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A fact-finding study on the treatment of gastroesophageal reflux disease (GERD) - Prospective study on therapeutic effects of proton pump inhibitors on reflux esophagitis -

A fact-finding study on the treatment of gastroesophageal reflux disease (GERD) - Prospective study on therapeutic effects of proton pump inhibitors on reflux esophagitis - - A prospective fact-finding study on the treatment of gastroesophageal reflux disease (GERD)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000005271
Enrollment
120
Registered
2011-03-18
Start date
2011-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroesophageal reflux disease (GERD)

Interventions

None listed

Sponsors

GERD Society
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who have provided written consent of their own free will to participate in the study after receiving sufficient written and verbal information about the study 2) Patients of both sexes aged 20 years or above. 3) Patients endoscopically diagnosed with Grade C or D reflux esophagitis according to the LA classification

Exclusion criteria

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), or sudden weight loss 3) Patients with concurrent peptic ulcer (not in the scarring stage) 4) Patients with a prior or current history of any of the following diseases: - Zollinger-Ellison syndrome - Inflammatory bowel disease (IBD) - Irritable bowel syndrome (IBS) - Esophageal stricture - Eosinophilic reflux esophagitis - Esophageal achalasia - Malabsorption - Cerebrovascular disorders such as cerebral hemorrhage and cerebral infarction 5) Patients complicated by serious hepatic, renal, cardiac, or other diseases for which the participation in the study would be difficult 6) Patients with a confirmed or suspected malignant lesion 7) Patients who are pregnant, breastfeeding, or may be pregnant 8) Patients considered to require continued use of any drugs that could interact with the study drugs (i.e., atazanavir sulfate, diazepam, phenytoin, warfarin, tacrolimus hydrate, digoxin, methyldigoxin, itraconazole, gefitinib, voriconazole, antacids containing aluminium hydroxide gel and magnesium hydroxide, and clopidogrel) 9) Patients with a history of hypersensitivity to any components of proton pump inhibitor products 10) Patients who received a proton pump inhibitor within a week prior to endoscopy 11) Other patients judged by the physician to be inappropriate for this study

Design outcomes

Primary

MeasureTime frame
Esophageal endoscopic findings according to the LA classification

Secondary

MeasureTime frame
- Frequency and severity of acid reflux-related symptoms (heartburn, acid regurgitation) and dyspepsia-related symptoms (heavy stomach feeling, early satiety, epigastralgia, epigastric burning sensation) - Factors that may affect healing of lesions

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026