An Efficacy Study of Esomeprazole in Patients with Reflux Esophagitis Poorly Responsive to Lansoprazole

Not Applicable

• Conditions: reflux esophagitis

• Registration Number: JPRN-UMIN000008780
• Lead Sponsor: Research Organization for Gastroenterological Disease Treatment

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-01
• Study Completion: 2014-07-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Patients with a history of hypersensitivity to the study drugs. (2) Patients with a history of digestive tract resection or vagotomy. (3) Patients with warning findings such as vomiting, gastrointestinal hemorrhage (including findings such as hematemesis, melena, and anemia) and acute weight loss. (4) Patients with concurrent peptic ulcer (excluding the scarred stage). (5) Patients with a past or current history of any of the following diseases: Zollinger-Ellison syndrome, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), esophageal stenosis, esophageal achalasia, malabsorption, or cerebrovascular disorder such as cerebral hemorrhage and cerebral infarction. (6) Patients treated for H. pylori eradication within 6 months before the time of eligibility check. (7) Patients who may have difficulty participating in the study owing to serious complications such as liver, renal, or cardiac diseases. (8) Patients with a confirmed or possible malignancy. (9) Women who are pregnant, lactating, or possibly pregnant. (10) Patients who are on proton pump inhibitors other than lansoprazole. (11) Patients who need to continue treatment with drugs for which interactions with the study drugs are anticipated. (12) Patients who are on or need to continue treatment with drugs that are assumed to have an effect on study results. *However, patients may be enrolled in the study if such drugs are interrupted for 1 week prior to the investigation of the symptoms or are switched to other treatment. (13) Patients who are determined by the investigator or subinvestigator to be not suitable to be enrolled in the study due to other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in the number of days the patient reported reflux symptoms (heartburn or acid reflux) from the baseline to that during the 1-week period immediately before Week 4.