CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Clarithromycin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02892409
NCT02892409Phase 1Completed
CompareCT.gov

A Phase 1, Double-Blind, Parallel Group Study to Evaluate the Safety and Pharmacokinetics of Quadruple Therapy (Bismuth, Clarithromycin, and Amoxicillin) With TAK-438 Versus Quadruple Therapy With Lansoprazole

Takeda·interventional·Posted Sep 8, 2016·Updated Jan 3, 2019

In Brief

A Phase 1 clinical trial evaluating Clarithromycin, Amoxicillin, and 3 other interventions for Helicobacter Pylori. Completed, enrolled 30 participants across 1 site.

Detailed Summary

To evaluate the safety, tolerability, and pharmacokinetics (PK) of quadruple therapy with bismuth, clarithromycin, amoxicillin, and TAK-438 versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and lansoprazole.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHelicobacter Pylori
CountriesSouth Korea
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 8, 2016
Enrollment StartSep 5, 2016
Primary CompletionApr 17, 2017
Study CompletionMay 11, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 9.8 years ago

Interventions

Clarithromycindrug

Clarithromycin tablets

Amoxicillindrug

Amoxicillin capsules

Tripotassium bismuth dicitratedrug

Tripotassium bismuth dicitrate tablets

Lansoprazoledrug

Lansoprazole capsules

TAK-438drug

TAK-438 tablets