Phase 3
Completed N=564
Reflux Esophagitis Phase III Study (Maintenance Treatment)
Reflux Esophagitis
Source: ClinicalTrials.gov NCT00634114 ↗
Enrolled (actual)
564
Serious AEs
1.8%
Results posted
Jun 2010
Primary outcomePrimary: Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. — 174; 166; 156 Participants
Summary
The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. |
174; 166; 156 | — |
| SECONDARY Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment |
184; 180; 171 | — |
| SECONDARY Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment |
179; 172; 163 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with healed Reflux Esophagitis verified by EGD in the preceding study (D961HC00002)
- Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving general treatment with PPI
Exclusion Criteria
- Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation.
- Use of any PPI from 14 days before EGD performed at the screening visit to the day of randomisation.
Data sourced from ClinicalTrials.gov (NCT00634114). 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.