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Therapeutic study of the proton- pump inhibitors resistant patients with Non-Erosive Reflux Disease

Therapeutic study of the proton- pump inhibitors resistant patients with Non-Erosive Reflux Disease

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82345975
Enrollment
80
Registered
2007-10-11
Start date
2007-06-01
Completion date
Unknown
Last updated
2021-08-02

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

Conditions

Non-Erosive Reflux Disease (NERD) Digestive System Non-Erosive Reflux Disease (NERD)

Interventions

After being treated with lansoprazole 15 mg/day for 4 weeks, the NERD patients who do not show reduction in their symptoms (more than 6 points diagnosed by the QUEST questionnaire or below 50% improve

Sponsors

Shimane University, Second Department of Internal Medicine (Japan)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 20 and over 2. Heartburn (more than 6 points diagnosed by the Japanese version of questionnaire for the diagnosis of reflux disease [QUEST]) 3. Signed a study-specific informed consent form

Exclusion criteria

Exclusion criteria: 1. Endoscopic esophagitis 2. Gastric and duodenal ulcers, stomach cancer, or acute gastritis 3. Known hypersensitivity to rebamipide 4. Catastrophic complications 5. Pregnancy or desire to become pregnant 6. Judged inappropriate for this study by the physicians

Design outcomes

Primary

MeasureTime frame
The subjective symptoms are assessed by the Japanese version QUEST and Gastrointestinal Symptom Rating Scale (GSRS). The assessment by GSRS is limited to upper gastrointestinal tract questions. These will be measured at baseline, 1 month after PPI therapy and 1 month after repamipide or placebo.

Secondary

MeasureTime frame
Number of patients who complete the study protocol.

Countries

Japan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026