Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy

Helicobacter Pylori Infection Clinical Trial

Official title:

Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy of Treatment of Helicobacter Pylori Infection in Korea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02108184
• Other study ID #: PSungmin
• Status: Recruiting
• Phase: Phase 4
• First received: February 26, 2014
• Last updated: February 23, 2016
• Start date: February 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: Incheon St.Mary's Hospital
• Contact: Sung min Park
• Phone: 082-032-280-5052
• Email: danson2000[@]hanmail.net
• Is FDA regulated: No
• Health authority: Republic of Korea : Korean Food and Drug association
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• Sequential therapy 10 days
(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 1
• 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 : Sequential therpay 2
• Concomitant therapy 10 days
(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg ) bid for 10 days : Concomitant therapy 1
• Concomitant therapy 14 days
(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days : Concomitant therapy 2

Locations

Country	Name	City	State
Korea, Republic of	Incheon St.Mary hospital	Incheon	Bupyung

Sponsors (1)

Lead Sponsor	Collaborator
Incheon St.Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Kim JS, Kim BW, Ham JH, Park HW, Kim YK, Lee MY, Ji JS, Lee BI, Choi H. Sequential Therapy for Helicobacter pylori Infection in Korea: Systematic Review and Meta-Analysis. Gut Liver. 2013 Sep;7(5):546-51. doi: 10.5009/gnl.2013.7.5.546. Epub 2013 Aug 14. — View Citation

Lim JH, Lee DH, Choi C, Lee ST, Kim N, Jeong SH, Kim JW, Hwang JH, Park YS, Lee SH, Shin CM, Jo HJ, Jang ES, Song Is, Jung HC. Clinical outcomes of two-week sequential and concomitant therapies for Helicobacter pylori eradication: a randomized pilot study. Helicobacter. 2013 Jun;18(3):180-6. doi: 10.1111/hel.12034. Epub 2013 Jan 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.	To assess Helicobacter pylori eradication rates	required average 10 weeks to assess Helicobacter pylori eradication rate from 1st visit	No