Phase 3
Completed N=495
A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
Erosive Esophagitis
Source: ClinicalTrials.gov NCT01499368 ↗
Enrolled (actual)
495
Serious AEs
0.6%
Results posted
Sep 2020
Primary outcomePrimary: Recovery Rates of Reflux Esophagitis — 101; 92; 126; 43 Participants — p=0.05
Summary
To evaluate the healing rate and safety of Lafutidine in erosive esophagitis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovery Rates of Reflux Esophagitis |
101; 92; 126; 43; 53; 21 | 0.05 |
| SECONDARY The Proportion of Days Without 'Cardinal Symptom' |
0.64; 0.56; 0.69; 0.77; 0.67; 0.82 | 0.05 |
| SECONDARY The Proportion of Daytimes Without 'Cardinal Symptom' |
0.74; 0.68; 0.77; 0.83; 0.76; 0.87 | — |
| SECONDARY The Proportion of Nighttimes Without 'Cardinal Symptom' |
0.75; 0.72; 0.82; 0.87; 0.78; 0.89 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification
Exclusion Criteria
- Gastric or duodenal ulcers (excluding ulcer scars)
- Concurrent presence of Barrett's esophagus
- A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks
- Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety
Data sourced from ClinicalTrials.gov (NCT01499368). 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.