Phase 3
Completed N=337
Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis
Refractory Reflux Esophagitis
Source: ClinicalTrials.gov NCT00770913 ↗
Enrolled (actual)
337
Serious AEs
4.2%
Results posted
Apr 2012
Primary outcomePrimary: Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) — 58.8; 78.4; 77.0 Percentage of Participants
Summary
The purpose of this study is to evaluate the efficacy and safety of E3810 tablets in patients with Proton Pump Inhibitor-resistant reflux esophagitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) |
58.8; 78.4; 77.0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have mucosal breaks (erosions, ulcers) on endoscopy and are diagnosed with reflux esophagitis.
- Proton Pump Inhibitor standard dose-resistant reflux esophagitis.
- Patients who are 20 years and older when informed consent is obtained.
Exclusion Criteria
- Patients with a concurrent severe illness, serious heart disease, comorbid severe disease such as hematology, kidney disease, or liver disease.
- Patients with malignancy.
- Patients who are taking another trial drug or the interval between the end of treatment and screening is less than 12 weeks.
Data sourced from ClinicalTrials.gov (NCT00770913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.