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Clinical Trials/JPRN-UMIN000003078
JPRN-UMIN000003078
Completed
未知

Study of the improvement effect of proton pump inhibitors on symptoms in patients with reflux esophagitis (RE): a randomized comparative study of omeprazole 20mg vs. rabeprazole 10mg using the time (number of days) to improvement in symptoms as an index - Study of the improvement effect of proton pump inhibitors on symptoms in patients with reflux esophagitis

Japan Dyspepsia Society0 sites220 target enrollmentJanuary 25, 2010

Overview

Phase
未知
Intervention
Not specified
Conditions
patients with reflux esophagitis
Sponsor
Japan Dyspepsia Society
Enrollment
220
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 25, 2010
End Date
March 1, 2011
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Japan Dyspepsia Society

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • (1\)Patients with a history of gastrointestinal resection or vagotomy (2\)Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia), and sudden weight loss (3\)Patients with peptic ulcer (except those in scarring stage) (4\)Patients with a history of, or who currently have, any of the following diseases: \&\#8226;Zollinger\-Ellison syndrome \&\#8226;Inflammatory Bowel Disease (IBD) \&\#8226;Irritable Bowel Syndrome (IBS) \&\#8226;Esophageal stricture \&\#8226;Esophageal achalasia \&\#8226;Malabsorption \&\#8226;Cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction (5\)Patients whose participation in this study would be contraindicated due to complications such as serious hepatic disease, renal disease, or cardiac disease. (6\)Patients with a confirmed, or suspected, malignant lesion (7\)Women who are pregnant or who may possibly be pregnant, and lactating mothers (8\)Patients who require continued treatment with drugs (atazanavir sulfate, diazepam, phenytoin, warfarin, tacrolimus hydrate, digoxin, methyldigoxin, itraconazole, gefitinib, voriconazole, and antacids containing aluminium hydroxide gel and magnesium hydroxide) which may interact with the study drugs (9\)Patients receiving treatment with proton pump inhibitors, H2\-receptor antagonists, prokinetic agents, gastric mucosa protective agents, anticholinergics, antacids, antidepressants, antianxiety agents, antidiabetic drugs, steroids (excluding external preparations), non\-steroid anti\-inflammatory drugs (NSAIDs), aspirin preparations including low\-dose aspirin and/or bisphosphonate drugs. However, patients who discontinue using these drugs for at least 1 week prior to the symptom survey or switch to another treatment, may enrol in the study. (10\)Other patients whom the investigator considers unsuitable for admission to the study

Outcomes

Primary Outcomes

Not specified

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