- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04432233
Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease
August 25, 2020 updated by: Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiao Liang, PHD,MD
- Phone Number: 13120839615
- Email: xliang5515@gmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200127
- Recruiting
- Renji Hospital, School of Medicine, Shanghai Jiao Tong University
-
Contact:
- Xiao Liang, PHD,MD
- Phone Number: 13120839615
- Email: xliang5515@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- With previous gastric surgery
- Major systemic diseases
- Pregnancy or lactation
- Allergy to any of the study drugs
- Decline to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intravenous therapy
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.
|
Proton pump inhibitor
antibiotic for H. pylori eradication
antibiotic for H. pylori eradication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Six weeks after completion of therapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of adverse effects
Time Frame: Within 7 days after completion of therapy
|
Within 7 days after completion of therapy
|
Rate of stop bleeding
Time Frame: Within 7 days after completion of therapy
|
Within 7 days after completion of therapy
|
Rate of pyloric obstruction remission
Time Frame: Within 7 days after completion of therapy
|
Within 7 days after completion of therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hong Lu, PHD,MD, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2020
Primary Completion (Anticipated)
April 15, 2021
Study Completion (Anticipated)
June 15, 2021
Study Registration Dates
First Submitted
June 11, 2020
First Submitted That Met QC Criteria
June 12, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Actual)
August 27, 2020
Last Update Submitted That Met QC Criteria
August 25, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease Attributes
- Gastrointestinal Diseases
- Stomach Diseases
- Intestinal Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Duodenal Diseases
- Infections
- Communicable Diseases
- Helicobacter Infections
- Peptic Ulcer
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Gastrointestinal Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Cytochrome P-450 CYP1A2 Inhibitors
- Anti-Infective Agents, Urinary
- Renal Agents
- Metronidazole
- Levofloxacin
- Ofloxacin
- Esomeprazole
Other Study ID Numbers
- rjkls2020031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Helicobacter Pylori Infection
-
Bangabandhu Sheikh Mujib Medical University, Dhaka...RecruitingHelicobacter Pylori Infection | Helicobacter Pylori EradicationBangladesh
-
Shandong UniversityRecruitingHelicobacter Pylori Infection | Patient Education | Helicobacter Pylori EradicationChina
-
Shandong UniversityCompletedHelicobacter Pylori Infection Helicobacter Pylori Eradication Patient EducationChina
-
Shanghai Jiao Tong University School of MedicineCompletedCure Rate of Helicobacter Pylori InfectionChina
-
Seoul National University Bundang HospitalRecruitingHelicobacter Pylori Infection | Helicobacter Pylori 23S rRNA Clarithromycin Resistance Mutation | Helicobacter Pylori Associated Gastrointestinal Disease | Helicobacter Pylori Infection, Susceptibility toKorea, Republic of
-
The First Affiliated Hospital of Nanchang UniversityUnknownBacterial Infection Due to Helicobacter Pylori (H. Pylori) | Eradication Therapy of Helicobacter Pylori | Detection of Helicobacter PyloriChina
-
Tanta UniversityNot yet recruitingPersistent Helicobacter Pylori InfectionEgypt
-
Nanjing First Hospital, Nanjing Medical UniversityCompletedHelicobacter Pylori 23S rRNA/gyrA Gene Mutation Detection Kit (Fluorescence PCR Fusion Curve Method)Helicobacter Pylori Infection | Helicobacter Pylori gyrA Levofloxacin Resistance Mutation | Fecal Drug Resistance Gene Detection | Helicobacter Pylori Infection, Susceptibility toChina
-
National University Hospital, SingaporeUnknownHELICOBACTER PYLORI INFECTIONSSingapore
-
Kaohsiung Veterans General Hospital.Kaohsiung Medical University Chung-Ho Memorial HospitalCompletedHelicobacter Pylori InfectionTaiwan
Clinical Trials on Esomeprazole
-
TakedaCompletedHealthy ParticipantsUnited States
-
Chinese University of Hong KongCompletedBleeding | Peptic UlcerChina
-
National Taiwan University HospitalMinistry of Science and Technology, Taipei, TaiwanCompleted
-
AstraZenecaCompletedRefractory Reflux EsophagitisJapan
-
Bio-innova Co., LtdNot yet recruiting
-
Onconic Therapeutics Inc.Completed
-
Bio-innova Co., LtdNot yet recruiting
-
AstraZenecaCompletedGastroesophageal Reflux Disease (GERD)United States, France, Poland, Germany
-
Chinese University of Hong KongTerminatedGastrointestinal HemorrhageChina
-
Chong Kun Dang PharmaceuticalCompleted