Gastrointestinal HemorrhagePhase 2NCT00164788
A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole
A Phase 2 study testing Intravenous bolus injection of esomeprazole and Oral esomeprazole in people with Gastrointestinal Hemorrhage, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by 8mg/h would render gastric pH near neutral and that pH control with esomeprazole given in such a high dose either intravenous or orally is identical. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastrointestinal Hemorrhage
- What is being tested?
- Intravenous bolus injection of esomeprazole and Oral esomeprazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- Jul 2004to Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted with diagnosis of upper gastrointestinal bleeding aged between 18 and 80
- Endoscopic confirmation of a bleeding duodenal or gastric ulcer to which endoscopic control has been obtained
- Absence of H. pylori infection
- Informed written consent
Who cannot join
- Known incompatibility to the study drugs;
- Known incompatibility and hypersensitivity to proton pump inhibitor
- H. pylori infection
- Recent H2RA or PPI use (within last 4 weeks)
- Concomitant use of medications that may interfere gastric acid secretion or motility (e.g. anticholinergic, metoclopramide, domperidone)
- Pregnancy or lactation;
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- Non-compliance e.g. mental subordination
- Nasopharyngeal or oropharyngeal pathology that would prevent passage of a nasal catheter
- Significant liver disease as PPI is metabolized by the cytochrome P-450 system
- Previous gastric surgery
- Chronic Aspirin user
- Presence of esophageal/ gastric varices
- Moribund patients, terminal malignancy \& patients with severe renal disease
- Patient unable to give written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Comparison of High Dose Oral to Intravenous Esomeprazole in Patients After Endoscopic Control to Their Bleeding Peptic Ulcers: an Intra-gastric pH Study.
The investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by 8mg/h would render gastric pH near neutral and that pH control with esomeprazole given in such a high dose either intravenous or orally is identical.
Read the detailed description
Bleeding peptic ulcer is a common and life threatening condition. Endoscopic therapy has become the mainstay of controlling bleeding. Recurrent bleeding after endoscopic control occurs in about 20% of patients with a high associated mortality. We previously demonstrated that the adjunct use of high dose proton pump inhibitor reduces risk of recurrent bleeding and thereby improves patients' outcome [Lau JY N Engl J Med 2000]. The newer PPI, esomeprazole, is an S-isomer of omeprazole. Esomeprazole is more effective in gastric acid control as measured by both basal and pentagastrin acid output when compared to omeprazole. Esomeprazole when given orally at a lower dose achieves a similar gastric control than intravenous esomeprazole. The gastric pH with a high dose esomeprazole when given either orally or intravenously has not been measured among Hong Kong Chinese. If a high dose oral esomeprazole achieves a similar pH control near gastric neutrality, the oral regime can be used in place of the intravenous formulation. This represents significant convenience in dosing and cost savings.
- Conditions
- Gastrointestinal Hemorrhage
- Being tested
- Intravenous bolus injection of esomeprazole, Oral esomeprazole
- Keywords
- 24 hours pH monitoring
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous bolus injection of esomeprazoleDrug
Also called IV Nexium
80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours
Oral esomeprazoleDrug
Also called Oral Nexium
40mg every 12 hours for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| IV Nexium | Active comparator | Intravenous bolus injection of esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours Receives: Drug: Intravenous bolus injection of esomeprazole |
| Oral Nexium | Active comparator | Oral esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 40mg every 12 hours for 24 hours Receives: Drug: Oral esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary measure of this study is the median gastric pH over 24-hour monitoring.
Measured: 24 hours
Secondary outcomes (1)
acid suppressing activity, notably the rate of onset of action, between the two treatment regimens: 1. Percentage time of pH<6 2. Time to reach pH 6 3. Median gastric pH in the first 6 and 12 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: No suitable patients and many patients refused the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Yun-wong Lau, Chinese University of Hong Kong
- Investigators
- James YW Lau, MD, Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164788
- Sponsor's protocol ID
- Ne_pH
- Status last verified
- Aug 2012
- First submitted
- 9 Sep 2005
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of High Dose Oral to Intravenous Esomeprazole in Patients After Endoscopic Control to Their Bleeding Peptic Ulcers: an Intra-gastric pH Study.
- ClinicalTrials.gov ID
- NCT00164788
- Acronym / sponsor ID
- Ne_pH
- Conditions
- Gastrointestinal Hemorrhage
- Keywords
- 24 hours pH monitoring
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No suitable patients and many patients refused the study
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by 8mg/h would render gastric pH near neutral and that pH control with esomeprazole given in such a high dose either intravenous or orally is identical.
Detailed description
Bleeding peptic ulcer is a common and life threatening condition. Endoscopic therapy has become the mainstay of controlling bleeding. Recurrent bleeding after endoscopic control occurs in about 20% of patients with a high associated mortality. We previously demonstrated that the adjunct use of high dose proton pump inhibitor reduces risk of recurrent bleeding and thereby improves patients' outcome [Lau JY N Engl J Med 2000]. The newer PPI, esomeprazole, is an S-isomer of omeprazole. Esomeprazole is more effective in gastric acid control as measured by both basal and pentagastrin acid output when compared to omeprazole. Esomeprazole when given orally at a lower dose achieves a similar gastric control than intravenous esomeprazole. The gastric pH with a high dose esomeprazole when given either orally or intravenously has not been measured among Hong Kong Chinese. If a high dose oral esomeprazole achieves a similar pH control near gastric neutrality, the oral regime can be used in place of the intravenous formulation. This represents significant convenience in dosing and cost savings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Nexium | Active comparator | Drug: Intravenous bolus injection of esomeprazoleIntravenous bolus injection of esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours |
| Oral Nexium | Active comparator | Drug: Oral esomeprazoleOral esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 40mg every 12 hours for 24 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted with diagnosis of upper gastrointestinal bleeding aged between 18 and 80
- Endoscopic confirmation of a bleeding duodenal or gastric ulcer to which endoscopic control has been obtained
- Absence of H. pylori infection
- Informed written consent
Key exclusion criteria (14 listed)
- Known incompatibility to the study drugs;
- Known incompatibility and hypersensitivity to proton pump inhibitor
- H. pylori infection
- Recent H2RA or PPI use (within last 4 weeks)
- Concomitant use of medications that may interfere gastric acid secretion or motility (e.g. anticholinergic, metoclopramide, domperidone)
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 |
|---|---|---|
| Intravenous bolus injection of esomeprazoleAlso: IV Nexium80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours | Drug | IV Nexium |
| Oral esomeprazoleAlso: Oral Nexium40mg every 12 hours for 24 hours | Drug | Oral Nexium |
Primary outcome
The primary measure of this study is the median gastric pH over 24-hour monitoring.
Time frame: 24 hours
1 secondary outcome
acid suppressing activity, notably the rate of onset of action, between the two treatment regimens: 1. Percentage time of pH<6 2. Time to reach pH 6 3. Median gastric pH in the first 6 and 12 hours
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: No suitable patients and many patients refused the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
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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.
James YW Lau, MD principal investigator
Prince of Wales Hospital, Shatin, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous bolus injection of esomeprazole and Oral esomeprazole in people with Gastrointestinal Hemorrhage, run by Chinese University of Hong Kong at 1 site 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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No suitable patients and many patients refused the study). Results are not available in the source record.
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 primary measure of this study is the median gastric pH over 24-hour monitoring. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2012.