Phase 3
N=554
Esomeprazole (NEXIUM) vs. Surgery
Gastroesophageal Reflux
Bottom Line
View on ClinicalTrials.gov: NCT00251927 ↗Enrolled (actual)
554
Serious AEs
37.4%
Results posted
Aug 2012
Primary outcome: Primary: Number of Participants With Treatment Failure at 5 Years — 33; 19 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- esomeprazole (Drug); Laparoscopic fundoplication (surgery) (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Failure at 5 Years |
33; 19 | — |
| SECONDARY Los Angeles (LA) Grade 'Normal' at 5 Year Visit |
144; 158 | — |
| SECONDARY Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn |
163; 161 | — |
| SECONDARY Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit |
0.23; 0.25 | — |
| SECONDARY Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit |
2.9; 4.7 | — |
| SECONDARY Los Angeles (LA) Grade 'A' at 5 Year Visit |
12; 16 | — |
| SECONDARY Los Angeles (LA) Grade 'B' at 5 Year Visit |
5; 7 | — |
| SECONDARY Los Angeles (LA) Grade C at 5 Year Visit |
1; 2 | — |
| SECONDARY Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn |
11; 25 | — |
| SECONDARY Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn |
3; 3 | — |
| SECONDARY Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn |
0; 2 | — |
Summary
The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure.
Eligibility Criteria
Inclusion Criteria
- Subjects considered suitable for surgical treatment and long-term management of esomeprazole.
- History of chronic reflux esophagitis or symptomatic GERD
Exclusion Criteria
- History of esophageal, gastric, or duodenal surgery predicted to influence negatively on subsequent treatment within the study.
- Contraindication to the study drug.
- Pregnancy, lactating or of child-bearing potential.
Data sourced from ClinicalTrials.gov (NCT00251927). 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.