Stress Ulcer ProphylaxisPhase 3SUPNCT02157376

Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

A Phase 3 study testing Esomeprazole and Cimetidine in people with Stress Ulcer Prophylaxis, run by AstraZeneca at 15 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

The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Stress Ulcer Prophylaxis
What is being tested?: Esomeprazole and Cimetidine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 343 participants
Where: 15 sitesChina
Study dates: Jul 2014to Feb 2016
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

Critically ill patients
Requirement for mechanical ventilation
At least one major risk factor for stress ulcer related bleeding

Who cannot join

History of gastric or oesophageal surgery
Evidence of active GI bleeding
Advanced renal disease
Treatment with any Proton Pump Inhibitors

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

China15 sites

Research Site
Baotou
Research Site
Changsha
Research Site
Chengdu
Research Site
Chongqing
Research Site
Fuzhou
Research Site
Guangzhou
Research Site
Guilin
Research Site
Haikou
Research Site
Qingdao
Research Site
Shanghai
Research Site
Shenzhen
Research Site
Tianjin
Research Site
Ürümqi
Research Site
Xi'an
Research Site
Zhanjiang

Other trials in China

About this study

Official title: Effect of Intravenous Esomeprazole Versus Cimetidine in Prevention of Stress Ulcer Prophylaxis in Chinese Seriously Ill Patients - a Randomized, Double-blind, Parallel-group Study

Read the detailed description

Stress related upper Gastrointestinal (GI) bleedings are important events associated with morbidity and mortality among seriously ill patients. Data from the literature suggest that stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events and is thus an important therapy in high-risk patients. Esomeprazole has the potential to reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal damage and facilitating coagulation. This study is to reveal whether intravenous (iv) esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is tolerated by Chinese seriously ill patients.

Conditions: Stress Ulcer Prophylaxis
Being tested: Esomeprazole, Cimetidine
Keywords: SUP, Upper GI bleeding, Seriously ill patients
Medical subject headings: Gastrointestinal Hemorrhage

What participants receive

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

EsomeprazoleDrug
Also called Nexium
iv esomeprazole 30 min intermittent infusions given for maximum 14 days
CimetidineDrug
Also called Tagamet
iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days

Study groups in NCT02157376
Study group	Role	What they receive
Esomeprazole active treatment	Experimental	iv esomeprazole 30 min intermittent infusions given for maximum 14 days Receives: Drug: Esomeprazole
Cimetidine active treatment	Active comparator	iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days Receives: Drug: Cimetidine

What is being measured

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

The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase
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.
Measured: 1-14 days

Secondary outcomes (1)

Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase
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.
Measured: 1-14 days

Timeline

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

Jul 2014Feb 2016

First posted6 Jun 2014 (estimated)
Study startJul 2014
Primary completionFeb 2016
Study completionFeb 2016

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 Stress Ulcer ProphylaxisStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 343 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02157376
Sponsor's protocol ID: D961OC00002
Acronym: SUP
Status last verified: Jan 2017
First submitted: 28 May 2014
Last updated: 10 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lou W, Xia Y, Xiang P, Zhang L, Yu X, Lim S, Xu M, Zhao L, Rydholm H, Traxler B, Qin X. Prevention of upper gastrointestinal bleeding in critically ill Chinese patients: a randomized, double-blind study evaluating esomeprazole and cimetidine. Curr Med Res Opin. 2018 Aug;34(8):1449-1455. doi: 10.1080/03007995.2018.1464132. Epub 2018 Apr 20.
PubMed 29638148

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Intravenous Esomeprazole Versus Cimetidine in Prevention of Stress Ulcer Prophylaxis in Chinese Seriously Ill Patients - a Randomized, Double-blind, Parallel-group Study
ClinicalTrials.gov ID: NCT02157376
Acronym / sponsor ID: SUP / D961OC00002
Conditions: Stress Ulcer Prophylaxis
Keywords: SUP, Upper GI bleeding, Seriously ill patients
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 343 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 6 Jun 2014 (estimated)
Results: Posted 23 Jan 2017

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Esomeprazole active treatment	Experimental	Drug: Esomeprazoleiv esomeprazole 30 min intermittent infusions given for maximum 14 days
Cimetidine active treatment	Active comparator	Drug: Cimetidineiv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days

Who may qualify

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

Key inclusion criteria (3 listed)

Critically ill patients
Requirement for mechanical ventilation
At least one major risk factor for stress ulcer related bleeding

Key exclusion criteria (4 listed)

History of gastric or oesophageal surgery
Evidence of active GI bleeding
Advanced renal disease
Treatment with any Proton Pump Inhibitors

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
EsomeprazoleAlso: Nexiumiv esomeprazole 30 min intermittent infusions given for maximum 14 days	Drug	Esomeprazole active treatment
CimetidineAlso: Tagametiv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days	Drug	Cimetidine active treatment

Primary outcome

The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase
Time frame: 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.

1 secondary outcome

Proportion of Patients With Any Overt Upper-GI Bleeding (Significant and Non-significant) During the Treatment Evaluation Phase
Time frame: 1-14 days

Results and safety

Results posted to the registry on 23 Jan 2017, 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	155	133
Cimetidine	156	138

Primary outcome: The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase

Time frame: 1-14 days. Number. Unit: % of participants

Measure	Esomeprazole n = 147	Cimetidine n = 153
Value	2.7	4.6

Esomeprazole vs Cimetidine: Risk Difference (RD): 1.9 (95% CI -2.8 to 6.5), p = 0.393, Pearson's Chi-square

Population analysed: Full analysis set (FAS). All randomized patients in whom at least one dose of randomized treatment has been initiated.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs will be collected from the time of the first administration of IMP until the end of follow-up, up to 15 days. SAEs will be collected from signed inform consent until the end of follow-up, up to 15 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cimetidine	12 of 153 (7.8%)	88 of 153 (57.5%)	Not reported
Esomeprazole	14 of 147 (9.5%)	85 of 147 (57.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29638148Lou W, Xia Y, Xiang P, Zhang L, Yu X, Lim S, Xu M, Zhao L, Rydholm H, Traxler B, Qin X. Prevention of upper gastrointestinal bleeding in critically ill Chinese patients: a randomized, double-blind study evaluating esomeprazole and cimetidine. Curr Med Res Opin. 2018 Aug;34(8):1449-1455. doi: 10.1080/03007995.2018.1464132. Epub 2018 Apr 20.

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.

Xinyu Qin principal investigator

Professor and Chairman, Department of General Surgery,Zhongshan,Hospital, Fudan University

15 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 and Cimetidine in people with Stress Ulcer Prophylaxis, run by AstraZeneca at 15 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 3 inclusion and 4 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 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 23 Jan 2017). 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?

The Percent of Patients With Clinically Significant Upper-GI Bleeding During the Treatment Evaluation Phase (time frame: 1-14 days). 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 NCT02157376, 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 10 Mar 2017.