Sequential and Hybrid Therapies for H Pylori Infection

NCT01085786 | Completed Phase 4 Results DMC

• 1 other identifier: VGHKS97-CT6-08
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants in Which H. Pylori Was Eradicated

  evaluate eradication outcome by endoscopy with urease test or urea breath test

  Dec 2010

Secondary Outcomes (2)

• Adverse Events

  Dec 2010

• Compliance Rate

  Dec 2010

Study Arms (2)

14-day sequential treatment

ACTIVE COMPARATOR

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 hybrid treatment

EXPERIMENTAL

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

Interventions

14-day sequential treatment DRUG

* 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

Also known as: Esomeprazole, amoxicillin, clarithromycin, metronidazole

14-day sequential treatment

14-day hybrid treatment DRUG

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

Also known as: esomeprazole + amoxicillin, then quadruple therapy

14-day hybrid treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead
• Baylor College of Medicine: collaborator
• Kaohsiung Medical University: collaborator

Study Sites (2)

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, 813, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Interventions

Esomeprazole; Amoxicillin; Clarithromycin; Metronidazole

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

Limitations and Caveats

The trial was performed in a single country.

Results Point of Contact

• Title: Dr. Ping-I Hsu
• Organization: Kaohsiung Veterans General Hospital

pihsu@isca.vghks.gov.tw

886-7-3462121

Study Officials

• Kwok-Hung Lai, PhD

  Kaohsiung Veterans General Hospital.

  STUDY CHAIR

• David Y Graham, MD

  Baylor College of Medicine

  STUDY DIRECTOR

• PING-I Hsu, MD, PhD

  Kaohsiung Veterans General Hospital.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 12, 2010
• Study Start: August 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 21, 2015
• Results First Posted: May 6, 2011

Record last verified: 2015-09

Locations

TW (2)