GastritisPhase 4NCT04678492
Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
A Phase 4 study testing Esomeprazole, Amoxicillin and Bismuth in people with Gastritis and Dyspepsia, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth，esomeprazole，tetracycline and furazolidone) in H. pylori rescue therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastritis, Dyspepsia, Helicobacter Pylori Infection
- What is being tested?
- Esomeprazole, Amoxicillin and Bismuth
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2020to 20 Dec 2021
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had failed H.pylori eradication therapies before.
- Age between 18~70, both gender.
- Patients who had failed H.pylori eradication therapies during last 2 years and stop the eradication therapies for at least 3 months.
- Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.
Who cannot join
- Patients are excluded if they have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
- Contraindications to study drugs.
- Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
- Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- Pregnant or lactating women.
- Underwent upper gastrointestinal Surgery.
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- Patients with moderate or severe atypical hyperplasia or high-grade intraepithelial neoplasia.
- have symptom of dysphagia.
- Evidence of bleeding or iron efficiency anemia.
- A history of malignancy.
- Drug or alcohol abuse history in the past 1 year.
- Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
- a person with a mental disorder.
- Enrolled in other clinical trials in the past 3 months.
- Refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth，esomeprazole，tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Read the detailed description
The study will include three phases: screening, treatment and follow-up.
Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test.
- Being tested
- Esomeprazole, Amoxicillin, Bismuth, Tetracycline, Furazolidone
- Keywords
- Helicobacter pylori, High-dose dual therapy, Bismuth-combining quadruple therapy
- Medical subject headings
- Gastritis, Dyspepsia, Stomach Neoplasms, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Also called Nexium
High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet TID plus amoxicillin 500 mg 2 capsules TID
AmoxicillinDrug
Also called Amoxy
High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 40mg 1 tablet TID
BismuthDrug
Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 40 mg 1 tablets BID，tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID
EsomeprazoleDrug
Also called Nexium
Bismuth-containing quadruple therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet BID plus bismuth 110 mg 2 capsules BID，tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID
TetracyclineDrug
Bismuth-containing quadruple therapy:given for 14 days at a dose of tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID，esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID
FurazolidoneDrug
Bismuth-containing quadruple therapy:given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus tetracycline 250mg 2 capsules TID，esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID
| Study group | Role | What they receive |
|---|---|---|
| High-dose esomeprazole and amoxicillin dual therapy | Experimental | Esomeprazole 40 mg and amoxicillin 1000 mg by mouth，three time daily for 14 days Receives: Drug: Esomeprazole; Drug: Amoxicillin |
| Bismuth-containing quadruple therapy | Active comparator | Tetracycline 500mg three time daily for 14 days，furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days. Receives: Drug: Bismuth; Drug: Esomeprazole; Drug: Tetracycline; Drug: Furazolidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication
The primary end point of this study is H.pylori eradication，established by negative [13C] urea breath test （DOB value below 3.9）28 days after the end of eradication
Measured: 28 days after treatment
Secondary outcomes (2)
symptoms effective rates
symptoms improvement rates Evaluation improvement rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom improvement rate =#total score before treatment - total score after treatment#/total score before treatment x100%. Total score = frequency + severity.Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence, etc. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe
Measured: 14 days of treatment, and 28 days after treatment
adverse events
Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain.
Measured: 14 days of treatment, and 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start20 Dec 2020
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
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 GastritisStudies 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)
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678492
- Sponsor's protocol ID
- KY20202114-F-1
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2020
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bi H, Chen X, Chen Y, Zhao X, Wang S, Wang J, Lyu T, Han S, Lin T, Li M, Yuan D, Liu J, Shi Y. Efficacy and safety of high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial. Chin Med J (Engl). 2022 Jul 20;135(14):1707-1715. doi: 10.1097/CM9.0000000000002289.
PubMed 36193978
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy
- ClinicalTrials.gov ID
- NCT04678492
- Acronym / sponsor ID
- KY20202114-F-1
- Keywords
- Helicobacter pylori, High-dose dual therapy, Bismuth-combining quadruple therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 22 Dec 2020 (actual)
- 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.
This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth，esomeprazole，tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.
Detailed description
The study will include three phases: screening, treatment and follow-up.
Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test，rapid urease test or helicobacter pylori stool antigen test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose esomeprazole and amoxicillin dual therapy | Experimental | Drug: Esomeprazole, Drug: AmoxicillinEsomeprazole 40 mg and amoxicillin 1000 mg by mouth，three time daily for 14 days |
| Bismuth-containing quadruple therapy | Active comparator | Drug: Bismuth, Drug: Esomeprazole, Drug: Tetracycline, Drug: FurazolidoneTetracycline 500mg three time daily for 14 days，furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who had failed H.pylori eradication therapies before.
- Age between 18~70, both gender.
- Patients who had failed H.pylori eradication therapies during last 2 years and stop the eradication therapies for at least 3 months.
- Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.
Key exclusion criteria (15 listed)
- Patients are excluded if they have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
- Contraindications to study drugs.
- Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
- Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- Pregnant or lactating women.
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: NexiumHigh-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet TID plus amoxicillin 500 mg 2 capsules TID | Drug | High-dose esomeprazole and amoxicillin dual therapy |
| AmoxicillinAlso: AmoxyHigh-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 40mg 1 tablet TID | Drug | High-dose esomeprazole and amoxicillin dual therapy |
| BismuthBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 40 mg 1 tablets BID，tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID | Drug | Bismuth-containing quadruple therapy |
| EsomeprazoleAlso: NexiumBismuth-containing quadruple therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet BID plus bismuth 110 mg 2 capsules BID，tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID | Drug | Bismuth-containing quadruple therapy |
| TetracyclineBismuth-containing quadruple therapy:given for 14 days at a dose of tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID，esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID | Drug | Bismuth-containing quadruple therapy |
| FurazolidoneBismuth-containing quadruple therapy:given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus tetracycline 250mg 2 capsules TID，esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID | Drug | Bismuth-containing quadruple therapy |
Primary outcome
Helicobacter pylori eradication
Time frame: 28 days after treatment
The primary end point of this study is H.pylori eradication，established by negative [13C] urea breath test （DOB value below 3.9）28 days after the end of eradication
2 secondary outcomes
symptoms effective rates
Time frame: 14 days of treatment, and 28 days after treatment
adverse events
Time frame: 14 days of treatment, and 28 days after treatment
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 31 Jan 2023.
- Derived from this study: PubMed 36193978Bi H, Chen X, Chen Y, Zhao X, Wang S, Wang J, Lyu T, Han S, Lin T, Li M, Yuan D, Liu J, Shi Y. Efficacy and safety of high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial. Chin Med J (Engl). 2022 Jul 20;135(14):1707-1715. doi: 10.1097/CM9.0000000000002289.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Esomeprazole, Amoxicillin and Bismuth in people with Gastritis and Dyspepsia, run by Xijing Hospital of Digestive Diseases 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 15 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 31 Jan 2023. 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?
Helicobacter pylori eradication (time frame: 28 days after treatment). 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 NCT04678492, 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 31 Jan 2023.