Helicobacter Pylori InfectionPhase 4NCT04432233
Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease
A Phase 4 study testing Esomeprazole, Metronidazole and Levofloxacin in people with Helicobacter Pylori Infection and Intravenous Drug Usage, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Helicobacter pylori infection causes active peptic ulcer disease and related complications like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter pylori infection after active peptic ulcer disease and related complicaitons getting healed, which spent time and money. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection, Intravenous Drug Usage
- What is being tested?
- Esomeprazole, Metronidazole and Levofloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2020to 15 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged between 18 and 75 years old
- Without previous Helicobacter pylori treatment
- Diagnosed with active peptic ulcer disease and related complications like bleeding and pyloric obstruction by endoscopy examination
- Ability and willingness to participate in the study and to sign and give informed consent
- Positive for Helicobacter pylori IgM antibody
Who cannot join
- With previous gastric surgery
- Major systemic diseases
- Pregnancy or lactation
- Allergy to any of the study drugs
- Decline to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Xiao Liang, PHD,MD, 13120839615, xliang5515@gmail.com
About this study
Official title: Intravenous Administration of Metronidazole, Levofloxacin and Esomeprazole Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease
Helicobacter pylori infection causes active peptic ulcer disease and related complications like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter pylori infection after active peptic ulcer disease and related complicaitons getting healed, which spent time and money. This study is designed to evaluate the efficacy and safety of intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in the treatment of Helicobacter pylori infection combined with peptic ulcer disease related complications.
- Being tested
- Esomeprazole, Metronidazole, Levofloxacin
- Keywords
- Helicobacter Pylori Infection, Intravenous Drug Usage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Proton pump inhibitor
MetronidazoleDrug
antibiotic for H. pylori eradication
LevofloxacinDrug
antibiotic for H. pylori eradication
| Study group | Role | What they receive |
|---|---|---|
| Intravenous therapy | Experimental | Subjected enrolled will receive (a) a 10-day intravenous triple therapy containing esomeprazole 40 mg thrice a day, metronidazole 500 mg twice a day and levofloxacin 500 mg once a day and (b) esomeprazole 20 mg twice a day taken orally for 8 weeks. Receives: Drug: Esomeprazole; Drug: Metronidazole; Drug: Levofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
Measured: Six weeks after completion of therapy
Secondary outcomes (3)
Rate of adverse effects
Measured: Within 7 days after completion of therapy
Rate of stop bleeding
Measured: Within 7 days after completion of therapy
Rate of pyloric obstruction remission
Measured: Within 7 days after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start15 Jun 2020
- Primary completion15 Apr 2021 (estimated)
- Study completion15 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
- Investigators
- Hong Lu, PHD,MD, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiao Tong University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432233
- Sponsor's protocol ID
- rjkls2020031
- Status last verified
- Aug 2020
- First submitted
- 11 Jun 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Administration of Metronidazole, Levofloxacin and Esomeprazole Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease
- ClinicalTrials.gov ID
- NCT04432233
- Acronym / sponsor ID
- rjkls2020031
- Keywords
- Helicobacter Pylori Infection, Intravenous Drug Usage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Apr 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 16 Jun 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.
Helicobacter pylori infection causes active peptic ulcer disease and related complications like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter pylori infection after active peptic ulcer disease and related complicaitons getting healed, which spent time and money. This study is designed to evaluate the efficacy and safety of intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in the treatment of Helicobacter pylori infection combined with peptic ulcer disease related complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravenous therapy | Experimental | Drug: Esomeprazole, Drug: Metronidazole, Drug: LevofloxacinSubjected enrolled will receive (a) a 10-day intravenous triple therapy containing esomeprazole 40 mg thrice a day, metronidazole 500 mg twice a day and levofloxacin 500 mg once a day and (b) esomeprazole 20 mg twice a day taken orally for 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged between 18 and 75 years old
- Without previous Helicobacter pylori treatment
- Diagnosed with active peptic ulcer disease and related complications like bleeding and pyloric obstruction by endoscopy examination
- Ability and willingness to participate in the study and to sign and give informed consent
- Positive for Helicobacter pylori IgM antibody
Key exclusion criteria (5 listed)
- With previous gastric surgery
- Major systemic diseases
- Pregnancy or lactation
- Allergy to any of the study drugs
- Decline to participate in the study
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 |
|---|---|---|
| EsomeprazoleProton pump inhibitor | Drug | Intravenous therapy |
| Metronidazoleantibiotic for H. pylori eradication | Drug | Intravenous therapy |
| Levofloxacinantibiotic for H. pylori eradication | Drug | Intravenous therapy |
Primary outcome
Helicobacter pylori eradication rate
Time frame: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
3 secondary outcomes
Rate of adverse effects
Time frame: Within 7 days after completion of therapy
Rate of stop bleeding
Time frame: Within 7 days after completion of therapy
Rate of pyloric obstruction remission
Time frame: Within 7 days after completion of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, 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.
Hong Lu, PHD,MD principal investigator
Renji Hospital, School of Medicine, Shanghai Jiao Tong 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 Esomeprazole, Metronidazole and Levofloxacin in people with Helicobacter Pylori Infection and Intravenous Drug Usage, run by Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 5 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 27 Aug 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Liang, PHD,MD (13120839615, xliang5515@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication rate (time frame: Six weeks after completion of therapy). 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 27 Aug 2020.