Peptic Ulcer HemorrhagePhase 4NCT00279123
Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers
A Phase 4 study testing pantoprazole infusion, pantoprazole bolus and no treatment in people with Peptic Ulcer Hemorrhage, run by Kwong Wah Hospital at 1 site in China.
Trial summary
Endoscopic treatment of bleeding peptic ulcers is effective to prevent rebleeding. Adjuvant medical treatment to increase gastric pH may further decrease rebleeding. Recent studies on potent acid suppression by proton pump inhibitors (PPI) demonstrated the efficacy in preventing rebleeding. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- pantoprazole infusion, pantoprazole bolus and no treatment
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteChina
- Study dates
- Jan 2002to not given
- Phase
- Phase 4
- 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 0 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- patients presenting with upper gastrointestinal bleeding with upper endoscopy showing a bleeding peptic ulcer with major stigmata of haemorrhage and after successful endoscopic haemostasis.
Who cannot join
- previous gastrectomy and vagotomy
- patient taking warfarin
- intake of anti-secretory drugs in the previous 48 hours
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic treatment of bleeding peptic ulcers is effective to prevent rebleeding. Adjuvant medical treatment to increase gastric pH may further decrease rebleeding. Recent studies on potent acid suppression by proton pump inhibitors (PPI) demonstrated the efficacy in preventing rebleeding. Lau demonstrated that high dose intravenous infusion of omeprazole decreased rebleeding in peptic ulcers with stigmata of recent hemorrhage.
There is little data regarding the effect of pantoprazole on bleeding peptic ulcers. Furthermore, the optimal dose of PPI is unknown. Few studies have included measurement of gastric pH in addition to clinical outcome.
This study compares the effect of two doses of intravenous pantoprazole with no acid suppression in bleeding peptic ulcers after endoscopic therapy. In addition to the usual clinical endpoints, gastric pH is monitored to study the relation of pH elevation and the clinical outcome.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- pantoprazole infusion, pantoprazole bolus, no treatment
- 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.
pantoprazole infusionDrug
pantoprazole bolusDrug
no treatmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rebleeding rate within 30 days after endoscopic therapy
Secondary outcomes (6)
Transfusion requirement
duration of hospital stay
need for operative intervention
mortality rate
gastric pH
side effects of pantoprazole
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer HemorrhageStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Kwong Wah Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wai-ka Hung, MBBS, Principal investigator, Department of Surgery, Kowng Wah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279123
- Sponsor's protocol ID
- PPI Trial
- Status last verified
- Jan 2006
- First submitted
- 17 Jan 2006
- Last updated
- 19 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers
- ClinicalTrials.gov ID
- NCT00279123
- Acronym / sponsor ID
- PPI Trial
- Conditions
- Peptic Ulcer Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Kwong Wah HospitalUniversity, hospital or other
- Study start
- Jan 2002
- First posted
- 19 Jan 2006 (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.
Endoscopic treatment of bleeding peptic ulcers is effective to prevent rebleeding. Adjuvant medical treatment to increase gastric pH may further decrease rebleeding. Recent studies on potent acid suppression by proton pump inhibitors (PPI) demonstrated the efficacy in preventing rebleeding. Lau demonstrated that high dose intravenous infusion of omeprazole decreased rebleeding in peptic ulcers with stigmata of recent hemorrhage.
There is little data regarding the effect of pantoprazole on bleeding peptic ulcers. Furthermore, the optimal dose of PPI is unknown. Few studies have included measurement of gastric pH in addition to clinical outcome.
This study compares the effect of two doses of intravenous pantoprazole with no acid suppression in bleeding peptic ulcers after endoscopic therapy. In addition to the usual clinical endpoints, gastric pH is monitored to study the relation of pH elevation and the clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients presenting with upper gastrointestinal bleeding with upper endoscopy showing a bleeding peptic ulcer with major stigmata of haemorrhage and after successful endoscopic haemostasis.
Key exclusion criteria (3 listed)
- previous gastrectomy and vagotomy
- patient taking warfarin
- intake of anti-secretory drugs in the previous 48 hours
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 |
|---|---|---|
| pantoprazole infusion | Drug | – |
| pantoprazole bolus | Drug | – |
| no treatment | Drug | – |
Primary outcome
Rebleeding rate within 30 days after endoscopic therapy
6 secondary outcomes
Transfusion requirement
duration of hospital stay
need for operative intervention
mortality rate
gastric pH
side effects of pantoprazole
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2006.
Related trials for Peptic Ulcer Hemorrhage
RecruitingPhase 4
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
Coronary Artery Disease, Percutaneous Coronary Intervention
RecruitingPhase 2
Tegoprazan Versus Lansoprazole for Endoscopic Ulcer Healing in Bleeding Peptic Ulcers
Peptic Ulcer Bleeding
Not yet recruiting
Potassium-competitive Acid Blocker Versus Double Dose Proton Pump Inhibitors in High High-risk Peptic Ulcer Bleeding
Bleeding
Recruiting
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
Roux-en-y Anastomosis Site, Marginal Ulcer
Recruiting
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding
Acute Gastrointestinal Bleeding
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.
Wai-ka Hung, MBBS principal investigator
Department of Surgery, Kowng Wah Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pantoprazole infusion, pantoprazole bolus and no treatment in people with Peptic Ulcer Hemorrhage, run by Kwong Wah Hospital 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 1 inclusion and 3 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 19 Jan 2006. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rebleeding rate within 30 days after endoscopic therapy. 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 19 Jan 2006.