Peptic Ulcer HemorrhagePhase 4Eso_1y_R6PUBNCT02456012
Long-term Oral Esomeprazole for Prevention of Peptic Ulcer Rebleeding in High-risk Patients
A Phase 4 study testing oral esomeprazole 20 mg twice daily and oral esomeprazole 20 mg once daily in people with Peptic Ulcer Hemorrhage, run by Hsiu-Chi Cheng at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine whether a long-term prophylactic use of esomeprazole 20 mg twice daily or once daily has prevention effectiveness in reducing the recurrence of peptic ulcer bleeding after ulcer healed with 16-week oral esomeprazole therapy in high-risk patients whose Rockall score ≥ 6. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Peptic Ulcer Hemorrhage
- What is being tested?
- oral esomeprazole 20 mg twice daily and oral esomeprazole 20 mg once daily
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2015to 31 Dec 2020
- 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 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants included patients ≥20 years who had undergone gastroscopy for melena, haematochezia, or haematemesis due to bleeding peptic ulcers with major stigmata of recent hemorrhage. The major stigmata of recent haemorrhage were classified as Forrest class Ia, Ib, IIa, and IIb. All of the stigmata are given one or a combination of endoscopic therapies, including local injection of diluted epinephrine 1:10000, bipolar heated probe, argon plasma coagulation, band ligation, or hemoclip therapy. Patients will undergo a follow-up endoscopy about 12 to 16 weeks later to confirm that the ulcer has healed to be less than 0.5 cm; otherwise, patients are not enrolled.
Who cannot join
- Patients are excluded if they had tumor bleeding or ulcer bleeding due to the presence of a Dieulafoy lesion or mechanical factors (e.g, gastrostomy tube induction), comorbid with reflux esophagitis grade C or D, Barrett's esophagus, or marginal ulcer bleeding, hypersensitivity to esomeprazole or any component of the formulation, or had previously participated in the study. Because of concern for patient safety with certain drug-drug interactions, patients who receive anti-platelet therapy, e.g., aspirin, clopidogrel, or others for prophylaxis of established cardiovascular or cerebrovascular diseases will be excluded.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Helicobacter pylori study group, National Cheng Kung University Hospital
Tainan, 70403
About this study
Official title: Secondary Prevention With Long-term Oral Esomeprazole for Peptic Ulcer Recurrence and Rebleeding in High-risk Rockall Scores ≥ 6 Patients
The purpose of this study is to determine whether a long-term prophylactic use of esomeprazole 20 mg twice daily or once daily has prevention effectiveness in reducing the recurrence of peptic ulcer bleeding after ulcer healed with 16-week oral esomeprazole therapy in high-risk patients whose Rockall score ≥ 6.
Read the detailed description
This study is conducted at the inpatient wards of National Cheng Kung University Hospital, a tertiary health care center in Tainan, and Kaohsiung Medical University Hospital in Kaohsiung City, Taiwan. All participants give written informed consent before enrollment. Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after achieving haemostasis by gastroscopy. Patients then receive a 3-day continuous high-dose (8 mg/h) esomeprazole infusion and then receive 40 mg oral esomeprazole twice daily for 11 days and once daily for following 98 days. The total duration of intravenous and oral esomeprazole is 16 weeks. After gastroscopy to confirm enrollment eligibility and ulcer healed, all patients are assessed using the Rockall risk scoring system at the primary endoscopy. Patients with Rockall scores ≥ 6 are randomized into the double-dose (D) group or the single-dose (S) group following simple randomization procedures with a 1:1 allocation ratio according to the result by the investigator who draw an envelope from a large box of sealed envelopes each containing a written code designating the D group or the S group. Patients in the D group and S groups receive 20 mg oral esomeprazole twice daily or once daily for 36 weeks, respectively. The cohort control group includes patients from a previous study who had peptic ulcer bleeding and Rockall scores ≥ 6 but who did not receive esomeprazole or other proton pump inhibitors after 16-week proton pump inhibitor treatment.
One investigator generates the random allocation sequence and enrolls the participants and a different investigator assigns participants to interventions. The endoscopists and staff who check hemoglobin levels, hemodynamic status, melena, hematochezia or the aspirates through a nasogastric tube are blinded to the study group allocation. All enrolled patients are included in the intention-to-treat (ITT) analysis, but patients who are lost to follow-up, discontinued intervention because of adverse events, have a protocol violation or die are excluded from the per-protocol (PP) analysis of the primary endpoint.
The range of co-morbidities evaluated by the Rockall scores include disseminated malignant diseases, liver disease (liver cirrhosis, Child-Pugh A, B, or C), renal disease (end-stage renal disease, chronic kidney disease or acute kidney injury with estimated glomerular filtration rates <30 ml/min [a score of 3 for co-morbidity], or between 30 ml/min and 60 ml/min [a score of 2 for co-morbidity]), heart disease (congestive heart failure, New York Heart Association Function I to IV or coronary artery disease). Other serious co-morbidities include lung disease (chronic obstructive pulmonary disease, pulmonary tuberculosis, pneumonia or empyema), rheumatoid arthritis, sepsis, new onset cerebrovascular accident or recent history of any major surgery (on the thorax, abdomen, central nervous system, long bones or spinal bones) requiring general anesthesia within 14 days before bleeding.
The estimated rebleeding rate within 12 months in the cohort control group is about 15% based on the previous study. The investigators want to be able to detect a difference between the cohort control group and the D group, in which the rebleeding rate is proposed to be 2%, equal to patients with H. pylori ulcers after eradication. The ratio of the patient number in each experiment group (the D group and the S group) to the patient number in the control group is 2:5. With a two-side α value of 0.05 and power of 80% (β=0.20), the total number of patients required is 54 in each experiment group and 135 in the control to detect a difference between the two groups. Assuming the rate of loss follow-up is 10%, 60 patients in each experimental group are enrolled. The investigators use a nominal 0.05 rate of the p value. Data related to baseline characteristics and end points are evaluated using the Student t test, Pearson's χ2 test or Fisher's exact test and the Mann-Whitney U test. In the survival analysis, the log-rank test is used to compare the Kaplan-Meier curves among the three study groups. All tests are two-tailed and p values of less than 0.05 indicate significant differences.
- Conditions
- Peptic Ulcer Hemorrhage
- Being tested
- oral esomeprazole 20 mg twice daily, oral esomeprazole 20 mg once daily
- Keywords
- peptic ulcer hemorrhage, comorbidity, clinical trial
- 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.
oral esomeprazole 20 mg twice dailyDrug
Also called Nexium®, 20 mg, AstraZeneca AB, Södertälje, Sweden
for 36 weeks
oral esomeprazole 20 mg once dailyDrug
Also called Nexium®, 20 mg, AstraZeneca AB, Södertälje, Sweden
for 36 weeks
| Study group | Role | What they receive |
|---|---|---|
| The D group | Experimental | After 3-day intravenous 8 mg/h and 16-week oral 40 mg/day esomeprazole treatment, patients receive oral esomeprazole 20 mg twice daily for 36 weeks. Receives: Drug: oral esomeprazole 20 mg twice daily |
| The S group | Experimental | After 3-day intravenous 8 mg/h and 16-week oral 40 mg/day esomeprazole treatment, patients receive oral esomeprazole 20 mg once daily for 36 weeks. Receives: Drug: oral esomeprazole 20 mg once daily |
| The C group | No intervention | The cohort control group includes patients from a previous study who had peptic ulcer bleeding and Rockall scores ≥ 6 but who did not receive esomeprazole or other proton pump inhibitors after 3-day intravenous 8 mg/h and 16-week oral 40 mg/day esomeprazole treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrent peptic ulcer bleeding during the 1st year
The recurrent bleeding is defined as 1) recurrent melena, haematochezia, the presence of bloody aspirates through a nasogastric tube and 2) relapse of haemodynamic instability, including systolic blood pressure <90 mm Hg, heart rate >120 bpm or a drop in haemoglobin concentration of >2 g/dL, or sudden increase in transfusion requirements. For each patient with either suspected or active rebleeding, the hemoglobin level and gastroscopy are performed to confirm any blood or coffee-ground-like materials in the stomach, or the persistence of stigmata indicating recent haemorrhage. The gastroscopy also determines whether the source of rebleeding was a peptic ulcer or some other non-ulcer bleeding source, such as varices.
Measured: 52 weeks
Secondary outcomes (2)
The recurrence of peptic ulcer confirmed by follow-up endoscopy
In each patient, the follow-up endoscopy will be performed during the period between the 17th and 52th weeks and the definition of recurrence of ulcer is the size of ulcer > 0.5 cm.
Measured: between the 17th and 52th weeks
The recurrent peptic ulcer bleeding during the second year-and-thereafter
After the 52-week therapy, the patients in Group D and S used oral PPIs or not at the discretion of their physicians according to clinical needs. Thus, these patients are divided into the PPIs on-demand group and the PPIs discontinued group. The definition of recurrent bleeding is as the primary outcome.
Measured: Since the 2nd year to the study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startApr 2015
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hsiu-Chi Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hsiu-Chi Cheng, National Cheng-Kung University Hospital
- Investigators
- Bor-Shyang Sheu, MD, Study director, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456012
- Sponsor's protocol ID
- A-BR-104-007
- Other IDs
- R6IIT
- Acronym
- Eso_1y_R6PUB
- Status last verified
- Feb 2022
- First submitted
- 25 May 2015
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan HL, Wu JC, Chan FK, Choi CL, Ching JY, Lee YT, Leung WK, Lau JY, Chung SC, Sung JJ. Is non-Helicobacter pylori, non-NSAID peptic ulcer a common cause of upper GI bleeding? A prospective study of 977 patients. Gastrointest Endosc. 2001 Apr;53(4):438-42. doi: 10.1067/mge.2001.112840.
PubMed 11275883Hung LC, Ching JY, Sung JJ, To KF, Hui AJ, Wong VW, Leong RW, Chan HL, Wu JC, Leung WK, Lee YT, Chung SC, Chan FK. Long-term outcome of Helicobacter pylori-negative idiopathic bleeding ulcers: a prospective cohort study. Gastroenterology. 2005 Jun;128(7):1845-50. doi: 10.1053/j.gastro.2005.03.026.
PubMed 15940620Chow DK, Sung JJ. Non-NSAID non-H. pylori ulcer disease. Best Pract Res Clin Gastroenterol. 2009;23(1):3-9. doi: 10.1016/j.bpg.2008.11.010.
PubMed 19258182Wong GL, Wong VW, Chan Y, Ching JY, Au K, Hui AJ, Lai LH, Chow DK, Siu DK, Lui YN, Wu JC, To KF, Hung LC, Chan HL, Sung JJ, Chan FK. High incidence of mortality and recurrent bleeding in patients with Helicobacter pylori-negative idiopathic bleeding ulcers. Gastroenterology. 2009 Aug;137(2):525-31. doi: 10.1053/j.gastro.2009.05.006. Epub 2009 May 13.
PubMed 19445937Rockall TA, Logan RF, Devlin HB, Northfield TC. Risk assessment after acute upper gastrointestinal haemorrhage. Gut. 1996 Mar;38(3):316-21. doi: 10.1136/gut.38.3.316.
PubMed 8675081Cheng HC, Wu CT, Chang WL, Cheng WC, Chen WY, Sheu BS. Double oral esomeprazole after a 3-day intravenous esomeprazole infusion reduces recurrent peptic ulcer bleeding in high-risk patients: a randomised controlled study. Gut. 2014 Dec;63(12):1864-72. doi: 10.1136/gutjnl-2013-306531. Epub 2014 Mar 21.
PubMed 24658598Marmo R, Koch M, Cipolletta L, Capurso L, Grossi E, Cestari R, Bianco MA, Pandolfo N, Dezi A, Casetti T, Lorenzini I, Germani U, Imperiali G, Stroppa I, Barberani F, Boschetto S, Gigliozzi A, Gatto G, Peri V, Buzzi A, Della Casa D, Di Cicco M, Proietti M, Aragona G, Giangregorio F, Allegretta L, Tronci S, Michetti P, Romagnoli P, Piubello W, Ferri B, Fornari F, Del Piano M, Pagliarulo M, Di Mitri R, Trallori G, Bagnoli S, Frosini G, Macchiarelli R, Sorrentini I, Pietrini L, De Stefano S, Ceglia T, Chiozzini G, Salvagnini M, Di Muzio D, Rotondano G; Italian registry on upper gastrointestinal bleeding (Progetto Nazionale Emorragie Digestive--PNED 2). Predicting mortality in non-variceal upper gastrointestinal bleeders: validation of the Italian PNED Score and Prospective Comparison with the Rockall Score. Am J Gastroenterol. 2010 Jun;105(6):1284-91. doi: 10.1038/ajg.2009.687. Epub 2010 Jan 5.
PubMed 20051943Chiang HC, Yang EH, Hu HM, Chen WY, Chang WL, Wu CT, Wu DC, Sheu BS, Cheng HC. An extended 36-week oral esomeprazole improved long-term recurrent peptic ulcer bleeding in patients at high risk of rebleeding. BMC Gastroenterol. 2022 Oct 21;22(1):439. doi: 10.1186/s12876-022-02534-0.
PubMed 36271335
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Prevention With Long-term Oral Esomeprazole for Peptic Ulcer Recurrence and Rebleeding in High-risk Rockall Scores ≥ 6 Patients
- ClinicalTrials.gov ID
- NCT02456012
- Acronym / sponsor ID
- Eso_1y_R6PUB / A-BR-104-007
- Conditions
- Peptic Ulcer Hemorrhage
- Keywords
- peptic ulcer hemorrhage, comorbidity, clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Hsiu-Chi ChengUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 May 2015 (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 purpose of this study is to determine whether a long-term prophylactic use of esomeprazole 20 mg twice daily or once daily has prevention effectiveness in reducing the recurrence of peptic ulcer bleeding after ulcer healed with 16-week oral esomeprazole therapy in high-risk patients whose Rockall score ≥ 6.
Detailed description
This study is conducted at the inpatient wards of National Cheng Kung University Hospital, a tertiary health care center in Tainan, and Kaohsiung Medical University Hospital in Kaohsiung City, Taiwan. All participants give written informed consent before enrollment. Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after achieving haemostasis by gastroscopy. Patients then receive a 3-day continuous high-dose (8 mg/h) esomeprazole infusion and then receive 40 mg oral esomeprazole twice daily for 11 days and once daily for following 98 days. The total duration of intravenous and oral esomeprazole is 16 weeks. After gastroscopy to confirm enrollment eligibility and ulcer healed, all patients are assessed using the Rockall risk scoring system at the primary endoscopy. Patients with Rockall scores ≥ 6 are randomized into the double-dose (D) group or the single-dose (S) group following simple randomization procedures with a 1:1 allocation ratio according to the result by the investigator who draw an envelope from a large box of sealed envelopes each containing a written code designating the D group or the S group. Patients in the D group and S groups receive 20 mg oral esomeprazole twice daily or once daily for 36 weeks, respectively. The cohort control group includes patients from a previous study who had peptic ulcer bleeding and Rockall scores ≥ 6 but who did not receive esomeprazole or other proton pump inhibitors after 16-week proton pump inhibitor treatment.
One investigator generates the random allocation sequence and enrolls the participants and a different investigator assigns participants to interventions. The endoscopists and staff who check hemoglobin levels, hemodynamic status, melena, hematochezia or the aspirates through a nasogastric tube are blinded to the study group allocation. All enrolled patients are included in the intention-to-treat (ITT) analysis, but patients who are lost to follow-up, discontinued intervention because of adverse events, have a protocol violation or die are excluded from the per-protocol (PP) analysis of the primary endpoint.
The range of co-morbidities evaluated by the Rockall scores include disseminated malignant diseases, liver disease (liver cirrhosis, Child-Pugh A, B, or C), renal disease (end-stage renal disease, chronic kidney disease or acute kidney injury with estimated glomerular filtration rates <30 ml/min [a score of 3 for co-morbidity], or between 30 ml/min and 60 ml/min [a score of 2 for co-morbidity]), heart disease (congestive heart failure, New York Heart Association Function I to IV or coronary artery disease). Other serious co-morbidities include lung disease (chronic obstructive pulmonary disease, pulmonary tuberculosis, pneumonia or empyema), rheumatoid arthritis, sepsis, new onset cerebrovascular accident or recent history of any major surgery (on the thorax, abdomen, central nervous system, long bones or spinal bones) requiring general anesthesia within 14 days before bleeding.
The estimated rebleeding rate within 12 months in the cohort control group is about 15% based on the previous study. The investigators want to be able to detect a difference between the cohort control group and the D group, in which the rebleeding rate is proposed to be 2%, equal to patients with H. pylori ulcers after eradication. The ratio of the patient number in each experiment group (the D group and the S group) to the patient number in the control group is 2:5. With a two-side α value of 0.05 and power of 80% (β=0.20), the total number of patients required is 54 in each experiment group and 135 in the control to detect a difference between the two groups. Assuming the rate of loss follow-up is 10%, 60 patients in each experimental group are enrolled. The investigators use a nominal 0.05 rate of the p value. Data related to baseline characteristics and end points are evaluated using the Student t test, Pearson's χ2 test or Fisher's exact test and the Mann-Whitney U test. In the survival analysis, the log-rank test is used to compare the Kaplan-Meier curves among the three study groups. All tests are two-tailed and p values of less than 0.05 indicate significant differences.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The D group | Experimental | Drug: oral esomeprazole 20 mg twice dailyAfter 3-day intravenous 8 mg/h and 16-week oral 40 mg/day esomeprazole treatment, patients receive oral esomeprazole 20 mg twice daily for 36 weeks. |
| The S group | Experimental | Drug: oral esomeprazole 20 mg once dailyAfter 3-day intravenous 8 mg/h and 16-week oral 40 mg/day esomeprazole treatment, patients receive oral esomeprazole 20 mg once daily for 36 weeks. |
| The C group | No intervention | –The cohort control group includes patients from a previous study who had peptic ulcer bleeding and Rockall scores ≥ 6 but who did not receive esomeprazole or other proton pump inhibitors after 3-day intravenous 8 mg/h and 16-week oral 40 mg/day esomeprazole treatment. |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants included patients ≥20 years who had undergone gastroscopy for melena, haematochezia, or haematemesis due to bleeding peptic ulcers with major stigmata of recent hemorrhage. The major stigmata of recent haemorrhage were classified as Forrest class Ia, Ib, IIa, and IIb. All of the stigmata are given one or a combination of endoscopic therapies, including local injection of diluted epinephrine 1:10000, bipolar heated probe, argon plasma coagulation, band ligation, or hemoclip therapy. Patients will undergo a follow-up endoscopy about 12 to 16 weeks later to confirm that the ulcer has healed to be less than 0.5 cm; otherwise, patients are not enrolled.
Key exclusion criteria (1 listed)
- Patients are excluded if they had tumor bleeding or ulcer bleeding due to the presence of a Dieulafoy lesion or mechanical factors (e.g, gastrostomy tube induction), comorbid with reflux esophagitis grade C or D, Barrett's esophagus, or marginal ulcer bleeding, hypersensitivity to esomeprazole or any component of the formulation, or had previously participated in the study. Because of concern for patient safety with certain drug-drug interactions, patients who receive anti-platelet therapy, e.g., aspirin, clopidogrel, or others for prophylaxis of established cardiovascular or cerebrovascular diseases will be excluded.
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 |
|---|---|---|
| oral esomeprazole 20 mg twice dailyAlso: Nexium®, 20 mg, AstraZeneca AB, Södertälje, Swedenfor 36 weeks | Drug | The D group |
| oral esomeprazole 20 mg once dailyAlso: Nexium®, 20 mg, AstraZeneca AB, Södertälje, Swedenfor 36 weeks | Drug | The S group |
Primary outcome
The recurrent peptic ulcer bleeding during the 1st year
Time frame: 52 weeks
The recurrent bleeding is defined as 1) recurrent melena, haematochezia, the presence of bloody aspirates through a nasogastric tube and 2) relapse of haemodynamic instability, including systolic blood pressure <90 mm Hg, heart rate >120 bpm or a drop in haemoglobin concentration of >2 g/dL, or sudden increase in transfusion requirements. For each patient with either suspected or active rebleeding, the hemoglobin level and gastroscopy are performed to confirm any blood or coffee-ground-like materials in the stomach, or the persistence of stigmata indicating recent haemorrhage. The gastroscopy also determines whether the source of rebleeding was a peptic ulcer or some other non-ulcer bleeding source, such as varices.
2 secondary outcomes
The recurrence of peptic ulcer confirmed by follow-up endoscopy
Time frame: between the 17th and 52th weeks
The recurrent peptic ulcer bleeding during the second year-and-thereafter
Time frame: Since the 2nd year to the study end
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 22 Feb 2022.
- Background: PubMed 11275883Chan HL, Wu JC, Chan FK, Choi CL, Ching JY, Lee YT, Leung WK, Lau JY, Chung SC, Sung JJ. Is non-Helicobacter pylori, non-NSAID peptic ulcer a common cause of upper GI bleeding? A prospective study of 977 patients. Gastrointest Endosc. 2001 Apr;53(4):438-42. doi: 10.1067/mge.2001.112840.
- Background: PubMed 15940620Hung LC, Ching JY, Sung JJ, To KF, Hui AJ, Wong VW, Leong RW, Chan HL, Wu JC, Leung WK, Lee YT, Chung SC, Chan FK. Long-term outcome of Helicobacter pylori-negative idiopathic bleeding ulcers: a prospective cohort study. Gastroenterology. 2005 Jun;128(7):1845-50. doi: 10.1053/j.gastro.2005.03.026.
- Background: PubMed 19258182Chow DK, Sung JJ. Non-NSAID non-H. pylori ulcer disease. Best Pract Res Clin Gastroenterol. 2009;23(1):3-9. doi: 10.1016/j.bpg.2008.11.010.
- Background: PubMed 19445937Wong GL, Wong VW, Chan Y, Ching JY, Au K, Hui AJ, Lai LH, Chow DK, Siu DK, Lui YN, Wu JC, To KF, Hung LC, Chan HL, Sung JJ, Chan FK. High incidence of mortality and recurrent bleeding in patients with Helicobacter pylori-negative idiopathic bleeding ulcers. Gastroenterology. 2009 Aug;137(2):525-31. doi: 10.1053/j.gastro.2009.05.006. Epub 2009 May 13.
- Background: PubMed 8675081Rockall TA, Logan RF, Devlin HB, Northfield TC. Risk assessment after acute upper gastrointestinal haemorrhage. Gut. 1996 Mar;38(3):316-21. doi: 10.1136/gut.38.3.316.
- Background: PubMed 24658598Cheng HC, Wu CT, Chang WL, Cheng WC, Chen WY, Sheu BS. Double oral esomeprazole after a 3-day intravenous esomeprazole infusion reduces recurrent peptic ulcer bleeding in high-risk patients: a randomised controlled study. Gut. 2014 Dec;63(12):1864-72. doi: 10.1136/gutjnl-2013-306531. Epub 2014 Mar 21.
- Background: PubMed 20051943Marmo R, Koch M, Cipolletta L, Capurso L, Grossi E, Cestari R, Bianco MA, Pandolfo N, Dezi A, Casetti T, Lorenzini I, Germani U, Imperiali G, Stroppa I, Barberani F, Boschetto S, Gigliozzi A, Gatto G, Peri V, Buzzi A, Della Casa D, Di Cicco M, Proietti M, Aragona G, Giangregorio F, Allegretta L, Tronci S, Michetti P, Romagnoli P, Piubello W, Ferri B, Fornari F, Del Piano M, Pagliarulo M, Di Mitri R, Trallori G, Bagnoli S, Frosini G, Macchiarelli R, Sorrentini I, Pietrini L, De Stefano S, Ceglia T, Chiozzini G, Salvagnini M, Di Muzio D, Rotondano G; Italian registry on upper gastrointestinal bleeding (Progetto Nazionale Emorragie Digestive--PNED 2). Predicting mortality in non-variceal upper gastrointestinal bleeders: validation of the Italian PNED Score and Prospective Comparison with the Rockall Score. Am J Gastroenterol. 2010 Jun;105(6):1284-91. doi: 10.1038/ajg.2009.687. Epub 2010 Jan 5.
- Derived from this study: PubMed 36271335Chiang HC, Yang EH, Hu HM, Chen WY, Chang WL, Wu CT, Wu DC, Sheu BS, Cheng HC. An extended 36-week oral esomeprazole improved long-term recurrent peptic ulcer bleeding in patients at high risk of rebleeding. BMC Gastroenterol. 2022 Oct 21;22(1):439. doi: 10.1186/s12876-022-02534-0.
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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.
Bor-Shyang Sheu, MD study director
National Cheng-Kung University 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 oral esomeprazole 20 mg twice daily and oral esomeprazole 20 mg once daily in people with Peptic Ulcer Hemorrhage, run by Hsiu-Chi Cheng 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 1 inclusion and 1 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 22 Feb 2022. 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.
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?
The recurrent peptic ulcer bleeding during the 1st year (time frame: 52 weeks). 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 NCT02456012, which also lists 8 linked publications.
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 22 Feb 2022.