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*

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*

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: 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

PURPOSE: The aims of this study are to investigate the effect of the eradication of H. pylori on histological change of gastric mucosa in children with H. pylori gastritis and to determine whether the histological grading by the Sydney system is valuable in predicting the effect of treatment. METHODS: 1) Histological scores by the Sydney system and the endoscopic characteristics were assessed before and at least four weeks after anti-H. pylori therapy in 42 children with H. pylori gastritis. 2) In 32 children treated with omeprazole, amoxicillin and clarithromycin (OAC), pretreatment histological scores and endoscopic findings were compared between the eradicated and the noneradicated to evaluate their predictive value for the successful eradication. RESULTS: 1) In the eradicated (27 cases), nodular gastritis significantly decreased from 89% to 63% (p<0.05). There was an significant improvement in the mean activity score from 2.06 before treatment to 0.24 after treatment (p<0.01). The mean inflammatory score also improved from 2.61 before treatment to 1.89 after treatment (p<0.05). Lymphoid follicles significantly decreased from 48% to 15% (p<0.05). Epithelial damage improved in all 4 cases. But in the noneradicated (15 cases), there was no significant change in the frequency of nodular gastritis, the mean activity score, the mean inflammatory score and the frequency of the lymphoid follicles. 2) In 32 children treated with OAC, there was a tendency that the higher was the pretreatment score of the bacterial density, the lower was the eradication rate of H. pylori (p=0.072). CONCLUSION: The loss of the polymorphonuclear cell infiltration is the most prominent histological change after successful eradication. There may be negative correlation of the grade of the bacterial density with the success rate of the anti-H. pylori therapy.
Amoxicillin ; Child* ; Clarithromycin ; Gastric Mucosa ; Gastritis* ; Helicobacter pylori* ; Helicobacter* ; Humans ; Omeprazole

PURPOSE: Gastroesophageal reflux disease (GERD) occurs in pediatric patients when reflux of gastric contents presents with troublesome symptoms. The present study compared the effects of omeprazole and ranitidine for the treatment of symptomatic GERD in infants of 2-12 months. METHODS: This study was a clinical randomized double-blind trial and parallel-group comparison of omeprazole and ranitidine performed at Children Training Hospital in Tabriz, Iran. Patients received a standard treatment for 2 weeks. After 2 weeks, the patients with persistent symptoms were enrolled in this randomized study. RESULTS: We enrolled 76 patients in the present study and excluded 16 patients. Thirty patients each were included in group A (ranitidine) and in group B (omeprazole). GERD symptom score for groups A and B was 47.17±5.62 and 51.93±5.42, respectively, with a P value of 0.54, before the treatment and 2.47±0.58 and 2.43±1.15, respectively, after the treatment (P=0.98). No statistically significant differences were found between ranitidine and omeprazole in their efficacy for the treatment of GERD. CONCLUSION: The safety and efficacy of ranitidine and omeprazole have been demonstrated in infants. Both groups of infants showed a statistically significant decrease in the score of clinical variables after the treatment.
Child ; Gastroesophageal Reflux* ; Humans ; Infant* ; Iran ; Omeprazole ; Proton Pump Inhibitors* ; Proton Pumps* ; Protons* ; Ranitidine