NCT05728424

Brief Summary

  1. 1.To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan.
  2. 2.To assess the improvement in the quality of life of patients receiving Vonoprazan as part of the triple regimen.

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
246

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_3

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

September 20, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

January 9, 2023

Last Update Submit

February 5, 2023

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • Efficacy of triple therapy in eradication of H.pylori (based on duration)

    a) To assess the efficacy of the duration of Vonoprazan based triple regimen (one versus two weeks), in the eradication of H-pylori among patients attending gastroenterology clinics of Karachi, Pakistan. The eradication of H.pylori will be tested using the Urea breath test 6 weeks post treatment.

    6 months

Secondary Outcomes (1)

  • Quality of life assessment using QoLRAD (quality of life in reflux and dyspepsia)

    6 months

Study Arms (2)

2 weeks vonoprazan containing triple regimen

ACTIVE COMPARATOR

For two weeks: Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily

Drug: Vonoprazan, Amoxicillin, Levofloxacin

1 week vonoprazan containing triple regimen

PLACEBO COMPARATOR

For One week: Vonaprazan: 20 mg twice daily Amoxicillin: 1gm twice daily Levofloxacin: 500 mg once daily For the second week: Placebo

Drug: Vonoprazan, Amoxicillin, Levofloxacin

Interventions

Vonoprazan, Amoxicillin, LevofloxacinDRUG

No additional information

1 week vonoprazan containing triple regimen2 weeks vonoprazan containing triple regimen

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years
  • H pylori infection confirmed by any of the 3 tests C-urea breath test (UBT), , rapid urease test, and stool H pylori antigen.

You may not qualify if:

  • acute gastrointestinal disease (e.g., acute diarrhea)
  • chronic gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease)
  • known renal and/or liver failure
  • no known malignancy
  • varices bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamineAmoxicillinLevofloxacin

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsOfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolines

Central Study Contacts

Shahab abid, MBBS, PhD

CONTACT

923333965940shahab.abid@aku.edu

Muhammad Qasim Chaudhry, MBBS

CONTACT

923009506815Chaudhry.qasim@alumni.aku.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Of Medicine

Study Record Dates

First Submitted

January 9, 2023

First Posted

February 15, 2023

Study Start

September 20, 2022

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

PA(1)