- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01938534
Prospective Study : Helicobacter Pylori Eradication Therapy in Accordance With Past Antibiotics Use
December 31, 2013 updated by: Sun Gyo Lim, Ajou University School of Medicine
Prospective study : Helicobacter pylori eradication therapy in accordance with past antibiotics use.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Antibiotics resistant is serious problem in helicobacter pylori eradication.
Clarithromycin is very important antibiotics in eradication.
But clarithromycin resistance is increased.
Major cause of clarithromycin resistance is past consumption of macrolide.
Thus the investigators propose eradication of macrolide used group bismuth contained four drugs therapy.
Study Type
Interventional
Enrollment (Anticipated)
440
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: Ki Myung Lee, M.D., Ph.D.
- Phone Number: 82-31-219-6939
- Email: lkm5104@ajou.ac.kr
Study Locations
-
-
-
Suwon, Korea, Republic of, 443-721
- Recruiting
- Ajou University Hospital
-
Principal Investigator:
- Kee Myung Lee, M.D., Ph.D.
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Peptic ulcer disease
- Gastric MALT lymphoma
- Early gastric cancer
- Familial history of gastric cancer
- Idiopathic iron deficiency
- Chronic idiopathic thrombocytopenia
- Atrophic gastritis
- Helicobacter infected dyspepsia
- Long term NSAIDs use
Exclusion Criteria:
- Pregnant
- Previous proton pump inhibitor, antibiotics or anticoagulant use within 2 weeks
- Previous stomach surgery
- Severe ill patients (heart failure, hepatic failure, renal failure, hematologic disorder, severe psychologic or neurologic disorder)
- Previous Helicobacter eradication
- Allergy for Helicobacter eradication medicine
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental
Omeprazole 30mg twice Clarithromycin 500mg twice Amoxicillin 1000mg twice for 10 days |
|
Active Comparator: Control
Tetracycline 500mg four times Omeprazole 30mg twice Bismuth 600mg twice Metronidazole 500mg three times for 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Eradication rate of Helicobacter pylori
Time Frame: one month
|
one month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
September 1, 2013
Primary Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
September 5, 2013
First Submitted That Met QC Criteria
September 9, 2013
First Posted (Estimate)
September 10, 2013
Study Record Updates
Last Update Posted (Estimate)
January 1, 2014
Last Update Submitted That Met QC Criteria
December 31, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- AJOU-EIRB-152692
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 Eradication
-
Kaohsiung Medical UniversityRecruiting
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingHelicobacter Pylori Eradication
-
Livzon Pharmaceutical Group Inc.CompletedHelicobacter Pylori Eradication
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityCompletedHelicobacter Pylori Eradication RateChina
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityShengjing Hospital; First People's Hospital of Foshan; Zhejiang University; Southern... and other collaboratorsNot yet recruiting
-
Shandong UniversityCompletedHelicobacter Pylori Eradication RateChina
-
Second Affiliated Hospital, School of Medicine,...RecruitingHelicobacter Pylori EradicationChina
-
Kaohsiung Medical UniversityRecruitingHelicobacter Pylori EradicationTaiwan
-
Ain Shams UniversityCompletedHelicobacter Pylori EradicationEgypt
-
Hangzhou Grand Biologic Pharmaceutical, Inc.The First Affiliated Hospital of Nanchang University; Xi'an Central Hospital; Nanjing First Hospital, Nanjing Medical University and other collaboratorsUnknown
Clinical Trials on Helicobacter pylori eradication
-
Shandong UniversityRecruitingHelicobacter Pylori InfectionChina
-
Shandong UniversityRecruitingHelicobacter Pylori InfectionChina
-
Fudan UniversityRecruitingHelicobacter Pylori Infection | MALT Lymphoma of StomachChina
-
The University of Texas Health Science Center,...Baylor College of Medicine; University of Texas; Texas Tech University; University...CompletedIron DeficiencyUnited States
-
National University of MalaysiaCompletedResponse to Levodopa | Motor Outcomes | Quality of Life OutcomesMalaysia
-
Seoul National University Bundang HospitalCompletedGastric CancerKorea, Republic of
-
National Cancer Center, KoreaCompletedGastric CancerKorea, Republic of
-
University of MalayaCompletedParkinson's Disease | Helicobacter Pylori InfectionMalaysia
-
Seoul National University HospitalCompletedGastric Tumor | Helicobacter Pylori | Endoscopic Resection | Metachronous NeoplasmsKorea, Republic of
-
National Taiwan University HospitalUnknown