Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection

NCT01769365 | Completed Phase 4 Results DMC

• 1 other identifier: VGHKS99-CT7-10
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 1

Brief Summary

To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Complete Eradication of Helicobacter Pylori

  Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

  at the 6th week after the end of anti- H. pylori therapy

Study Arms (3)

7-day quadruple therapy

EXPERIMENTAL

1. pantoprazole 40 mg twice daily for 7 days, 2. clarithromycin 500 mg twice daily for 7 days, 3. amoxicillin 1 g twice daily for 7 days, 4. metronidazole 500 mg twice daily for 7 days

Drug: 7-day quadruple therapy

10-day sequential therapy

EXPERIMENTAL

1. pantoprazole 40 mg twice daily for 5 days and amoxicillin 1 g twice daily for 5 days, followed by 2. pantoprazole 40 mg twice daily for 5 days, clarithromycin 500 mg twice daily for 5 days, metronidazole 500 mg twice daily for 5 days.

Drug: 10-day sequential therapy

7-day standard triple therapy

ACTIVE COMPARATOR

1. pantoprazole 40 mg twice daily for 7 days, 2. clarithromycin 500 mg twice daily for 7 days, 3. amoxicillin 1 g twice daily for 7 days.

Drug: 7-day standard triple therapy

Interventions

7-day quadruple therapy DRUG

pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days

Also known as: Pantoprazole, amoxicillin, clarithromycin, metronidazole

7-day quadruple therapy

10-day sequential therapy DRUG

pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days

Also known as: sequential group

10-day sequential therapy

7-day standard triple therapy DRUG

pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days

Also known as: pantoprazole, clarithromycin, amoxicillin

7-day standard triple therapy

Eligibility Criteria

• Age: 20 Years - 90 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 20 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 proton pump inhibitors 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

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (1)

• Hsu PI, Wu DC, Chen WC, Tseng HH, Yu HC, Wang HM, Kao SS, Lai KH, Chen A, Tsay FW. Randomized controlled trial comparing 7-day triple, 10-day sequential, and 7-day concomitant therapies for Helicobacter pylori infection. Antimicrob Agents Chemother. 2014 Oct;58(10):5936-42. doi: 10.1128/AAC.02922-14. Epub 2014 Jul 28.

  PMID: 25070099 DERIVED

MeSH Terms

Interventions

Pantoprazole; Amoxicillin; Clarithromycin; Metronidazole

Intervention Hierarchy (Ancestors)

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

+886-7-3422121

Study Officials

• Ping-I Hsu, MD

  Kaohsiung Veterans General Hospital.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Division of Gastroenterology; Professor

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 16, 2013
• Study Start: July 1, 2010
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 17, 2017
• Results First Posted: October 6, 2015

Record last verified: 2015-09

Locations

TW (1)