Efficacy of 10-day Concomitant Regimen Versus High Dose Dual Therapy in Anti-Helicobacter Pylori Rescue Therapy

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Currently, a 10-day concomitant therapy has been reported to be equally effective and safe to the 10-day sequential therapy for 1st-line anti-Helicobacter pylori(H. pylori) therapy. To our knowledge, there has been no report concerning the efficacy of this regimen used as a rescue therapy.

The aims of this study are:

1. to compare the efficacy of high dose dual therapy and concomitant therapy as rescue regimen in H. pylori eradication;
2. to compare the patient adherence and adverse effects of these treatment regimens;
3. to investigate factors that may influence H. pylori eradication by these treatment regimens.

Condition or disease	Intervention/treatment	Phase
Helicobacter Pylori Infection	Drug: high dose dual therapy; Drug: concomitant therapy	Phase 4

Detailed Description:

Patients, aged 18, having H. pylori-positive chronic gastritis with/without peptic ulcers will be recruited. All undergo endoscopy with biopsy before treatment. Four to eight weeks after termination of treatment, H. pylori infection status will be examined by endoscopy with biopsy or the Carbon 13-urea breath test if the patients refuse the second endoscopy. The cytochrome P450 (CYP)2C19 genotype of each participant will be analyzed by the polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP) method. A computed generated random numbers sequence will be blocked into two subgroups, say A and B.

If the patients had received anti-H. pylori therapy previously, they will be invited to enter the study for evaluating the efficacy of rescue regimens. After giving their written informed consent, all patients will be labeled with numbers by enrolling order. Each patient will be randomly allocated to one of two treatment groups which receives medications for 10 to 14 days:

group A - high dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days); group B - concomitant therapy (rabeprazole 20 mg + amoxicillin 1000 mg + metronidazole 500 mg + clarithromycin 500 mg, bid for 10 days).

All patients will be asked to complete a questionnaire and to record symptoms and drug consumption daily in a diary card during the treatment period. Post-treatment, the patients will be seen at the Outpatient Clinic to investigate patient adherence and adverse effects of treatment.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	204 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Efficacy of 10-day Concomitant Regimen Versus High Dose Dual Therapy in Anti-Helicobacter Pylori Rescue Therapy
Study Start Date :	November 2010
Estimated Primary Completion Date :	June 2013
Estimated Study Completion Date :	December 2013

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: high dose dual therapy; Group A - high dose dual therapy (rabeprazole 20 mg qid, amoxicillin 750 mg qid for 14 days)	Drug: high dose dual therapy; rabeprazole 20mg qid,amoxicillin 750mg qid for 14days
Experimental: concomitant therapy; Group B - concomitant therapy (rabeprazole 20 mg, amoxicillin 1000 mg, metronidazole 500 mg, clarithromycin 500 mg, bid for 10 days).	Drug: concomitant therapy; rabeprazole 20 mg,amoxicillin 1000 mg,metronidazole 500 mg,clarithromycin 500 mg, bid for 10 days

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. to compare the efficacy of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy [ Time Frame: 1.5 years ]
   The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.

Secondary Outcome Measures :

1. to compare the adverse effects and patient adherence of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy [ Time Frame: 1.5 years ]
   The safety and tolerability will be evaluated by the number of participant with adverse events and patient adherence (by counting unused medication after the treatment and record symptoms in a diary card).

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• patients having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 18 years and are willing to received eradication therapy.

Exclusion Criteria:

• pregnant or nursing woman
• serious concomitant illness and malignant tumor of any kind
• history of hypersensitivity to test drugs
• serious bleeding during the course of this ulcer
• previous gastric surgery
• receiving bismuth salts, proton pump inhibitors, or antibiotics in the previous month.

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Jyh-Chin Yang, M.D.Ph.D	886-2-23123456 ext 65055	jcyang47@ntu.edu.tw

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan, 10043
Contact: Jyh-Chin Yang, M.D.Ph.D. 886-2-23123456 ext 65055 jcyang47@ntu.edu.tw

Sponsors and Collaborators

National Taiwan University Hospital

National Science Council, Taiwan

Investigators

Principal Investigator:	Jyh-Chin Yang, M.D.Ph.D.	National Taiwan University Hospital

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT01265069 History of Changes
Other Study ID Numbers:	201005064M
First Posted:	December 22, 2010
Last Update Posted:	June 3, 2013
Last Verified:	May 2013

Keywords provided by National Taiwan University Hospital:

Helicobacter pylori; concomitant therapy; high dose dual therapy; antibiotic resistance

Additional relevant MeSH terms:

Helicobacter Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Amoxicillin; Rabeprazole; Anti-Bacterial Agents	Anti-Infective Agents; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action