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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01265069
• Other study ID #: 201005064M
• Status: Recruiting
• Phase: Phase 4
• First received: December 10, 2010
• Last updated: May 31, 2013
• Start date: November 2010
• Est. completion date: December 2013

Study information

• Verified date: May 2013
• Source: National Taiwan University Hospital
• Contact: Jyh-Chin Yang, M.D.Ph.D
• Phone: 886-2-23123456
• Email: jcyang47[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• high dose dual therapy
rabeprazole 20mg qid,amoxicillin 750mg qid for 14days
• concomitant therapy
rabeprazole 20 mg,amoxicillin 1000 mg,metronidazole 500 mg,clarithromycin 500 mg, bid for 10 days

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to compare the efficacy of 10-day concomitant regimen versus high dose dual therapy used as atni-Helicobacter pylori rescue therapy	The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis.	1.5 years	Yes
Secondary	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	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).	1.5 years	Yes