NCT05018923

Brief Summary

This randomized controlled clinical trial will evaluate the efficacy and safety of proton pump inhibitor, bismuth, metronidazole, and either tetracycline or doxycycline for Helicobacter pylori rescue treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
242

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

August 24, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

August 22, 2021

Last Update Submit

August 24, 2021

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • Eradication rate of Helicobacter pylori

    Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value).

    At least 4 weeks after completion of therapy

Secondary Outcomes (2)

  • Eradication rate of Helicobacter pylori resistant strains

    At least 4 weeks after completion of therapy

  • Eradication rate of Helicobacter pylori susceptible strains

    At least 4 weeks after completion of therapy

Other Outcomes (2)

  • Adherence rate

    2 weeks during therapy

  • Frequency of adverse events

    2 weeks during therapy

Study Arms (2)

RBMD group

EXPERIMENTAL

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and doxycycline 0.1 g bid for 14 days

Drug: RabeprazoleDrug: Bismuth potassium citrateDrug: MetronidazoleDrug: Doxycycline

RAMT group

ACTIVE COMPARATOR

Rabeprazole 20 mg bid, bismuth potassium citrate 0.6 g bid, metronidazole 0.4 g qid and tetracycline 0.5 g qid for 14 days

Drug: RabeprazoleDrug: Bismuth potassium citrateDrug: MetronidazoleDrug: Tetracycline

Interventions

RabeprazoleDRUG

20mg bid

RAMT groupRBMD group
Bismuth potassium citrateDRUG

0.6g bid

RAMT groupRBMD group
MetronidazoleDRUG

0.4g qid

RAMT groupRBMD group
DoxycyclineDRUG

0.1g bid

RBMD group
TetracyclineDRUG

0.5g qid

RAMT group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
  • years old on the day of signing the ICF.
  • Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
  • Have failed eradication treatment before.

You may not qualify if:

  • Have not received Hp eradication treatment.
  • Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
  • Subjects or guardians refused to participate in the trial.
  • Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
  • Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
  • Pregnant or lactating women.
  • Active peptic ulcer.
  • allergic to drugs used in the trial.
  • any other circumstances that are not suitable for recruitment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Interventions

RabeprazoleMetronidazoleDoxycyclineTetracycline

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingNitroimidazolesNitro CompoundsImidazolesAzolesTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Taotao Liu, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi Chen, MD

CONTACT

86-17811921405chenqimd@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2021

First Posted

August 24, 2021

Study Start

August 24, 2021

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

August 26, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available from the principal investigator Taotao Liu at liu.taotao@zs-hospital.sh.cn, beginning 6 months and ending 5 years after the trial results were published. The study protocol and statistical analysis plan are available online from https://clinicaltrials.gov/. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 6 months and ending 5 years after the trial results were published.
Access Criteria
All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of all investigators before data release.
More information

Locations

CN(1)