EndoscopyNCT00709046
High Dose Versus Standard Dose Proton Pump Inhibitor (PPI) in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Treatment
A study testing High dose pantoprazole infusion and Standard dose pantoprazole infusion in people with Endoscopy and Peptic Ulcer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The study was designed to evaluate the efficacy an adjuvant use of standard dose or high dose of proton pump inhibitor after combined endoscopic hemostasis therapy. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Endoscopy, Peptic Ulcer, Bleeding
- What is being tested?
- High dose pantoprazole infusion and Standard dose pantoprazole infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Jan 2010
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adults aged above 16 years old with acute nonvariceal upper gastrointestinal bleeding
- read, agree to attend the study, and signed informed consent indicated to receive esophagogastroduodenoscopy(EGD)
- peptic ulcers with high risk lesions (active bleeding: spurting, oozing peptic ulcers. Ulcers with NBVV: nonbleeding visible vessel)
Who cannot join
- unable to receive EGD (unable to open mouth, upper gastrointestinal obstruction)
- bleeding tendency (platelet < 50x109/L, prothrombin time INR >2, ongoing use of heparin or coumadin)
- gastric malignancy
- myocardial infarction within recent one week
- recent cerebrovascular event within recent one week
- pregnancy
- refuse to attend the study
- known allergy history to epinephrine or pantoprazole
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chieh-Chang Chen, MD, 886-5-532-3911 ext. 2200, chiehchang.chen@gmail.com
About this study
Official title: High Dose Versus Standard Dose Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Hemostasis: A Prospective Randomized Comparative Study
The study was designed to evaluate the efficacy an adjuvant use of standard dose or high dose of proton pump inhibitor after combined endoscopic hemostasis therapy.
Read the detailed description
Acute peptic ulcer bleeding remains the most common cause of acute upper gastrointestinal bleeding. Endoscopy serves as a tool for initial diagnosis and triage and also a tool for immediate hemostasis, especially for high-risk lesions. High-risk lesions include peptic ulcers with active spurting vessel, oozing vessel, or NBVV, nonbleeding visible vessel. Current modalities of endoscopic hemostasis include epinephrine injection, endoscopic coaptive thermocoagulation, hemoclipping. Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, decreasing hospitalization days. Current evidence also shows that combination therapy with epinephrine injection and heater probe thermocoagulation/hemo-clip hemostasis is more effective than epinephrine injection alone or than heater probe thermocoagulation alone, or than hemoclip hemostasis alone. Studies showed a high dose intravenous proton pump inhibitor infusion after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, it was still controversial whether an adjuvant use of standard-dose proton pump inhibitor therapy to endoscopic therapy had similar benefit. We hypothesized that an adjuvant use of standard dose of proton pump inhibitor after combined endoscopic hemostasis therapy offer similar benefit as high dose proton pump inhibitor did.
- Conditions
- Endoscopy, Peptic Ulcer, Bleeding, Proton Pump Inhibitors
- Being tested
- High dose pantoprazole infusion, Standard dose pantoprazole infusion
- Keywords
- Endoscopic treatment, Peptic ulcer, Bleeding, Thermocoagulation, Proton pump inhibitors
- 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.
High dose pantoprazole infusionDrug
Also called Pantoloc
Pantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs
Standard dose pantoprazole infusionDrug
Also called Pantoloc
Pantoprazole 40mg iv bolus qd x 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | High dose pantoprazole infusion Receives: Drug: High dose pantoprazole infusion |
| 2 | Active comparator | standard dose pantoprazole infusion Receives: Drug: Standard dose pantoprazole infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of initial hemostasis and the rate of recurrent bleeding
Measured: 72hr
Secondary outcomes (1)
need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality
Measured: 30day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709046
- Sponsor's protocol ID
- 200710033M
- Status last verified
- Jan 2010
- First submitted
- 30 Jun 2008
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen CC, Lee JY, Fang YJ, Hsu SJ, Han ML, Tseng PH, Liou JM, Hu FC, Lin TL, Wu MS, Wang HP, Lin JT. Randomised clinical trial: high-dose vs. standard-dose proton pump inhibitors for the prevention of recurrent haemorrhage after combined endoscopic haemostasis of bleeding peptic ulcers. Aliment Pharmacol Ther. 2012 Apr;35(8):894-903. doi: 10.1111/j.1365-2036.2012.05047.x. Epub 2012 Feb 28.
PubMed 22369682
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Versus Standard Dose Proton Pump Inhibitor in High-risk Bleeding Peptic Ulcers After Combined Endoscopic Hemostasis: A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT00709046
- Acronym / sponsor ID
- 200710033M
- Conditions
- Endoscopy, Peptic Ulcer, Bleeding, Proton Pump Inhibitors
- Keywords
- Endoscopic treatment, Peptic ulcer, Bleeding, Thermocoagulation, Proton pump inhibitors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (estimated)
- First posted
- 3 Jul 2008 (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 study was designed to evaluate the efficacy an adjuvant use of standard dose or high dose of proton pump inhibitor after combined endoscopic hemostasis therapy.
Detailed description
Acute peptic ulcer bleeding remains the most common cause of acute upper gastrointestinal bleeding. Endoscopy serves as a tool for initial diagnosis and triage and also a tool for immediate hemostasis, especially for high-risk lesions. High-risk lesions include peptic ulcers with active spurting vessel, oozing vessel, or NBVV, nonbleeding visible vessel. Current modalities of endoscopic hemostasis include epinephrine injection, endoscopic coaptive thermocoagulation, hemoclipping. Endoscopic hemostasis has been documented by a number of clinical studies to be effective in decreasing rebleeding, need for emergency surgery, decreasing hospitalization days. Current evidence also shows that combination therapy with epinephrine injection and heater probe thermocoagulation/hemo-clip hemostasis is more effective than epinephrine injection alone or than heater probe thermocoagulation alone, or than hemoclip hemostasis alone. Studies showed a high dose intravenous proton pump inhibitor infusion after initial endoscopic hemostasis reduced recurrent ulcer bleeding. However, it was still controversial whether an adjuvant use of standard-dose proton pump inhibitor therapy to endoscopic therapy had similar benefit. We hypothesized that an adjuvant use of standard dose of proton pump inhibitor after combined endoscopic hemostasis therapy offer similar benefit as high dose proton pump inhibitor did.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: High dose pantoprazole infusionHigh dose pantoprazole infusion |
| 2 | Active comparator | Drug: Standard dose pantoprazole infusionstandard dose pantoprazole infusion |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- adults aged above 16 years old with acute nonvariceal upper gastrointestinal bleeding
- read, agree to attend the study, and signed informed consent indicated to receive esophagogastroduodenoscopy(EGD)
- peptic ulcers with high risk lesions (active bleeding: spurting, oozing peptic ulcers. Ulcers with NBVV: nonbleeding visible vessel)
Key exclusion criteria (8 listed)
- unable to receive EGD (unable to open mouth, upper gastrointestinal obstruction)
- bleeding tendency (platelet < 50x109/L, prothrombin time INR >2, ongoing use of heparin or coumadin)
- gastric malignancy
- myocardial infarction within recent one week
- recent cerebrovascular event within recent one week
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 |
|---|---|---|
| High dose pantoprazole infusionAlso: PantolocPantoprazole 80mg iv bolus, 8mg/hr infusion for 72hrs | Drug | 1 |
| Standard dose pantoprazole infusionAlso: PantolocPantoprazole 40mg iv bolus qd x 3 days | Drug | 2 |
Primary outcome
rate of initial hemostasis and the rate of recurrent bleeding
Time frame: 72hr
1 secondary outcome
need for surgical intervention to control bleeding, transfusion requirements, length of hospital stay (in days), and 30-day mortality
Time frame: 30day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
- Derived from this study: PubMed 22369682Chen CC, Lee JY, Fang YJ, Hsu SJ, Han ML, Tseng PH, Liou JM, Hu FC, Lin TL, Wu MS, Wang HP, Lin JT. Randomised clinical trial: high-dose vs. standard-dose proton pump inhibitors for the prevention of recurrent haemorrhage after combined endoscopic haemostasis of bleeding peptic ulcers. Aliment Pharmacol Ther. 2012 Apr;35(8):894-903. doi: 10.1111/j.1365-2036.2012.05047.x. Epub 2012 Feb 28.
Related trials for Endoscopy
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
RecruitingObservational study
Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study
Colorectal Cancer
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High dose pantoprazole infusion and Standard dose pantoprazole infusion in people with Endoscopy and Peptic Ulcer, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 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: status not confirmed, as of the sponsor's last update on 12 Jan 2010. 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chieh-Chang Chen, MD (886-5-532-3911 ext. 2200, chiehchang.chen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of initial hemostasis and the rate of recurrent bleeding (time frame: 72hr). 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 NCT00709046, 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 12 Jan 2010.