Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication

Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication.

At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.

Study Overview

• Status: Completed
• Conditions: Helicobacter Infection
• Intervention / Treatment: Drug: pantoprazole; Drug: bismuth; Drug: metronidazole; Drug: tetracycline

• Study Type: Interventional
• Enrollment (Actual): 199
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• H. pylori infection
• Aged between 18-80 years
• Are willing to received eradication therapy for H. pylori

Exclusion Criteria:

• Children and teenagers aged less than 18 years or over 80 years
• Previous eradication therapy for H. pylori
• History of gastrectomy
• Previous allergic reaction to antibiotics
• Use of prompt pump inhibitors and antibiotics in the recent 4 weeks
• Active upper GI bleeding in the recent 1 week
• Contraindication to treatment drugs
• Pregnant or lactating women
• Severe concurrent disease or malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PBMT7; pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days	Drug: pantoprazole; pantoprazole 40mg bid; Drug: bismuth; bismuth 300mg qid; Drug: metronidazole; metronidazole 500mg tid; Drug: tetracycline; tetracycline 500mg qid
Active Comparator: PBMT14; pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days	Drug: pantoprazole; pantoprazole 40mg bid; Drug: bismuth; bismuth 300mg qid; Drug: metronidazole; metronidazole 500mg tid; Drug: tetracycline; tetracycline 500mg qid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Whether the two week group yield a higher eradication rate comparing to the one week group.	At least four week after completion of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
side effect	four weeks after completion of medication

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Inje University; Pacific Pharmaceuticals
• Investigators: Principal Investigator: Hwoon-Yong Jung, M.D, Asan Medical Center

Publications and helpful links

General Publications

• Chung JW, Lee JH, Jung HY, Yun SC, Oh TH, Choi KD, Song HJ, Lee GH, Kim JH. Second-line Helicobacter pylori eradication: a randomized comparison of 1-week or 2-week bismuth-containing quadruple therapy. Helicobacter. 2011 Aug;16(4):289-94. doi: 10.1111/j.1523-5378.2011.00844.x.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: February 10, 2009
• First Submitted That Met QC Criteria: February 10, 2009
• First Posted (Estimate): February 11, 2009

Study Record Updates

• Last Update Posted (Estimate): December 6, 2016
• Last Update Submitted That Met QC Criteria: December 4, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Metronidazole; Helicobacter pylori; Bismuth; Salvage treatment
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Antacids; Metronidazole; Bismuth; Pantoprazole; Tetracycline
• Other Study ID Numbers: 2008-0088