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

Sponsor:	Asan Medical Center
Collaborators:	Inje University Pacific Pharmaceuticals
Information provided by:	Asan Medical Center
ClinicalTrials.gov Identifier:	NCT00841854

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Comparison of 7-Day and 14-Day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication.

Resource links provided by NLM:

Drug Information available for: Tetracycline Tetracycline hydrochloride Metronidazole hydrochloride Metronidazole phosphate Pantoprazole Pantoprazole Sodium Metronidazole Bismuth

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
PBMT7: Active Comparator 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
PBMT14: Active Comparator 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

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

Keywords provided by Asan Medical Center:

Helicobacter pylori
Bismuth
Salvage treatment
Metronidazole

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Metronidazole
Antiprotozoal Agents
Molecular Mechanisms of Pharmacological Action
Pantoprazole
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors
Helicobacter Infections
Infection

Tetracycline
Pharmacologic Actions
Gram-Negative Bacterial Infections
Bismuth
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Antiparasitic Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Anti-Ulcer Agents
Antacids

ClinicalTrials.gov processed this record on February 08, 2010