Who is sponsoring NCT04122287?

NCT04122287 is sponsored by Shandong University.

What condition does NCT04122287 study?

NCT04122287 studies Helicobacter Pylori Infection.

What drugs are being tested in NCT04122287?

Interventions: Levofloxacin, tinidazole.

What is the status of NCT04122287?

NCT04122287 is currently UNKNOWN.

Last reviewed 2021-11-17 · How we verify

Helicobacter Pylori First-line Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study

NCT04122287 Phase 4 UNKNOWN

The purpose of this study is to assess and compare the effectiveness of levofloxacin-tetracycline -containing and tinidazole-tetracycline-containing quadruple regimens for the primary treatment of Helicobacter pylori infection in patients allergic to penicillin.

Details

Lead sponsor	Shandong University
Phase	Phase 4
Status	UNKNOWN
Enrolment	250
Start date	2019-11-01
Completion	2022-12

Conditions

Helicobacter Pylori Infection

Interventions

Levofloxacin
tinidazole

Primary outcomes

Eradication rates in 2 groups — 24 months
Both intention to treat(ITT) and per-protocol(PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

Countries

China