Helicobacter Pylori Eradication RatePhase 4NCT02776371
Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori
A Phase 4 study testing Modified non-clarithromycin triple therapy and Sequential therapy in people with Helicobacter Pylori Eradication Rate, run by Shandong University at 1 site in China.
Trial summary
Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Eradication Rate
- What is being tested?
- Modified non-clarithromycin triple therapy and Sequential therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Feb 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who were intend to undergo upper endoscopy for any purpose and volunteered to written inform consent.
Who cannot join
- negative in rapid urease test (RUT)
- previous standard eradication therapy for H. pylori;
- history of esophagectomy or gastrectomy;
- gastrointestinal malignancy;
- contraindications or allergic to study drugs;
- user of taking medicine that may affect the result of the study within 4 weeks (e.g., proton-pump inhibitors, H2-receptor antagonists, bismuth or antibiotics etc.);
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- cardiopulmonary, hepatic or renal insufficiency, and/or severe current diseases or malignancy;
- pregnant or lactating women;
- participants of other trial within the past 3 months;
- unwilling or unable to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China.
- Conditions
- Helicobacter Pylori Eradication Rate
- Being tested
- Modified non-clarithromycin triple therapy, Sequential therapy
- Keywords
- Helicobacter pylori, Sequential therapy, Modified non-clarithromycin triple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified non-clarithromycin triple therapyDrug
- pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.
Sequential therapyDrug
- pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Modified non-clarithromycin triple therapy | Experimental | H.pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days. Receives: Drug: Modified non-clarithromycin triple therapy |
| Sequential therapy | Active comparator | H.pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days. Receives: Drug: Sequential therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference of eradication rates between 2 groups
Measured: 5 months
Secondary outcomes (1)
the different rates of adverse events between 2 groups
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Eradication RateStudies 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
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Li Yanqing, MD, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776371
- Sponsor's protocol ID
- 2016SDU-QILU-05
- Status last verified
- Dec 2018
- First submitted
- 15 May 2016
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT02776371
- Acronym / sponsor ID
- 2016SDU-QILU-05
- Conditions
- Helicobacter Pylori Eradication Rate
- Keywords
- Helicobacter pylori, Sequential therapy, Modified non-clarithromycin triple therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 18 May 2016 (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.
Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified non-clarithromycin triple therapy | Experimental | Drug: Modified non-clarithromycin triple therapyH.pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days. |
| Sequential therapy | Active comparator | Drug: Sequential therapyH.pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who were intend to undergo upper endoscopy for any purpose and volunteered to written inform consent.
Key exclusion criteria (10 listed)
- negative in rapid urease test (RUT)
- previous standard eradication therapy for H. pylori;
- history of esophagectomy or gastrectomy;
- gastrointestinal malignancy;
- contraindications or allergic to study drugs;
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 |
|---|---|---|
| Modified non-clarithromycin triple therapyH. pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days. | Drug | Modified non-clarithromycin triple therapy |
| Sequential therapyH. pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days. | Drug | Sequential therapy |
Primary outcome
the difference of eradication rates between 2 groups
Time frame: 5 months
1 secondary outcome
the different rates of adverse events between 2 groups
Time frame: 5 months
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 24 Dec 2018.
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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.
Li Yanqing, MD, PhD principal investigator
Qilu Hospital of Shandong University
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 Modified non-clarithromycin triple therapy and Sequential therapy in people with Helicobacter Pylori Eradication Rate, run by Shandong University 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 10 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 24 Dec 2018. 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?
the difference of eradication rates between 2 groups (time frame: 5 months). 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 24 Dec 2018.