Esomeprazole (NEXIUM) vs. Surgery

Phase 3

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: esomeprazole; Procedure: Laparoscopic fundoplication (surgery)

• Registration Number: NCT00251927
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-10
• Study First Submitted: 2005-11-09
• Study First Submitted QC: 2005-11-09
• Study First Posted: 2005-11-11
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2010-07-08
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-07
• Last Update Submitted: 2012-08-07
• Results First Posted: 2012-08-08
• Last Update Posted: 2012-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 626

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	esomeprazole	Esomeprazole (NEXIUM) therapy
1	Laparoscopic fundoplication (surgery)	Surgery

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Failure at 5 Years	During 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.

Secondary Outcome Measures

Name	Time	Method
Los Angeles (LA) Grade 'Normal' at 5 Year Visit	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
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn	At 5 year visit	Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) Participants with no heartburn
Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit	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
Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit	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
Los Angeles (LA) Grade 'A' at 5 Year Visit	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
Los Angeles (LA) Grade 'B' at 5 Year Visit	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
Los Angeles (LA) Grade C at 5 Year Visit	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
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn	At 5 year visit	Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn	At 5 year visit	Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn	At 5 year visit	Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn

Trial Locations

Locations (1)

Research Site; 🇬🇧 Salford, United Kingdom