NCT02646332

Brief Summary

Reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

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

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
3 months until next milestone

Results Posted

Study results publicly available

November 24, 2020

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

4.7 years

First QC Date

January 4, 2016

Results QC Date

November 1, 2020

Last Update Submit

November 1, 2020

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriEradication rate

Outcome Measures

Primary Outcomes (1)

  • Number of Participants in Which H. Pylori Was Eradicated

    To assess eradication efficacy,repeated endoscopy with rapid urease test, histological examination and culture or Urea breath test.

    sixth week after the end of anti- H. pylori therapy

Study Arms (2)

(dexlan+amox+clar+metr)+(dexlan+amox)

EXPERIMENTAL

a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily

Drug: (dexlan+amox+clar+metr)+(dexlan+amox)

dexlan+clarith+amox+metro

ACTIVE COMPARATOR

dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days

Drug: dexlan+clarith+amox+metro

Interventions

(dexlan+amox+clar+metr)+(dexlan+amox)DRUG

a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily

Also known as: dexlansoprazole MR 60 mg, amoxicillin 1 g, clarithromycin 500 mg, metronidazole 250 mg
(dexlan+amox+clar+metr)+(dexlan+amox)
dexlan+clarith+amox+metroDRUG

dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days

Also known as: dexlansoprazole MR 60 mg, clarithromycin 500 mg, amoxicillin 1 g, metronidazole 250 mg
dexlan+clarith+amox+metro

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

You may not qualify if:

  • previous H pylori-eradication therapy
  • ingestion of antibiotics or bismuth within the prior 4 weeks
  • patients with allergic history to the medications used
  • patients with previous gastric surgery
  • the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

MeSH Terms

Interventions

AmoxicillinClarithromycinMetronidazole

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesNitroimidazolesNitro CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Limitations and Caveats

The trial was performed in a single country

Results Point of Contact

Title
Dr. Ping-I Hsu
Organization
Kaohsiung Veterans General Hospital
williamhsup@yahoo.com.tw
+886-7-3422121

Study Officials

  • Ping-I Hsu, Bachelor

    Kaohsiung Veterans General Hospital.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 4, 2016

First Posted

January 5, 2016

Study Start

December 1, 2015

Primary Completion

July 31, 2020

Study Completion

August 31, 2020

Last Updated

November 24, 2020

Results First Posted

November 24, 2020

Record last verified: 2020-11

Locations

TW(1)