NCT04617613

Brief Summary

Eradication of H. pylori reduces morbidity in patients with chronic gastritis and can prevent gastric cancer. We aimed to evaluate the efficacy of clarithromycin-based triple therapy and non-bismuth based quadruple therapy for eradicating H. pylori in patients with chronic gastritis in Kuwait.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
603

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
Last Updated

November 5, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

October 29, 2020

Last Update Submit

October 30, 2020

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (2)

  • Negative 13-Carbon urea breath test

    H. pylori eradication rate defined as negative 13-Carbon urea breath test (13C-UBT) one month after treatment

    One month

  • Adverse events

    Any reported adverse events during the study period

    One month

Study Arms (2)

Standard triple therapy

ACTIVE COMPARATOR

Standard triple therapy group received omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg twice daily for 14 days.

Drug: Omeprazole, Amoxicillin and Clarithromycin

Quadruple therapy group

EXPERIMENTAL

Quadruple therapy group received omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily after meals for 14 days.

Drug: Omeprazole, Amoxicillin, Metronidazole and Clarithromycin

Interventions

Omeprazole, Amoxicillin, Metronidazole and ClarithromycinDRUG

The first group (standard triple therapy group) received omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg. The second group (quadruple therapy group) received omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg. Patients in both groups received omeprazole capsule twice daily before meals and the rest of the drugs twice daily after meals for 14 days.

Also known as: Quadruple therapy group
Quadruple therapy group
Omeprazole, Amoxicillin and ClarithromycinDRUG

The first group (standard triple therapy group) received omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg. The second group (quadruple therapy group) received omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg. Patients in both groups received omeprazole capsule twice daily before meals and the rest of the drugs twice daily after meals for 14 days.

Also known as: Standard triple therapy
Standard triple therapy

Eligibility Criteria

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

You may qualify if:

  • Male and female dyspeptic subjects aged ≥18 years with any nationality
  • Patients with gastric biopsy-proven H. pylori related chronic gastritis and no other abnormalities in the upper gastrointestinal tract upon endoscopy
  • Patients who were naive to treatment for H. pylori infection.

You may not qualify if:

  • Pregnant or breastfeeding females
  • Patients who were previously treated for H. pylori infection
  • Patients who received any antibiotics, bismuth or acid-suppressant drugs within the last month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alfadhli A, Alboraie M, Afifi M, Dangi A. A Randomized Clinical Trial Comparing Triple Therapy versus Non-bismuth based Quadruple Therapy for the Eradication of Helicobacter Pylori in Kuwait. J Glob Infect Dis. 2022 Aug 26;14(3):99-105. doi: 10.4103/jgid.jgid_13_22. eCollection 2022 Jul-Sep.

    PMID: 36237565DERIVED

MeSH Terms

Interventions

OmeprazoleAmoxicillinMetronidazoleClarithromycin

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate clinical researcher

Study Record Dates

First Submitted

October 29, 2020

First Posted

November 5, 2020

Study Start

September 1, 2016

Primary Completion

September 1, 2018

Study Completion

December 1, 2019

Last Updated

November 5, 2020

Record last verified: 2020-10