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A Study to Prevent Rebleeding After Initial Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer

A Randomised, Double-blind, Parallel-group, Placebo Controlled Study of Esomeprazole i.v. (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour) Administered for 72 Hours to Assess Prevention of Rebleeding in Subjects That Have Undergone Successful Primary Endoscopic Haemostasis of a Bleeding Peptic Ulcer - the PUB Study.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00251979
Enrollment
1312
Registered
2005-11-11
Start date
2005-10-31
Completion date
2007-12-31
Last updated
2011-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Hemorrhage

Brief summary

This study is being carried out to see if constant 3 days infusion of Nexium is effective in preventing rebleeding after an endoscopic treatment.

Interventions

DRUGEsomeprazole

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Signs of a bleeding in the stomach * One endoscopically confirmed bleeding ulcer in the stomach or duodenum

Exclusion criteria

* Malignancy or other advanced disease. * Major cardiovascular event. * Severe hepatic disease

Design outcomes

Primary

MeasureTime frame
Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or PlaceboWithin 72 hours

Secondary

MeasureTime frame
Clinically Significant Rebleeding Within 30 DaysWithin 30 days
Death Within 72 HoursWithin 72 hours
Death Within 30 DaysWithin 30 days
Death Related to Rebleeding Within 30 Days as Judged by the EpCWithin 30 days
Requirement for Surgery Within 72 HoursWithin 72 hours
Clinically Significant Rebleeding Within 7 DaysWithin 7 days
Requirement for Endoscopic Re-treatment Within 72 HoursWithin 72 hours
Requirement for Endoscopic Re-treatment Within 30 DaysWithin 30 days
Number of Blood Units Transfused Within 72 HoursWithin 72 hours
Number of Blood Units Transfused Within 30 Dayswithin 30 days
Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment PeriodWithin 30 days
Requirement for Surgery Within 30 DaysWithin 30 days

Countries

Austria, Denmark, Finland, France, Germany, Greece, Hong Kong, Netherlands, Norway, Romania, Russia, South Africa, Spain, Sweden, Turkey (Türkiye), United Kingdom

Participant flow

Participants by arm

ArmCount
Esomeprazole
Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
375
Placebo
Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
389
Total764

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event1117
Overall StudyDeath35
Overall StudyLost to Follow-up86
Overall StudyProtocol Violation35
Overall StudyWithdrawal by Subject137

Baseline characteristics

CharacteristicEsomeprazolePlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
193 Participants179 Participants372 Participants
Age, Categorical
Between 18 and 65 years
182 Participants210 Participants392 Participants
Sex: Female, Male
Female
121 Participants121 Participants242 Participants
Sex: Female, Male
Male
254 Participants268 Participants522 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
87 / 375129 / 389
serious
Total, serious adverse events
61 / —68 / —

Outcome results

Primary

Clinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo

Time frame: Within 72 hours

ArmMeasureValue (NUMBER)
EsomeprazoleClinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo22 Participants
PlaceboClinically Significant Rebleeding Within 72 Hours of Continous Infusion of Esomeprazole or Placebo40 Participants
Secondary

Clinically Significant Rebleeding Within 30 Days

Time frame: Within 30 days

ArmMeasureValue (NUMBER)
EsomeprazoleClinically Significant Rebleeding Within 30 Days29 Participants
PlaceboClinically Significant Rebleeding Within 30 Days53 Participants
Secondary

Clinically Significant Rebleeding Within 7 Days

Time frame: Within 7 days

ArmMeasureValue (NUMBER)
EsomeprazoleClinically Significant Rebleeding Within 7 Days27 Participants
PlaceboClinically Significant Rebleeding Within 7 Days50 Participants
Secondary

Death Related to Rebleeding Within 30 Days as Judged by the EpC

Time frame: Within 30 days

ArmMeasureValue (NUMBER)
EsomeprazoleDeath Related to Rebleeding Within 30 Days as Judged by the EpC2 Participants
PlaceboDeath Related to Rebleeding Within 30 Days as Judged by the EpC3 Participants
Secondary

Death Within 30 Days

Time frame: Within 30 days

ArmMeasureValue (NUMBER)
EsomeprazoleDeath Within 30 Days3 Participants
PlaceboDeath Within 30 Days8 Participants
Secondary

Death Within 72 Hours

Time frame: Within 72 hours

ArmMeasureValue (NUMBER)
EsomeprazoleDeath Within 72 Hours1 Participants
PlaceboDeath Within 72 Hours0 Participants
Secondary

Number of Blood Units Transfused Within 30 Days

Time frame: within 30 days

ArmMeasureValue (NUMBER)
EsomeprazoleNumber of Blood Units Transfused Within 30 Days589 blood units
PlaceboNumber of Blood Units Transfused Within 30 Days935 blood units
Secondary

Number of Blood Units Transfused Within 72 Hours

Time frame: Within 72 hours

ArmMeasureValue (NUMBER)
EsomeprazoleNumber of Blood Units Transfused Within 72 Hours492 blood units
PlaceboNumber of Blood Units Transfused Within 72 Hours738 blood units
Secondary

Number of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period

Time frame: Within 30 days

ArmMeasureValue (NUMBER)
EsomeprazoleNumber of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period284 days
PlaceboNumber of Days Hospitalized Due to Rebleeding During the 30-day Treatment Period500 days
Secondary

Requirement for Endoscopic Re-treatment Within 30 Days

Time frame: Within 30 days

ArmMeasureValue (NUMBER)
EsomeprazoleRequirement for Endoscopic Re-treatment Within 30 Days24 Participants
PlaceboRequirement for Endoscopic Re-treatment Within 30 Days45 Participants
Secondary

Requirement for Endoscopic Re-treatment Within 72 Hours

Time frame: Within 72 hours

ArmMeasureValue (NUMBER)
EsomeprazoleRequirement for Endoscopic Re-treatment Within 72 Hours16 Participants
PlaceboRequirement for Endoscopic Re-treatment Within 72 Hours32 Participants
Secondary

Requirement for Surgery Within 30 Days

Time frame: Within 30 days

ArmMeasureValue (NUMBER)
EsomeprazoleRequirement for Surgery Within 30 Days10 Participants
PlaceboRequirement for Surgery Within 30 Days21 Participants
Secondary

Requirement for Surgery Within 72 Hours

Time frame: Within 72 hours

ArmMeasureValue (NUMBER)
EsomeprazoleRequirement for Surgery Within 72 Hours5 Participants
PlaceboRequirement for Surgery Within 72 Hours9 Participants

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026