Gastric CancerPhase 4NCT04209933

Helicobacter Pylori Eradication With Different Bismuth Quadruple Therapies

A Phase 4 study testing Bismuth potassium citrate containing quadruple therapy, Colloidal pectin bismuth capsules containing quadruple therapy and Colloidal pectin bismuth particles A quadruple therapy in people with Gastric Cancer and Helicobacter Pylori Infection, run by Xijing Hospital of Digestive Diseases at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastric Cancer, Helicobacter Pylori Infection, Bismuth
What is being tested?: Bismuth potassium citrate containing quadruple therapy, Colloidal pectin bismuth capsules containing quadruple therapy and Colloidal pectin bismuth particles A quadruple therapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 1 siteChina
Study dates: 25 May 2020to 30 Aug 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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age between 18~75,both gender.
Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
Patients are willing to receive eradication treatment.
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 antibiotics to eradicate adequately recorded 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).
Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
Pregnant or lactating women.

Show all 15Show fewer

Underwent upper gastrointestinal Surgery.
Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
Evidence of bleeding or iron efficiency anemia.- Page 3 of 4 [DRAFT] -
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).
Patients who has psychological problem or poor compliance.
Enrolled in other clinical trials in the past 3 months.
Refuse to sign informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, 710032

Other trials in China

About this study

Official title: Comparison of Efficacy of Bismuth Potassium Citrate, Pectin Bismuth Capsules, and Pectin Bismuth Granules in the Treatment of Helicobacter Pylori (Hp) First-line Quadruple Regimen: a Multicenter, Randomized, Prospective, Comparative Clinical Trial

This study aims to compare efficacy and safety of bismuth-containing quadruple therapy（with rabeprazole amoxicillin clarithromycin）of different kinds of bismuth（Bismuth potassium citrate, pectin bismuth capsules, pectin bismuth particles）in H. pylori first-line eradication. It is hypothesized that different bismuth containing quadruple therapies have comparable eradication efficacy and safety. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2and 6 follow-up visits, a urea breath test(UBT) 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 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath 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 12 and 14.Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Conditions: Gastric Cancer, Helicobacter Pylori Infection, Bismuth
Being tested: Bismuth potassium citrate containing quadruple therapy, Colloidal pectin bismuth capsules containing quadruple therapy, Colloidal pectin bismuth particles A quadruple therapy, Colloidal pectin bismuth particles B quadruple therapy
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bismuth potassium citrate containing quadruple therapyDrug
Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID
Colloidal pectin bismuth capsules containing quadruple therapyDrug
Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID
Colloidal pectin bismuth particles A quadruple therapyDrug
Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID
Colloidal pectin bismuth particles B quadruple therapyDrug
Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID

Study groups in NCT04209933
Study group	Role	What they receive
Bismuth potassium citrate containing quadruple therapy	Active comparator	Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. Receives: Drug: Bismuth potassium citrate containing quadruple therapy; Drug: Colloidal pectin bismuth capsules containing quadruple therapy; Drug: Colloidal pectin bismuth particles A quadruple therapy; Drug: Colloidal pectin bismuth particles B quadruple therapy
Colloidal pectin bismuth capsules containing quadruple therapy	Active comparator	Colloidal pectin bismuth capsules 200 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. Receives: Drug: Bismuth potassium citrate containing quadruple therapy; Drug: Colloidal pectin bismuth capsules containing quadruple therapy; Drug: Colloidal pectin bismuth particles A quadruple therapy; Drug: Colloidal pectin bismuth particles B quadruple therapy
Colloidal pectin bismuth particles A quadruple therapy	Active comparator	Colloidal pectin bismuth particles 150 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. Receives: Drug: Bismuth potassium citrate containing quadruple therapy; Drug: Colloidal pectin bismuth capsules containing quadruple therapy; Drug: Colloidal pectin bismuth particles A quadruple therapy; Drug: Colloidal pectin bismuth particles B quadruple therapy
Colloidal pectin bismuth particles B quadruple therapy	Active comparator	Colloidal pectin bismuth particles 300 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days. Receives: Drug: Bismuth potassium citrate containing quadruple therapy; Drug: Colloidal pectin bismuth capsules containing quadruple therapy; Drug: Colloidal pectin bismuth particles A quadruple therapy; Drug: Colloidal pectin bismuth particles B quadruple therapy

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 28 days after the end of eradication.
Measured: 28 days after treatment]

Secondary outcomes (1)

symptoms effective rates
symptoms effective rates Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective 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. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3presenting most severe
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.

25 May 202030 Aug 2020

First posted24 Dec 2019
Study start25 May 2020
Primary completion1 Aug 2020
Study completion30 Aug 2020

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 Gastric CancerStudies 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: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04209933
Sponsor's protocol ID: KY20192146-C-1
Status last verified: Apr 2021
First submitted: 13 Dec 2019
Last updated: 8 Apr 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Cao Y, Zhang J, Liu Y, Zhang L, Wang L, Wang J, Qi Y, Lv H, Liu J, Huo L, Wei X, Shi Y. The efficacy and safety of different bismuth agents in Helicobacter pylori first-line eradication: A multicenter, randomized, controlled clinical trial. Medicine (Baltimore). 2021 Dec 17;100(50):e27923. doi: 10.1097/MD.0000000000027923.
PubMed 34918639

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Efficacy of Bismuth Potassium Citrate, Pectin Bismuth Capsules, and Pectin Bismuth Granules in the Treatment of Helicobacter Pylori (Hp) First-line Quadruple Regimen: a Multicenter, Randomized, Prospective, Comparative Clinical Trial
ClinicalTrials.gov ID: NCT04209933
Acronym / sponsor ID: KY20192146-C-1
Conditions: Gastric Cancer, Helicobacter Pylori Infection, Bismuth
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Xijing Hospital of Digestive DiseasesUniversity, hospital or other
Study start: 25 May 2020 (actual)
Primary completion: 1 Aug 2020 (actual)
Study completion: 30 Aug 2020 (actual)
First posted: 24 Dec 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Bismuth potassium citrate containing quadruple therapy	Active comparator	Drug: Bismuth potassium citrate containing quadruple therapy, Drug: Colloidal pectin bismuth capsules containing quadruple therapy, Drug: Colloidal pectin bismuth particles A quadruple therapy, Drug: Colloidal pectin bismuth particles B quadruple therapyBismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Colloidal pectin bismuth capsules containing quadruple therapy	Active comparator	Drug: Bismuth potassium citrate containing quadruple therapy, Drug: Colloidal pectin bismuth capsules containing quadruple therapy, Drug: Colloidal pectin bismuth particles A quadruple therapy, Drug: Colloidal pectin bismuth particles B quadruple therapyColloidal pectin bismuth capsules 200 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Colloidal pectin bismuth particles A quadruple therapy	Active comparator	Drug: Bismuth potassium citrate containing quadruple therapy, Drug: Colloidal pectin bismuth capsules containing quadruple therapy, Drug: Colloidal pectin bismuth particles A quadruple therapy, Drug: Colloidal pectin bismuth particles B quadruple therapyColloidal pectin bismuth particles 150 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
Colloidal pectin bismuth particles B quadruple therapy	Active comparator	Drug: Bismuth potassium citrate containing quadruple therapy, Drug: Colloidal pectin bismuth capsules containing quadruple therapy, Drug: Colloidal pectin bismuth particles A quadruple therapy, Drug: Colloidal pectin bismuth particles B quadruple therapyColloidal pectin bismuth particles 300 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age between 18~75,both gender.
Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
Patients are willing to receive eradication treatment.
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 antibiotics to eradicate adequately recorded 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).
Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.

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
Bismuth potassium citrate containing quadruple therapyBismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID	Drug	Bismuth potassium citrate containing quadruple therapy, Colloidal pectin bismuth capsules containing quadruple therapy, Colloidal pectin bismuth particles A quadruple therapy, Colloidal pectin bismuth particles B quadruple therapy
Colloidal pectin bismuth capsules containing quadruple therapyBismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID	Drug	Bismuth potassium citrate containing quadruple therapy, Colloidal pectin bismuth capsules containing quadruple therapy, Colloidal pectin bismuth particles A quadruple therapy, Colloidal pectin bismuth particles B quadruple therapy
Colloidal pectin bismuth particles A quadruple therapyBismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID	Drug	Bismuth potassium citrate containing quadruple therapy, Colloidal pectin bismuth capsules containing quadruple therapy, Colloidal pectin bismuth particles A quadruple therapy, Colloidal pectin bismuth particles B quadruple therapy
Colloidal pectin bismuth particles B quadruple therapyBismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID	Drug	Bismuth potassium citrate containing quadruple therapy, Colloidal pectin bismuth capsules containing quadruple therapy, Colloidal pectin bismuth particles A quadruple therapy, Colloidal pectin bismuth particles B 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 28 days after the end of eradication.

1 secondary outcome

symptoms effective rates
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 8 Apr 2021.
Derived from this study: PubMed 34918639Cao Y, Zhang J, Liu Y, Zhang L, Wang L, Wang J, Qi Y, Lv H, Liu J, Huo L, Wei X, Shi Y. The efficacy and safety of different bismuth agents in Helicobacter pylori first-line eradication: A multicenter, randomized, controlled clinical trial. Medicine (Baltimore). 2021 Dec 17;100(50):e27923. doi: 10.1097/MD.0000000000027923.
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?

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 8 Apr 2021. 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 NCT04209933, 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 8 Apr 2021.