NCT02466919

Brief Summary

The study aims to evaluate H. pylori eradication rate in diabetic patients by using novel 10-day levofloxacin-based concomitant therapy compared with conventional 10-day sequential therapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2014

Typical duration for phase_4

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

May 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 17, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 9, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 2, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

May 17, 2015

Last Update Submit

September 1, 2016

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

  • Helicobacter pylori eradication rate

    C13-UBT to confirm the H. pylori eradication

    1-4 months after eradication therapy

Secondary Outcomes (6)

  • Acute inflammatory score

    1-4 weeks after gastric tissue obtained by upper endoscopy

  • Chronic inflammatory score

    1-4 weeks after gastric tissue obtained by upper endoscopy

  • H. pylori density score

    1-4 weeks after gastric tissue obtained by upper endoscopy

  • Intestinal metaplasia

    1-4 weeks after gastric tissue obtained by upper endoscopy

  • Spasmolytic polypeptide expressing metaplasia

    1-4 weeks after gastric tissue obtained by upper endoscopy

  • +1 more secondary outcomes

Study Arms (2)

Levofloxacin-based concomitant

EXPERIMENTAL

Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day10 Metronidazole 500 mg BID day1\~day10 Levofloxacin 500 mg QD day1\~day10

Drug: PantoprazoleDrug: AmoxicillinDrug: MetronidazoleDrug: Levofloxacin

Sequential

ACTIVE COMPARATOR

Pantoprazole 40 mg BID day1\~day10 Amoxicillin 1000 mg BID day1\~day5 Metronidazole 500 mg BID day6\~day10 Clarithromycin 500 mg BID day6\~day10

Drug: PantoprazoleDrug: AmoxicillinDrug: MetronidazoleDrug: Clarithromycin

Interventions

PantoprazoleDRUG

H. pylori eradication therapy

Also known as: Pantoloc
Levofloxacin-based concomitantSequential
AmoxicillinDRUG

H. pylori eradication therapy

Levofloxacin-based concomitantSequential
MetronidazoleDRUG

H. pylori eradication therapy

Also known as: Flagyl
Levofloxacin-based concomitantSequential
LevofloxacinDRUG

H. pylori eradication therapy

Also known as: Cravit
Levofloxacin-based concomitant
ClarithromycinDRUG

H. pylori eradication therapy

Also known as: Klaricid
Sequential

Eligibility Criteria

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

You may qualify if:

  • Diabetic patients with Helicobacter pylori infection

You may not qualify if:

  • Pregnancy or physically poor performance status
  • Patients with contraindication for upper endoscopy
  • Severe coagulopathy for endoscopic biopsy
  • Chronic kidney disease (eGFR \< 50) or end stage renal disease
  • Known allergy to interventional drugs
  • Previous eradication failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Yang YJ, Wu CT, Ou HY, Lin CH, Cheng HC, Chang WL, Chen WY, Yang HB, Lu CC, Sheu BS. Male non-insulin users with type 2 diabetes mellitus are predisposed to gastric corpus-predominant inflammation after H. pylori infection. J Biomed Sci. 2017 Oct 30;24(1):82. doi: 10.1186/s12929-017-0389-x.

    PMID: 29082856DERIVED

  • Yang YJ, Wu CT, Ou HY, Lin CH, Cheng HC, Chang WL, Chen WY, Yang HB, Lu CC, Sheu BS. Ten days of levofloxacin-containing concomitant therapy can achieve effective Helicobacter pylori eradication in patients with type 2 diabetes. Ann Med. 2017 Sep;49(6):479-486. doi: 10.1080/07853890.2017.1294761. Epub 2017 Mar 7.

    PMID: 28266875DERIVED

MeSH Terms

Interventions

PantoprazoleAmoxicillinMetronidazoleLevofloxacinClarithromycin

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesNitroimidazolesNitro CompoundsImidazolesAzolesOfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesErythromycinMacrolidesPolyketidesLactones

Study Officials

  • Yao-Jong Yang, PhD

    National Cheng-Kung University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
National Cheng-Kung University Hospital

Study Record Dates

First Submitted

May 17, 2015

First Posted

June 9, 2015

Study Start

May 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 2, 2016

Record last verified: 2016-09