Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori

This study is currently recruiting participants.

Verified May 2012 by Shanghai Jiao Tong University School of Medicine

Sponsor:

Information provided by (Responsible Party):

Dr. HONG LU, Shanghai Jiao Tong University School of Medicine

ClinicalTrials.gov Identifier:

NCT01667575

First received: August 15, 2012

Last updated: December 12, 2012

Last verified: May 2012

History of Changes

Purpose

The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.

Condition	Intervention	Phase
Functional Dyspepsia Peptic Ulcer Helicobacter Pylori	Drug: Esomeprazole Drug: Amoxicillin Drug: Clarithromycin Drug: Bismuth Potassium Citrate Other: long duration (14 day)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:

Eradication rate of Helicobacter pylori [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
To calculate and compare the efficacy of 10 day and 14 day triple therapies with and without bismuth,to examine whether long duration and addition of bismuth affects the eradication.

Estimated Enrollment:	180
Study Start Date:	August 2012
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 10 day Quadruple Therapy Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days	Drug: Esomeprazole antisecretary drug of the quadruple therapy Other Name: proton pump inhibitor Drug: Amoxicillin antibiotic of the quadruple therapy Other Name: antibiotic Drug: Clarithromycin antibiotic of the quadruple therapy Other Name: antibiotic Drug: Bismuth Potassium Citrate one of a component of a quadruple therapy Other Name: Bismuth
Active Comparator: 10 day Triple therapy Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days	Drug: Esomeprazole antisecretary drug of the quadruple therapy Other Name: proton pump inhibitor Drug: Amoxicillin antibiotic of the quadruple therapy Other Name: antibiotic Drug: Clarithromycin antibiotic of the quadruple therapy Other Name: antibiotic
Active Comparator: 14 day quadruple therapy Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days	Drug: Esomeprazole antisecretary drug of the quadruple therapy Other Name: proton pump inhibitor Drug: Amoxicillin antibiotic of the quadruple therapy Other Name: antibiotic Drug: Clarithromycin antibiotic of the quadruple therapy Other Name: antibiotic Drug: Bismuth Potassium Citrate one of a component of a quadruple therapy Other Name: Bismuth Other: long duration (14 day)

Detailed Description:

The success rate of currently recommended triple therapy with a proton pump inhibitor (PPI) plus amoxicillin and clarithromycin has fallen into the unacceptable range. The purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for H.pylori treatment, while ten day triple therapy is used as control.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

patients who presented with upper gastrointestinal symptoms and endoscopically proven H.pylori-positive functional dyspepsia and scarred peptic ulcers

Exclusion Criteria:

patients less than 18 years old, with history of H. pylori infection treatment, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks, or allergy to any one of the given medication in the regimens.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667575

Locations

China, Shanghai
Renji Hospital	Recruiting
Shanghai, Shanghai, China, 200127
Contact: Xiao Liang 86-21-58752345 ext 33114 lxleung@yahoo.com.cn

Sponsors and Collaborators

Shanghai Jiao Tong University School of Medicine

Investigators

Principal Investigator:

Hong Lu, M.D.

Shanghai Jiao Tong University School of Medicine

More Information

No publications provided

Responsible Party:	Dr. HONG LU, Professor of GI Division, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:	NCT01667575 History of Changes
Other Study ID Numbers:	rjkls2012004
Study First Received:	August 15, 2012
Last Updated:	December 12, 2012
Health Authority:	China: Food and Drug Administration

Additional relevant MeSH terms:

Dyspepsia
Peptic Ulcer
Ulcer
Signs and Symptoms, Digestive
Signs and Symptoms
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Amoxicillin
Anti-Bacterial Agents
Clarithromycin
Bismuth

Omeprazole
Potassium Citrate
Proton Pump Inhibitors
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Protein Synthesis Inhibitors
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013

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