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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Inje University
Pacific Pharmaceuticals
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00841854
First received: February 10, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Helicobacter Infection
 Drug: pantoprazole
Drug: bismuth
Drug: metronidazole
Drug: tetracycline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of 7-Day and 14-Day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Whether the two week group yield a higher eradication rate comparing to the one week group. [ Time Frame: At least four week after completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • side effect [ Time Frame: four weeks after completion of medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: June 2008
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841854

Contacts
Contact: Jun-Won Chung, M.D. 82-2-3010-3188 junwonchung@hanmail.net

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Jun-Won Chung, M.D.     82-2-3010-3188     junwonchung@hanmail.net    
Sponsors and Collaborators
Asan Medical Center
Inje University
Pacific Pharmaceuticals
Investigators
Principal Investigator: Hwoon-Yong Jung, M.D Asan Medical Center
  More Information

No publications provided by Asan Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hwoon-Yong Jung M.D, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00841854     History of Changes
Other Study ID Numbers: 2008-0088
Study First Received: February 10, 2009
Last Updated: February 10, 2009
Health Authority: South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Helicobacter pylori
Bismuth
Salvage treatment
Metronidazole

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tetracycline
Metronidazole
Pantoprazole
Bismuth
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antacids
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 23, 2013