Sequential and Hybrid Therapies for H Pylori Infection

• ClinicalTrials.gov Identifier: NCT01085786
• Recruitment Status: Completed
• First Posted: March 12, 2010
• Results First Posted: May 6, 2011
• Last Update Posted: September 21, 2015
• Sponsor: Kaohsiung Veterans General Hospital.
• Collaborators: Baylor College of Medicine; Kaohsiung Medical University
• Information provided by (Responsible Party): Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Study Description

Brief Summary:

Primary: To evaluate efficacy of 14 day 2-phase sequential therapy given in two forms. One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. The alternate will be similar with the exception that the amoxicillin will be continued throughout the 14 days. The secondary endpoint is to evaluate the effectiveness of therapy in relation to antibiotic resistance.

Condition or disease	Intervention/treatment	Phase
Helicobacter Pylori Infection	Drug: 14-day sequential treatment; Drug: 14-day hybrid treatment	Phase 4

Detailed Description:

The purpose of this study is to test whether the 14-day sequential therapy ( esomeprazole plus amoxicillin dual therapy for 7 days followed by triple therapy with esomeprazole, clarithromycin, and metronidazole for 7 days) or 14-day hybird therapy (esomeprazole plus amoxicillin dual therapy for 7 days followed by quadruple therapy with esomeprazole, amoxicillin, clarithromycin, and metronidazole for 7 days) can achieve an eradication rate equal to or more than 95%.

A total of 240 subjects will be asked to participate in this study.

H. pylori-infected patients are randomized to either a 14-day sequential therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days) or a hybrid therapy (esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days).

Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the end of anti-H. pylori therapy. The eradication rates of the two study groups will be compared.

A successful regimen is defined as a regimen achieving an eradication rate equal to or more than 95%.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of 14-day Sequential and Hybrid Therapies for H Pylori Infection
• Study Start Date: August 2008
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 14-day sequential treatment; One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.	Drug: 14-day sequential treatment; 14-day sequential therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days; 14-day hybrid therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days; Other Name: Esomeprazole, amoxicillin, clarithromycin, metronidazole
Experimental: 14-day hybrid treatment; esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days	Drug: 14-day hybrid treatment; esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days; Other Name: esomeprazole + amoxicillin, then quadruple therapy

Outcome Measures

Primary Outcome Measures :

1. Number of Participants in Which H. Pylori Was Eradicated [ Time Frame: Dec 2010 ]
   evaluate eradication outcome by endoscopy with urease test or urea breath test

Secondary Outcome Measures :

1. Adverse Events [ Time Frame: Dec 2010 ]
   by standardized questionnaire
2. Compliance Rate [ Time Frame: Dec 2010 ]
   Good compliance is defined as taking equal or more than 90% of eradication medicines

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• consecutive H. pylori-infected outpatients, at least 18 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

• previous H. pylori-eradication therapy
• ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks
• patients with allergic history to the medications used
• patients with previous gastric surgery
• the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
• pregnant women.

Contacts and Locations

Locations

Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 813

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan

Sponsors and Collaborators

Kaohsiung Veterans General Hospital.

Baylor College of Medicine

Kaohsiung Medical University

Investigators

• Study Chair: Kwok-Hung Lai, PhD; Kaohsiung Veterans General Hospital.
• Study Director: David Y Graham, MD; Baylor College of Medicine
• Principal Investigator: PING-I Hsu, MD, PhD; Kaohsiung Veterans General Hospital.

More Information

• Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.
• ClinicalTrials.gov Identifier: NCT01085786
• Other Study ID Numbers: VGHKS97-CT6-08
• First Posted: March 12, 2010
• Results First Posted: May 6, 2011
• Last Update Posted: September 21, 2015
• Last Verified: September 2015

Keywords provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:

Helicobacter pylori infection

Additional relevant MeSH terms:

Infections; Communicable Diseases; Disease Attributes; Pathologic Processes; Amoxicillin; Metronidazole; Clarithromycin; Esomeprazole; Anti-Bacterial Agents; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Protein Synthesis Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors