NCT02894268

Brief Summary

Doxycycline- and Furazolidone-containing Quadruple Regimen can be a successful rescue treatment for Helicobacter pylori Infection patients after Failure of several therapy. It is superior of tailored therapy as rescue treatment for helicobacter pylori Infection after failure of several therapy.

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
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2016

Longer than P75 for phase_4

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

Study Start

First participant enrolled

February 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

August 25, 2016

Last Update Submit

September 4, 2018

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • H. pylori eradication rate

    Repeat 13-Urea breath test 42 days after H.pylori eradication

    42 days after start of therapy

Secondary Outcomes (3)

  • Clinical response as measured by Number of participants whose symptoms disappear or improve after eradication treatment

    14 days and 42 days after H.pylori eradication

  • Side effects

    14 days after start of therapy

  • Adherence rate

    14 days after start of therapy

Study Arms (2)

Regimen A

EXPERIMENTAL

esomeprazole (E) 20 mg, doxycycline (D) 100mg, furazolidone (F) 100 mg, and colloidal bismuth subcitrate (B) 100 mg

Drug: DoxycyclineDrug: FurazolidoneDrug: EsomeprazoleDrug: Colloidal Bismuth Subcitrate

Regimen B

ACTIVE COMPARATOR

two sensitivity antibiotics based on antibiotic sensitivity of helicobacter pylori culture, colloidal bismuth subcitrate (B) 100 mg, esomeprazole (E) 20 mg

Drug: EsomeprazoleDrug: Colloidal Bismuth SubcitrateDrug: Sensitivity antibiotics

Interventions

DoxycyclineDRUG

Doxycycline 100g po bid

Also known as: Vibramycin
Regimen A
FurazolidoneDRUG

Furazolidone 100mg po bid

Also known as: Giarlan
Regimen A
EsomeprazoleDRUG

Esomeprazole 20mg po bid

Also known as: Nexium
Regimen ARegimen B
Colloidal Bismuth SubcitrateDRUG

Bismuth 20mg po bid

Also known as: PIDI
Regimen ARegimen B
Sensitivity antibioticsDRUG

Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.

Regimen B

Eligibility Criteria

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

You may qualify if:

  • A positive 13 C-urea breath test
  • Formal H.pylori treatment more than two times
  • Age \>18 years

You may not qualify if:

  • Bismuth compounds, acid inhibitor, or antibiotics during 4 weeks before the patient is enrolled
  • Allergic to the medications
  • Upper gastrointestinal surgery history
  • Serious heart insufficiency, liver insufficiency, renal insufficiency and other serious medical problems
  • Evidence of blood dyscrasia
  • Pregnant and lactating women
  • Can't express his complain correctly and can't cooperate with the researcher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Run Run Shaw Hospital,Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (2)

  • Zhang Y, Gao W, Cheng H, Zhang X, Hu F. Tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for Helicobacter pylori infection: a single center retrospective study. Helicobacter. 2014 Oct;19(5):382-6. doi: 10.1111/hel.12143. Epub 2014 May 21.

    PMID: 24849129BACKGROUND

  • Ciccaglione AF, Cellini L, Grossi L, Manzoli L, Marzio L. A Triple and Quadruple Therapy with Doxycycline and Bismuth for First-Line Treatment of Helicobacter pylori Infection: A Pilot Study. Helicobacter. 2015 Oct;20(5):390-6. doi: 10.1111/hel.12209. Epub 2015 Mar 20.

    PMID: 25801708RESULT

MeSH Terms

Interventions

DoxycyclineFurazolidoneEsomeprazolebismuth tripotassium dicitrate

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsNitrofuransNitro CompoundsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFuransOmeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsPyridinesBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Weiling Hu, Attending

    Sir Run Run Shaw Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Dai, Chief

CONTACT

+86138-6745-76642267454962@qq.com

Weiling Hu, Attending

CONTACT

+86153-9705-9751ringwh@163.com

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
Clinical Professor

Study Record Dates

First Submitted

August 25, 2016

First Posted

September 9, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2018

Study Completion

December 1, 2019

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)