Rescue Therapy for Helicobacter Pylori Eradication Treatment

NCT04531059 | Completed Phase 4 DMC

• 1 other identifier: rjkls2019013
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 3

Brief Summary

Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. This study aimed to compare the efficacy and tolerability of a 14-day bismuth-containing quadruple rescue therapy in which tetracycline was replaced by minocycline.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; rescue therapy; minocycline; tetracycline

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

  Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (\<4‰) (4‰ as the cutoff value).

  Six weeks after completion of therapy

Secondary Outcomes (2)

• Rate of adverse effects

  Within 7 days after completion of therapy

• Compliance rate

  Within 7 days after completion of therapy

Study Arms (2)

Tetracycline Bismuth Quadruple Therapy

ACTIVE COMPARATOR

Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Tetracycline 500mg qid Metronidazole 400mg qid

Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Tetracycline,Metronidazole

Minocycline Bismuth Quadruple Therapy

EXPERIMENTAL

Esomeprazole 20mg bid Bismuth Potassium Citrate 600mg bid Minocycline 100mg bid Metronidazole 400mg qid

Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Minocycline,Metronidazole

Interventions

Esomeprazole DRUG

Proton pump inhibitor

Minocycline Bismuth Quadruple Therapy; Tetracycline Bismuth Quadruple Therapy

Bismuth Potassium Citrate DRUG

Gastric mucosal protective drug with anti-H. pylori effect

Minocycline Bismuth Quadruple Therapy; Tetracycline Bismuth Quadruple Therapy

Tetracycline,Metronidazole DRUG

Antibiotics for H. pylori eradication

Tetracycline Bismuth Quadruple Therapy

Minocycline,Metronidazole DRUG

Antibiotics for H. pylori eradication

Minocycline Bismuth Quadruple Therapy

Eligibility Criteria

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

You may qualify if:

• Ability and willingness to participate in the study and to sign and give informed consent
• Confirmed H. pylori infection and with previous treatment failure

You may not qualify if:

• subjects naive to H. pylori treatment,
• under 18 or over 80 years old
• history of gastrectomy
• pregnant or lactating women
• severe systemic diseases or malignancy
• administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks
• contraindications to the study drugs

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (3)

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

Location

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

The Second Affiliated Hospital of Zhejiang University school of Medicine

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

cyclopia sequence

Interventions

Esomeprazole; Tetracycline; Metronidazole; Minocycline

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; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles

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: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 28, 2020
• Study Start: October 15, 2020
• Primary Completion: December 20, 2022
• Study Completion: December 31, 2022
• Last Updated: December 30, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)