Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy

Phase 4

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Sequential therapy 10 days; Drug: Sequential therapy 14 days; Drug: Concomitant therapy 10 days; Drug: Concomitant therapy 14 days

• Registration Number: NCT02108184
• Lead Sponsor: Incheon St.Mary's Hospital

Brief Summary

Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.

single center, randomized trial

1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 10 days

2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 14 days

3. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days

4. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days

1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol) 2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-04-05
• Study First Posted: 2014-04-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-25
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• 20~80 patients
• agreement of informed consent
• H.pylori positive (biopsy, CLO)
• Peptic ulcer disease, mucosa associated lymphoid tissue lymphoma, Post endoscopic submucosal dissection status due to early gastric cancer

Exclusion Criteria

• H.pylori eradication history
• severe hepatic, renal, cardiac failure
• pregnancy, participant of other study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential therapy 10 days	Sequential therapy 10 days	1.(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 5 days
Sequential therapy 14 days	Sequential therapy 14 days	(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days
Concomitant therapy 10 days	Concomitant therapy 10 days	(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 10 days
Concomitant therapy 14 days	Concomitant therapy 14 days	(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days

Primary Outcome Measures

Name	Time	Method
Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.	required average 10 weeks to assess Helicobacter pylori eradication rate from 1st visit	To assess Helicobacter pylori eradication rates

Trial Locations

Locations (1)

Incheon St.Mary hospital; 🇰🇷 Incheon, Bupyung, Korea, Republic of