Trial · NCT00251927

Esomeprazole (NEXIUM) vs. Surgery

NCT00251927, Phase 3, Completed, AstraZeneca; results first posted 2012-08-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Esomeprazole (NEXIUM) vs. Surgery. Trials, record NCT00251927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00251927

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Esomeprazole (NEXIUM) vs. Surgery
NCT number: NCT00251927
Status: Completed
Phases: Phase 3
Enrollment: 626 participants, actual
Lead sponsor: AstraZeneca
Conditions: Gastroesophageal Reflux
Interventions: esomeprazole, Laparoscopic fundoplication (surgery)
First posted: 2005-11-11
Last updated: 2012-08-08
Results first posted: 2012-08-08

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants With Treatment Failure at 5 Years	During 5 years	participants	NUMBER
SECONDARY	Los Angeles (LA) Grade 'Normal' at 5 Year Visit	At 5 year visit	participants	NUMBER
SECONDARY	Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn	At 5 year visit	participants	NUMBER
SECONDARY	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	units on a scale	MEAN
SECONDARY	Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit	At 5 year visit	percentage of time recorded	MEAN
SECONDARY	Los Angeles (LA) Grade 'A' at 5 Year Visit	At 5 year visit	participants	NUMBER
SECONDARY	Los Angeles (LA) Grade 'B' at 5 Year Visit	At 5 year visit	participants	NUMBER
SECONDARY	Los Angeles (LA) Grade C at 5 Year Visit	At 5 year visit	participants	NUMBER
SECONDARY	Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn	At 5 year visit	participants	NUMBER
SECONDARY	Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn	At 5 year visit	participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Treatment Failure at 5 Years	Esomeprazole Surgical Arm	33		participants
Number of Participants With Treatment Failure at 5 Years	Esomeprazole Medical Arm	19		participants
Los Angeles (LA) Grade 'Normal' at 5 Year Visit	Esomeprazole Surgical Arm	144		participants
Los Angeles (LA) Grade 'Normal' at 5 Year Visit	Esomeprazole Medical Arm	158		participants
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn	Esomeprazole Surgical Arm	163		participants
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn	Esomeprazole Medical Arm	161		participants
Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit	Esomeprazole Surgical Arm	0.23	Standard Error 0.10	units on a scale
Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit	Esomeprazole Medical Arm	0.25	Standard Error 0.03	units on a scale
Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit	Esomeprazole Surgical Arm	2.9	Standard Deviation 7.0	percentage of time recorded
Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit	Esomeprazole Medical Arm	4.7	Standard Deviation 7.0	percentage of time recorded

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Esomeprazole Surgical Arm	288
Overall Study	STARTED	Esomeprazole Medical Arm	266
Overall Study	COMPLETED	Esomeprazole Surgical Arm	180
Overall Study	COMPLETED	Esomeprazole Medical Arm	192
Overall Study	NOT COMPLETED	Esomeprazole Surgical Arm	108
Overall Study	NOT COMPLETED	Esomeprazole Medical Arm	74

Source ClinicalTrials.gov

Adverse events447

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	Microcytic Anaemia	Blood and lymphatic system disorders	Esomeprazole Surgical Arm	0	248
serious	Microcytic Anaemia	Blood and lymphatic system disorders	Esomeprazole Medical Arm	1	266
serious	Microcytic Anaemia	Blood and lymphatic system disorders	Non-Surgical Arm	0	40
serious	Acute Myocardial Infarction	Cardiac disorders	Esomeprazole Surgical Arm	0	248
serious	Acute Myocardial Infarction	Cardiac disorders	Esomeprazole Medical Arm	2	266
serious	Acute Myocardial Infarction	Cardiac disorders	Non-Surgical Arm	0	40
serious	Angina Pectoris	Cardiac disorders	Esomeprazole Surgical Arm	1	248
serious	Angina Pectoris	Cardiac disorders	Esomeprazole Medical Arm	3	266
serious	Angina Pectoris	Cardiac disorders	Non-Surgical Arm	0	40
serious	Arrhythmia	Cardiac disorders	Esomeprazole Surgical Arm	0	248

1 to 10 of 447Source ClinicalTrials.gov

See all 447 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Esomeprazole Surgical Arm
Total, all-cause mortality	Esomeprazole Medical Arm
Total, all-cause mortality	Non-Surgical Arm
Total, other adverse events	Esomeprazole Surgical Arm	0	248
Total, other adverse events	Esomeprazole Medical Arm	0	266
Total, other adverse events	Non-Surgical Arm	0	40
Total, serious adverse events	Esomeprazole Surgical Arm	103	248
Total, serious adverse events	Esomeprazole Medical Arm	101	266
Total, serious adverse events	Non-Surgical Arm	3	40

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21586712	DERIVED	PubMed
22998687	DERIVED	PubMed
25350223	DERIVED	PubMed
25858519	DERIVED	PubMed
26226096	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons9

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Esomeprazole Surgical Arm vs Esomeprazole Medical Arm: Los Angeles (LA) Grade 'B' at 5 Year Visit	Trial comparisons
Esomeprazole Surgical Arm vs Esomeprazole Medical Arm: Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn	Trial comparisons
Esomeprazole Surgical Arm vs Esomeprazole Medical Arm: Los Angeles (LA) Grade 'Normal' at 5 Year Visit	Trial comparisons
Esomeprazole Surgical Arm vs Esomeprazole Medical Arm: Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn	Trial comparisons
Esomeprazole Surgical Arm vs Esomeprazole Medical Arm: Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn	Trial comparisons
Esomeprazole Surgical Arm vs Esomeprazole Medical Arm: Number of Participants With Treatment Failure at 5 Years	Trial comparisons
Esomeprazole Surgical Arm vs Esomeprazole Medical Arm: Los Angeles (LA) Grade 'A' at 5 Year Visit	Trial comparisons
Esomeprazole Surgical Arm vs Esomeprazole Medical Arm: Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn	Trial comparisons
Esomeprazole Surgical Arm vs Esomeprazole Medical Arm: Los Angeles (LA) Grade C at 5 Year Visit	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00251927

GET https://conductscience.org/api/trials/v1/NCT00251927/results?page=2

API reference For AI assistants