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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
626
40 mg oral tablet administered daily
Surgery
Number of Participants With Treatment Failure at 5 Years
Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.
Time frame: During 5 years
Los Angeles (LA) Grade 'Normal' at 5 Year Visit
Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks \<5 mm in maximal length Grade B - one or more mucosal breaks \>5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between \>2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference
Time frame: At 5 year visit
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn
Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) Participants with no heartburn
Time frame: At 5 year visit
Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit
The total score expressed as a mean of all the scores/number of lesions assessed; scored 2 when erosion/necrosis is found. The score could range from 0 to 2 (maximum severity). Only participants with biopsy at 5 years visit included
Time frame: At 5 year visit
Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit
Intra-gastric acid exposures assessed by 24-h pH-metry. Only participants with pH-emtry performed at 5 year visit included
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Research Site
Linz, Austria
Research Site
Vienna, Austria
Research Site
Zell am See, Austria
Research Site
Brussels, Belgium
Research Site
Brussels (Anderlecht), Belgium
Research Site
Brussels (Woluwé-St-Lambert), Belgium
Research Site
Ghent, Belgium
Research Site
Haine-Saint-Paul, Belgium
Research Site
Leuven, Belgium
Research Site
Liège, Belgium
...and 49 more locations
Time frame: At 5 year visit
Los Angeles (LA) Grade 'A' at 5 Year Visit
Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks \<5 mm in maximal length Grade B - one or more mucosal breaks \>5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between \>2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference
Time frame: At 5 year visit
Los Angeles (LA) Grade 'B' at 5 Year Visit
Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks \<5 mm in maximal length Grade B - one or more mucosal breaks \>5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between \>2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference
Time frame: At 5 year visit
Los Angeles (LA) Grade C at 5 Year Visit
Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks \<5 mm in maximal length Grade B - one or more mucosal breaks \>5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between \>2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference
Time frame: At 5 year visit
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn
Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn
Time frame: At 5 year visit
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn
Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn
Time frame: At 5 year visit
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn
Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn
Time frame: At 5 year visit