Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy

NCT02547038 | Completed Results DMC

• 1 other identifier: VGHKS15-CT2-10
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

Reverse hybrid therapy achieves a higher eradication rate than bismuth quadruple therapy remained unanswered.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Eradication rate

Outcome Measures

Primary Outcomes (1)

• Number of Participants in Which H. Pylori Was Eradicated

  Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori)

  sixth week after the end of anti- H. pylori therapy

Study Arms (2)

pantoprazole+bismuth+tetra+metro

EXPERIMENTAL

pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

Drug: pantoprazole+bismuth+tetra+metro

(panto+amox+clar+metr)+(panto+amox)

ACTIVE COMPARATOR

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Drug: (panto+amox+clar+metr)+(panto+amox)

Interventions

pantoprazole+bismuth+tetra+metro DRUG

pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

Also known as: pantoprazole 40 mg, bismuth subcitrate 120 mg, tetracycline 500 mg, metronidazole 250 mg

pantoprazole+bismuth+tetra+metro

(panto+amox+clar+metr)+(panto+amox) DRUG

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Also known as: pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg, metronidazole 500 mg

(panto+amox+clar+metr)+(panto+amox)

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 or bismuth 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 (32)

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MeSH Terms

Interventions

Pantoprazole; bismuth tripotassium dicitrate; Tetracycline; Metronidazole; Amoxicillin; Clarithromycin

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; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

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@vghks.gov.tw

+886-7-3422121

Study Officials

• Ping-I Hsu, Bachelor

  Kaohsiung Veterans General Hospital.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2015
• First Posted: September 11, 2015
• Study Start: February 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: June 10, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-03

Locations

TW (1)