Bleeding Peptic UlcerPhase 3NCT01757275

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

A Phase 3 study testing Esomeprazole Na, Cimetidine and Esomeprazole Mg in people with Bleeding Peptic Ulcer, run by AstraZeneca at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Bleeding Peptic Ulcer
What is being tested?: Esomeprazole Na, Cimetidine and Esomeprazole Mg
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 239 participants
Where: 12 sitesChina
Study dates: Feb 2013to Dec 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent prior to any study specific procedures.
Female or male aged =18 years and =70 years.
Acute upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or such signs within the last 24 hours as judged by the investigator.
One endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm in diameter, classified as Forrest Ia, Ib, IIa, or IIb. Photo documentation of the source of bleeding should be provided.
Successful haemostasis (which is considered to have been established if bleeding has stopped and, if applicable, formerly bleeding vessels are flattened or cavitated) achieved by endoscopic treatment and confirmed by site staff.

Who cannot join

Endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the investigator.
Sign of multi PUB or concomitant other gastro bleeding from esophageal varices, reflux esophagitis, gastritis, Mallory Weiss rifts, ulcus simplex, Dieulafoy's lesion, colon, small bowel, or ulcer distal to the stom in Billroth-resected patients.
Need for treatment during the first 7 days of the study with NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, acetyl salicylic acid (ASA) (including low dose) or clopidogrel.
Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
Chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned during the course of the study.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

China12 sites

Research Site
Beijing
Research Site
Changsha
Research Site
Chongqing
Research Site
Guangzhou
Research Site
Ha'er Bing
Research Site
Hangzhou
Research Site
Jinan
Research Site
Nanchang
Research Site
Nanjing
Research Site
Shanghai
Research Site
Wuhan
Research Site
Xi'an

Other trials in China

About this study

Official title: A Multi-center, Randomised, Double-blind, Parallel-group Phase III Study to Assess High Dose Esomeprazole Na i.v. Treatment (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour Administered for 72 Hours) for Prevention of Rebleeding

Read the detailed description

A multi-center, randomised, double-blind, parallel-group phase III study to assess high dose esomeprazole Na i.v. treatment (bolus infusion of 80 mg followed by a continuous infusion of 8 mg per hour administered for 72 hours) for prevention of rebleeding

Conditions: Bleeding Peptic Ulcer
Being tested: Esomeprazole Na, Cimetidine, Esomeprazole Mg
Keywords: peptic ulcer bleeding, prevention of rebleeding, successful endoscopic haemostatic therapy
Medical subject headings: Peptic Ulcer Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Esomeprazole NaDrug
Also called Nexium
Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous
CimetidineDrug
Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours
Esomeprazole MgDrug
Also called Nexium
40 mg tablet once daily for 27 days

Study groups in NCT01757275
Study group	Role	What they receive
Esomeprazole	Experimental	Not described Receives: Drug: Esomeprazole Na; Drug: Esomeprazole Mg
Cimetidine	Active comparator	Not described Receives: Drug: Cimetidine

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Clinically Significant Rebleeding Within 72 Hours
Diagnostic criteria for clinically significant rebleeding based on either A, B or C:
1. 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).
1. 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).
2. Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator.
Measured: 72 hours

Secondary outcomes (8)

Rate of Clinically Significant Rebleeding During 7 Days
Diagnostic criteria for clinically significant rebleeding based on either A, B or C:
1. 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).
1. 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).
2. Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator.
Measured: 7 days
Rate of Clinically Significant Rebleeding During 30 Days
Diagnostic criteria for clinically significant rebleeding based on either A, B or C:
1. 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).
1. 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).
2. Haematemesis. Vomiting significant amounts (>200 ml) of fresh blood as estimated by the investigator.
Measured: 30 days
Number of Patients With Endoscopic Re-treatment Within 72 Hours
Measured: 72 hours
Number of Patients With Endoscopic Re-treatment Within 30 Days
Measured: 30 days
Number of Patients With Surgery Due to Rebleeding Within 72 Hours
Measured: within 72 hours
Number of Patients With Surgery Due to Rebleeding Within 30 Days
Measured: within 30 days
Number of Blood Units Transfused Within 72 Hours
Measured: within 72 hours
Number of Blood Units Transfused Within 30 Days
Measured: within 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Dec 2014

First posted28 Dec 2012 (estimated)
Study startFeb 2013
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bleeding Peptic UlcerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01757275
Sponsor's protocol ID: D961DC00007
Status last verified: Feb 2016
First submitted: 21 Dec 2012
Last updated: 8 Mar 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Bai Y, Chen DF, Wang RQ, Chen YX, Shi RH, Tian DA, Chen H, Eklund S, Li ZS; Chinese Peptic Ulcer Bleeding Research Group. Intravenous Esomeprazole for Prevention of Peptic Ulcer Rebleeding: A Randomized Trial in Chinese Patients. Adv Ther. 2015 Nov;32(11):1160-76. doi: 10.1007/s12325-015-0265-6. Epub 2015 Nov 18.
PubMed 26581750

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bleeding Peptic Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Randomised, Double-blind, Parallel-group Phase III Study to Assess High Dose Esomeprazole Na i.v. Treatment (Bolus Infusion of 80 mg Followed by a Continuous Infusion of 8 mg Per Hour Administered for 72 Hours) for Prevention of Rebleeding
ClinicalTrials.gov ID: NCT01757275
Acronym / sponsor ID: D961DC00007
Conditions: Bleeding Peptic Ulcer
Keywords: peptic ulcer bleeding, prevention of rebleeding, successful endoscopic haemostatic therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 239 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 28 Dec 2012 (estimated)
Results: Posted 8 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Esomeprazole	Experimental	Drug: Esomeprazole Na, Drug: Esomeprazole Mg
Cimetidine	Active comparator	Drug: Cimetidine

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provision of informed consent prior to any study specific procedures.
Female or male aged =18 years and =70 years.
Acute upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or such signs within the last 24 hours as judged by the investigator.
One endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm in diameter, classified as Forrest Ia, Ib, IIa, or IIb. Photo documentation of the source of bleeding should be provided.
Successful haemostasis (which is considered to have been established if bleeding has stopped and, if applicable, formerly bleeding vessels are flattened or cavitated) achieved by endoscopic treatment and confirmed by site staff.

Key exclusion criteria (5 listed)

Endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the investigator.
Sign of multi PUB or concomitant other gastro bleeding from esophageal varices, reflux esophagitis, gastritis, Mallory Weiss rifts, ulcus simplex, Dieulafoy's lesion, colon, small bowel, or ulcer distal to the stom in Billroth-resected patients.
Need for treatment during the first 7 days of the study with NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, acetyl salicylic acid (ASA) (including low dose) or clopidogrel.
Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
Chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned during the course of the study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Esomeprazole NaAlso: NexiumGiven as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous	Drug	Esomeprazole
CimetidineGiven as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours	Drug	Cimetidine
Esomeprazole MgAlso: Nexium40 mg tablet once daily for 27 days	Drug	Esomeprazole

Primary outcome

Rate of Clinically Significant Rebleeding Within 72 Hours
Time frame: 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.

8 secondary outcomes

Rate of Clinically Significant Rebleeding During 7 Days
Time frame: 7 days
Rate of Clinically Significant Rebleeding During 30 Days
Time frame: 30 days
Number of Patients With Endoscopic Re-treatment Within 72 Hours
Time frame: 72 hours
Number of Patients With Endoscopic Re-treatment Within 30 Days
Time frame: 30 days
Number of Patients With Surgery Due to Rebleeding Within 72 Hours
Time frame: within 72 hours
Number of Patients With Surgery Due to Rebleeding Within 30 Days
Time frame: within 30 days
Number of Blood Units Transfused Within 72 Hours
Time frame: within 72 hours
Number of Blood Units Transfused Within 30 Days
Time frame: within 30 days

Results and safety

Results posted to the registry on 8 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esomeprazole	111	102
Cimetidine	111	98

Primary outcome: Rate of Clinically Significant Rebleeding Within 72 Hours

Time frame: 72 hours. Number. Unit: participants

Measure	Esomeprazole n = 108	Cimetidine n = 107
No rebleeding	107	101
Rebleeding	1	6

Population analysed: Full analysis set (FAS). All randomised patients, who started the randomised iv treatment (bolus dose), were included in the FAS.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs will be collected from the time of the first administration of IP until the end of study, up to 35 days. SAEs will be collected from signed inform consent until the end of the study, up to 36 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esomeprazole	5 of 110 (4.5%)	22 of 110 (20%)	Not reported
Cimetidine	5 of 105 (4.8%)	20 of 105 (19%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26581750Bai Y, Chen DF, Wang RQ, Chen YX, Shi RH, Tian DA, Chen H, Eklund S, Li ZS; Chinese Peptic Ulcer Bleeding Research Group. Intravenous Esomeprazole for Prevention of Peptic Ulcer Rebleeding: A Randomized Trial in Chinese Patients. Adv Ther. 2015 Nov;32(11):1160-76. doi: 10.1007/s12325-015-0265-6. Epub 2015 Nov 18.
China\_PUB\_Study\_D961DC00007\_Clinical\_Study\_Protocol\_GEL\_Redacted\_(approved)Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tore Lind, MD study director

AstraZeneca Molndal, Sweden

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Esomeprazole Na, Cimetidine and Esomeprazole Mg in people with Bleeding Peptic Ulcer, run by AstraZeneca at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Clinically Significant Rebleeding Within 72 Hours (time frame: 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01757275, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.