Trial · NCT02157376

Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

NCT02157376, Phase 3, Completed, AstraZeneca; results first posted 2017-01-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients. Trials, record NCT02157376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02157376

On this page

Trial

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

Title: Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients
NCT number: NCT02157376
Status: Completed
Phases: Phase 3
Enrollment: 343 participants, actual
Lead sponsor: AstraZeneca
Conditions: Stress Ulcer Prophylaxis
Interventions: Esomeprazole, Cimetidine
First posted: 2014-06-06
Last updated: 2017-03-10
Results first posted: 2017-01-23

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase	1-14 days	Criteria for a clinically significant upper GI bleeding as: 1. Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of at least 100 ml lavage with room temperature normal saline-or, 2. Persistent gastroccult- positive coffee ground material During IMP treatment Day 1-2: Persistent gastroccult- positive coffee ground material for at least eight consecutive hours that did not clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult- positive coffee ground material in at least three consecutive gastric aspirates within 2 to 4 hours (at least 60 ±20 minutes apart), that did not clear with at least 100 ml of lavage with room temperature normal saline.
Secondary	Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase	1-14 days	Criteria for a significant upper GI bleeding as described in primary outcome measure or, Criteria for a non-significant upper GI bleeding as: 1. Bright red blood per NG or OG tube that clear after NG or OG tube adjustment and 5 to 10 minutes of lavage with room temperature normal saline or, 2. Persistent gastroccult- positive coffee ground material During IMP treatment Day 1-2: Persistent gastroccult - positive coffee ground material for at less than eight consecutive hours or that clear with at least 100 ml of lavage with room temperature normal saline. During IMP treatment Day 3-14: Persistent gastroccult - positive coffee ground material in less than three consecutive gastric aspirates within 2 to 4 hours (at least 60±20 minutes apart), or that clear with at least 100 ml of lavage with room temperature normal saline or, 3. Any clinical signs of hematemesis or melena or haematochezia judged (by the Investigator) to be from an upper GI source.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase	1-14 days	Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated.	% of participants	NUMBER
SECONDARY	Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase	1-14 days	Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated.	proportion of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Units
The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase	Esomeprazole	2.7	% of participants
The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase	Cimetidine	4.6	% of participants
Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase	Esomeprazole	0.109	proportion of participants
Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase	Cimetidine	0.105	proportion of participants

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Esomeprazole	155
Overall Study	STARTED	Cimetidine	156
Overall Study	COMPLETED	Esomeprazole	133
Overall Study	COMPLETED	Cimetidine	138
Overall Study	NOT COMPLETED	Esomeprazole	22
Overall Study	NOT COMPLETED	Cimetidine	18

Source ClinicalTrials.gov

Adverse events64

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	Events
other	Anaemia	Blood and lymphatic system disorders	Cimetidine	15	153	15
other	Anaemia	Blood and lymphatic system disorders	Esomeprazole	13	147	13
other	Constipation	Gastrointestinal disorders	Cimetidine	14	153	15
other	Constipation	Gastrointestinal disorders	Esomeprazole	8	147	11
other	Upper gastrointestinal haemorrhage	Gastrointestinal disorders	Cimetidine	10	153	13
other	Upper gastrointestinal haemorrhage	Gastrointestinal disorders	Esomeprazole	6	147	7
other	Pyrexia	General disorders	Cimetidine	25	153	31
other	Pyrexia	General disorders	Esomeprazole	27	147	31
other	Hepatic function abnormal	Hepatobiliary disorders	Cimetidine	10	153	10
other	Hepatic function abnormal	Hepatobiliary disorders	Esomeprazole	9	147	9

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cimetidine
Total, all-cause mortality	Esomeprazole
Total, other adverse events	Cimetidine	88	153
Total, other adverse events	Esomeprazole	85	147
Total, serious adverse events	Cimetidine	12	153
Total, serious adverse events	Esomeprazole	14	147

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29638148	DERIVED

Source 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 comparisons1

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

Comparison
Cimetidine vs Esomeprazole: serious adverse events

Source 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/NCT02157376

GET https://conductscience.org/api/trials/v1/NCT02157376/events?page=2

API reference For AI assistants