Trial · NCT01757275

High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer

NCT01757275, Phase 3, Completed, AstraZeneca; results first posted 2016-03-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer. Trials, record NCT01757275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01757275

On this page

Trial

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

Title: High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer
NCT number: NCT01757275
Status: Completed
Phases: Phase 3
Enrollment: 239 participants, actual
Lead sponsor: AstraZeneca
Conditions: Bleeding Peptic Ulcer
Interventions: Esomeprazole Na, Cimetidine, Esomeprazole Mg
First posted: 2012-12-28
Last updated: 2016-03-08
Results first posted: 2016-03-08
Limitations and caveats: No hypothesis testing was performed in this study and, as such, no formal statistical comparisons were made. Two patients who were initially randomised to receive cimetidine treatment actually received esomeprazole treatment.

Source ClinicalTrials.gov

Registered outcomes9

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

List	Outcome	Time frame	Description
Primary	Rate of Clinically Significant Rebleeding Within 72 Hours	72 hours	Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb \>20g/L (or Hct \>6%) during 24 hours or an increase in Hb \<10g/L (or Hct \<3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (\>200 ml) of fresh blood as estimated by the investigator.
Secondary	Rate of Clinically Significant Rebleeding During 7 Days	7 days	Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb \>20g/L (or Hct \>6%) during 24 hours or an increase in Hb \<10g/L (or Hct \<3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (\>200 ml) of fresh blood as estimated by the investigator.
Secondary	Rate of Clinically Significant Rebleeding During 30 Days	30 days	Diagnostic criteria for clinically significant rebleeding based on either A, B or C: A) Endoscopy - initiated by clinical signs of bleeding defined as one of B1 or B2 or B3 and endoscopic verification, ie one of A1 or A2. A1: Blood in stomach (this criteria cannot be used during the first 6 hours after primary endoscopic haemostasis). A2: A verified active bleeding from a peptic ulcer (Forrest Ia, Ib). B) A true clinically based definition, at least two of B1 and/or B2 and/or B3. B1: Vomiting of fresh blood or fresh blood in a gastric tube or haematochezia or melaena after a normal stool. B2: Decrease in Hb \>20g/L (or Hct \>6%) during 24 hours or an increase in Hb \<10g/L (or Hct \<3%) despite ≥2 units of blood has been transfused during 24hours. B3: Unstable circulation systolic blood pressure ≤ 90 mmHg or pulse ≥110/min (after have had a stable circulation). C) Haematemesis. Vomiting significant amounts (\>200 ml) of fresh blood as estimated by the investigator.
Secondary	Number of Patients With Endoscopic Re-treatment Within 72 Hours	72 hours
Secondary	Number of Patients With Endoscopic Re-treatment Within 30 Days	30 days
Secondary	Number of Patients With Surgery Due to Rebleeding Within 72 Hours	within 72 hours
Secondary	Number of Patients With Surgery Due to Rebleeding Within 30 Days	within 30 days
Secondary	Number of Blood Units Transfused Within 72 Hours	within 72 hours
Secondary	Number of Blood Units Transfused Within 30 Days	within 30 days

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Rate of Clinically Significant Rebleeding Within 72 Hours	72 hours	Full analysis set (FAS). All randomised patients, who started the randomised iv treatment (bolus dose), were included in the FAS.	participants	NUMBER
SECONDARY	Rate of Clinically Significant Rebleeding During 7 Days	7 days	FAS	participants	NUMBER
SECONDARY	Rate of Clinically Significant Rebleeding During 30 Days	30 days	FAS	participants	NUMBER
SECONDARY	Number of Patients With Endoscopic Re-treatment Within 72 Hours	72 hours	FAS	participants	NUMBER
SECONDARY	Number of Patients With Endoscopic Re-treatment Within 30 Days	30 days	FAS	participants	NUMBER
SECONDARY	Number of Patients With Surgery Due to Rebleeding Within 72 Hours	within 72 hours	FAS	participants	NUMBER
SECONDARY	Number of Patients With Surgery Due to Rebleeding Within 30 Days	within 30 days	FAS	participants	NUMBER
SECONDARY	Number of Blood Units Transfused Within 72 Hours	within 72 hours	FAS	blood units	NUMBER
SECONDARY	Number of Blood Units Transfused Within 30 Days	within 30 days	FAS	blood units	NUMBER

Source ClinicalTrials.gov

Results by group32

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

Outcome	Group	Category	Value	Units
Rate of Clinically Significant Rebleeding Within 72 Hours	Esomeprazole	No rebleeding	107	participants
Rate of Clinically Significant Rebleeding Within 72 Hours	Cimetidine	No rebleeding	101	participants
Rate of Clinically Significant Rebleeding Within 72 Hours	Esomeprazole	Rebleeding	1	participants
Rate of Clinically Significant Rebleeding Within 72 Hours	Cimetidine	Rebleeding	6	participants
Rate of Clinically Significant Rebleeding During 7 Days	Esomeprazole	No rebleeding	105	participants
Rate of Clinically Significant Rebleeding During 7 Days	Cimetidine	No rebleeding	101	participants
Rate of Clinically Significant Rebleeding During 7 Days	Esomeprazole	Rebleeding	3	participants
Rate of Clinically Significant Rebleeding During 7 Days	Cimetidine	Rebleeding	6	participants
Rate of Clinically Significant Rebleeding During 30 Days	Esomeprazole	No rebleeding	105	participants
Rate of Clinically Significant Rebleeding During 30 Days	Cimetidine	No rebleeding	101	participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Esomeprazole	111
Overall Study	STARTED	Cimetidine	111
Overall Study	COMPLETED	Esomeprazole	102
Overall Study	COMPLETED	Cimetidine	98
Overall Study	NOT COMPLETED	Esomeprazole	9
Overall Study	NOT COMPLETED	Cimetidine	13

Source ClinicalTrials.gov

Adverse events118

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
other	Bronchitis	Infections and infestations	Esomeprazole	0	110
other	Bronchitis	Infections and infestations	Cimetidine	1	105
other	Nasopharyngitis	Infections and infestations	Esomeprazole	1	110
other	Nasopharyngitis	Infections and infestations	Cimetidine	0	105
other	Upper respiratory tract infection	Infections and infestations	Esomeprazole	0	110
other	Upper respiratory tract infection	Infections and infestations	Cimetidine	1	105
other	Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Esomeprazole	1	110
other	Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Cimetidine	0	105
other	Anaemia	Blood and lymphatic system disorders	Esomeprazole	0	110
other	Anaemia	Blood and lymphatic system disorders	Cimetidine	1	105

1 to 10 of 118Source ClinicalTrials.gov

See all 118 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Esomeprazole
Total, all-cause mortality	Cimetidine
Total, other adverse events	Esomeprazole	22	110
Total, other adverse events	Cimetidine	20	105
Total, serious adverse events	Esomeprazole	5	110
Total, serious adverse events	Cimetidine	5	105

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26581750	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
Esomeprazole vs Cimetidine: 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/NCT01757275

GET https://conductscience.org/api/trials/v1/NCT01757275/results?page=2

API reference For AI assistants