NCT01742429

Brief Summary

To test the efficacy of 14 day levofloxacin and bismuth-containing second-line therapy for resistant Helicobacter pylori infection, to compare with the classical quadruple therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 2, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 29, 2014

Status Verified

June 1, 2013

Enrollment Period

5 months

First QC Date

December 2, 2012

Last Update Submit

August 28, 2014

Conditions

Cure Rate of Helicobacter Pylori Infection

Keywords

Helicobacter pylorisecond line treatment

Outcome Measures

Primary Outcomes (1)

  • eradication rate

    urease breath test

    2 months

Study Arms (2)

Levofloxacin-bismuth therapy

EXPERIMENTAL

14 day levofloxacin and bismuth-containing therapy:PPI,bismuth, amoxicillin, levofloxacin

Drug: Proton pump inhibitorDrug: Bismuth subsalicylateDrug: AmoxicillinDrug: Levofloxacin

classical quadruple therapy

ACTIVE COMPARATOR

14 day classical quadruple therapy:PPI,bismuth, metronidazole, tetracycline

Drug: Proton pump inhibitorDrug: Bismuth subsalicylateDrug: MetronidazoleDrug: Tetracycline

Interventions

Proton pump inhibitorDRUG
Levofloxacin-bismuth therapyclassical quadruple therapy
Bismuth subsalicylateDRUG
Levofloxacin-bismuth therapyclassical quadruple therapy
MetronidazoleDRUG

antibiotic

classical quadruple therapy
TetracyclineDRUG

antibiotic

classical quadruple therapy
AmoxicillinDRUG

antibiotic

Levofloxacin-bismuth therapy
LevofloxacinDRUG

antibiotic

Levofloxacin-bismuth therapy

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all patients had failed H.pylori therapies including clarithromycin, metronidazole and/or amoxicillin (if not allergic) before.

You may not qualify if:

  • patients less than 18 years old,
  • previous gastric surgery,
  • pregnancy,
  • lactation,
  • major systemic diseases,
  • administration of antibiotics,
  • bismuth,
  • antisecretory drugs in the preceding 8 weeks, or
  • allergy to any one of the medication used in the quadruple regimens.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Interventions

Proton Pump Inhibitorsbismuth subsalicylateMetronidazoleTetracyclineAmoxicillinLevofloxacin

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingOfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolines

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
Prof. of Medicine

Study Record Dates

First Submitted

December 2, 2012

First Posted

December 5, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

August 29, 2014

Record last verified: 2013-06

Locations

CN(1)