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Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy

Information source: Incheon St.Mary's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Helicobacter Pylori Infection

Intervention: pantoprazole, amoxicillin, clarithromycin, metronidazole (Drug); pantoprazole, amoxicillin, clarithromycin, metronidazole (Drug); pantoprazole, amoxicillin, clarithromycin, metronidzole (Drug); pantoprazole, amoxicillin, clarithromycin, metronidazole (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Incheon St.Mary's Hospital

Overall contact:
Sung min Park, Phone: 082-032-280-5052, Email: danson2000@hanmail.net

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) bid for 10 days 2. (pantoprazole 40 mg + amoxicillin 1. 0g + clarithromycin 500 mg + metronidazole 500 mg) bid for 14 days 3. (pantoprazole 40 mg + amoxicillin 1. 0g) bid for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) bid for 5 days 4. (pantoprazole 40 mg + amoxicillin 1. 0g) bid for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) bid 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

Clinical Details

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

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

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

Eligibility

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 20~70 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

Locations and Contacts

Sung min Park, Phone: 082-032-280-5052, Email: danson2000@hanmail.net

Incheon St.Mary hospital, Incheon, Bupyung KSXX0009, Korea, Republic of; Recruiting
Sungmin Park
Additional Information

Related publications:

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.

Starting date: February 2014
Last updated: May 10, 2014

Page last updated: August 23, 2015

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