Comparing the Efficacy of Reverse Hybrid Therapy and Concomitant Therapy

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: dexlan+clarith+amox+metro; Drug: (dexlan+amox+clar+metr)+(dexlan+amox)

Study type: Interventional

Funder types: Other

Identifiers

NCT02646332

VGHKS15-CT7-15

Details and patient eligibility

About

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

Full description

A 14-day hybrid therapy invented by our study group appears very promising in H. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. Recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. However, whether reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.

Enrollment: 248 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

248 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

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

dexlan+clarith+amox+metro

Active Comparator group

Description:

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

Treatment:

Drug: dexlan+clarith+amox+metro