom relief than omeprazole 20 mg, although it didn't reach statistical significance. Both the treatments were well tolerated.
Duodenal Ulcer* ; Endoscopy ; Humans ; Korea ; Omeprazole* ; Rabeprazole*

BACKGROUND/AIMS: This study was performed to test whether there is some difference between combined endoscopic therapy with PPI infusion and intravenous PPI therapy alone. METHODS: A total of seventy-three high-risk patients with ulcer bleeding and non-bleeding visible vessels or fresh adherent clots resistant to irrigation were randomized to medical therapy [intravenous omeprazole therapy alone: 40 mg IV per day for 3~5 days] or to endoscopic combination therapy [endoscopic epinephrine (1 : 10,000 in normal saline) or ethanol injection followed by intravenous omeprazole infusion]. RESULTS: Patients were similar at study entry. Ulcer bleeding recurred in two patients who received combined endoscopic therapy (2/35, 5.7%) while ulcer bleeding recurred in ten patients who received intravenous omeprazole alone (10/38, 26.3%) (p < 0.05). Two patients (2/35, 5.7%) in the combined therapy group and five patients (5/38, 13.2%) in the omeprazole infusion alone group had surgery for intractable bleeding (p=0.281). One patient in each group died within the hospital stays (p=0.953). CONCLUSIONS: The combination of endoscopic injection therapy with omeprazole infusion is superior to omeprazole infusion alone for preventing recurrent bleeding from ulcers with nonbleeding visible vessels or adherent clots.
Epinephrine ; Ethanol ; Hemorrhage* ; Humans ; Length of Stay ; Omeprazole* ; Peptic Ulcer* ; Ulcer

BACKGROUND/AIMS: The aim of this study was to ascertain the effects of two week treatment of omeprazole (O) and clarithromycin (C) with and without metronidazole (M), and one week treatment of omeprazole, clarithromycin and metronidazole, for the eradieation of Helicobacter pylori (H. pylori) in patients with peptic ulcer disease in double-blind, randomly controlled groups. METHODS: The H. pylori infection determined in patients whose results were positive in a rapid urease test or in those who exhibited histology in antrum and body, The OC14 group received O 40 mg qd and C 500 mg t.i.d. for 2 weeks; the OCM14 group received O, C, and M 250 mg t.i.d for 2 weeks, and the OCM7 group received O, C, M for 1 week, respectively. H. pylori eradication was assessed 4 weeks after the end of treatment. The H. pylori eradication was determined as all negative for the rapid urease test and histology on both the antrum and body.
Clarithromycin* ; Helicobacter pylori* ; Helicobacter* ; Humans ; Metronidazole* ; Omeprazole* ; Peptic Ulcer* ; Urease

In this study, we investigated the protective action of glucuronopyranoside flavonoids (QGC, AGC, LGC) on gastritis in rats. QGC, AGC and omeprazole decreased the gastric volume significantly, and each ID50 was 0.75, 0.54 and 8.5 mg/kg, respectively, thus the order of potency was AGC, QGC and omeprazole. They also decreased acid output, and each ID50 was 7.81, 0.58 and 6.71 mg/kg, respectively, thus the order of potency was AGC, omeprazole and QGC. They inhibited gastritis induced by indomethacin, and it recovered significantly by increasing the GSH levels in gastritis. The gastric MPO activity in the gastritis group increased more than in the normal group. QGC, LGC, or AGC administration reduced moderately the MPO activity in a dose-dependent manner. This study demonstrated that AGC, QGC, or LGC showed potent efficacy on the gastritis, by preventing oxidative stress. These results suggest that QGC, AGC, or LGC have gastroprotective effect in rats.
Animals ; Flavonoids* ; Gastritis ; Indomethacin ; Lipid Peroxidation ; Omeprazole ; Oxidative Stress ; Rats*

Antiulcer effects of YH1238 and YH1885 were determined in the isolated gastric cells from human and rabbit stomach. Intracellular accumulation of (14C)-aminopyrine and (14C)-glucose oxidation were used as indicators of acid secretory ability of the gastric cells. Unstimulated and stimulated gastric cells with dibutyryl cAMP (10(-3) M) were used and the inhibitory effects of YH1238 and YH1885 on acid secretion were compared with known proton pump inhibitors such as omeprazole and SK&F 96067. Dibutyryl cAMP stimulated the (14C)-aminopyrine accumulation and (14C)-glucose oxidation, which were inhibited by YH1238, YH1885, SK&F 96067 and omeprazole. Inhibitory effects of YH1238, YH1885 and omeprazole on (14C)-aminopyrine accumulation in stimulated gastric cells were more potent than that of SK&F 96067 at the concentration of 10(-5) M. It is suggested that the reversible proton pump inhibitors YH1238 and YH1885 would be effective antiulcer agents.
Humans ; Omeprazole ; Proton Pump Inhibitors* ; Proton Pumps* ; Protons* ; Stomach

BAKGROUND/AIMS: Eradication of Helicobacter pylori infection is highly efficacious in preventing the recurrence of peptic ulcer. Rebamipide (Mucosta(R)) is known to have the ability to inhibit neutrophil activity, to reduce the production of inflammatory cytokines, to scavenge oxygen radical, and to stimulate prostaglandin production. This study was designed to evaluate the effect of rebamipide on the eradication of H. pylori, and decrease of the infilatration of inflammatory cells. METHODS: Eighty two patients with gastric or duodenal ulcers with H. pylori infection were allocated to two treatment groups. The patients were treated either with omeprazole 40 mg, clarithromycin 1.0 g, amoxicillin 2.0 g, rebamipide 300 mg (OCAR group) or omeprazole 40 mg, clarithromycin 1.0 g, amoxicillin 2.0 g (OCA group) for two weeks. RESULTS: H. pylori was eradicated 56 out of 62 patients (90%) in OCAR group and 16 out of 20 patients (80%) in OCA group. The infiltration of inflammatory cells decreased in both treatment groups. No significant side effects had been noticed. CONCLUSIONS: The results of the present study suggest that rebamipide may be useful to decrease gastric mucosal inflammation in peptic ulcer disease. However, further detailed study will be reqiured to determine the potentially beneficial effect whether rebamipide can prevent the recurrence of peptic ulcer diseases with H. pylori infection.
Amoxicillin ; Clarithromycin ; Cytokines ; Duodenal Ulcer ; Helicobacter pylori* ; Helicobacter* ; Humans ; Inflammation ; Neutrophils ; Omeprazole ; Oxygen ; Peptic Ulcer ; Recurrence

BACKGROUND/AIMS: There have been few studies on the efficacy of proton pump inhibitors and the doses required to treat dyspeptic symptoms observed in clinical practice. The aim of this study was to compare the efficacy of different doses of omeprazole and different administration methods in Helicobacter pylori-negative, dyspeptic patients. METHODS: Patients with chronic upper abdominal symptoms within the previous 3 months were randomly divided into three groups: a daily, omeprazole 20 mg treatment group (OPZ20, n=61); a daily, omeprazole 10 mg treatment group (OPZ10, n=72); and an on-demand omeprazole 20 mg treatment group (on-demand, n=62). After 4 weeks of administration of the drug, symptom improvement rates were evaluated based on the Overall Global Severity score. RESULTS: The rates of symptom improvement after 4 weeks of treatment were 65.6% (40/61) in the OPZ20 group, 47.2% (34/72) in the OPZ10 group, and 50.0% (31/62) in the on-demand group. The OPZ20 group exhibited a significantly higher improvement rate (p=0.034) than the OPZ10 group. The OPZ20 group had significant improvements in regurgitation, postprandial fullness, vomiting, and bloating compared with the OPZ10 group. CONCLUSIONS: Daily treatment with 20 mg of omeprazole was efficient in treating upper abdominal symptoms. Trial registration: ClinicalTrials.gov, number UMIN000002621.
Dyspepsia ; Helicobacter ; Humans ; Japan ; Omeprazole ; Primary Health Care ; Proton Pump Inhibitors ; Proton Pumps ; Protons ; Vomiting