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Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection (960025)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00656968
Recruitment Status : Completed
First Posted : April 14, 2008
Results First Posted : August 2, 2011
Last Update Posted : September 30, 2015
Baylor College of Medicine
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Brief Summary:

Helicobacter pylori is a bacteria that infects the lining of the stomach and is associated with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain forms of gastric cancer. Curing this infection generally requires that patients take 2 or more antibiotic medications and a stomach acid suppressing medication for about two weeks. Current treatments do not always cure the infection and a new treatment is being tested in this study. The drugs involved in the new 4 drug treatment have been widely used for treatment of this infection. It remains unknown what is the best and most cost effective way to give them. This study will compare three different ways of using these drugs.

Subjects must have active Helicobacter pylori infection in order to participate in this study.

Condition or disease Intervention/treatment Phase
Helicobacter Infection Drug: 10-day sequential treatment Drug: 10-day concomitant therapy Phase 4

Detailed Description:

The purpose of this study is to compare different methods of giving combination drug therapy for treating Helicobacter pylori infection of the stomach. The entire study will last less than 2 years. Each subject will be participating in the study for approximately 60 days.

A total of 360 subjects will be asked to participate in this study.

Before participating in this study, subject's must have undergone to confirm the presence and to assess the susceptibility of Helicobacter pylori. Qualified subjects will receive 4 drugs which are to be taken as part of the study treatment: an acid suppressing drug (name), amoxicillin, clarithromycin and metronidazole. The doses are 1 grams of amoxicillin, 40 mg of esomeprazole (Nexium), 500 mg of metronidazole and 250 mg of clarithromycin. Each drug will be given twice a day to be taken twice a day with the morning and evening meals. Subjects will receive one of three different combinations. The choice of which will be randomly chosen by the use of a computer program. The regimes are: all 4 drugs daily for 5 days, all 4 drugs daily for 10 days, and two drugs (esomeprazole and amoxicillin) for 5 days then all for drugs for 5 additional days.

Subjects will be asked to return within 4 days after completion of the treatment to evaluate how they did with the drugs. They will be asked bring back all unused medication and the bottles or containers that the medicine was packaged in. Your medication use and tolerance to the study drugs will be assessed. The treatment portion of the study will be complete at this point.

Evaluation of the effect of the treatment will take place 4-6 weeks after the end of therapy. Subjects will come back to the study site and will have a UBT or repeat endoscopy, if clinically indicated to verify that the Helicobacter pylori has been cured. Subjects will be asked not to take antibiotics or any other drugs that may affect the outcome of the breath test used to confirm that the treatment was successful.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Sequential Versus Concomitant Therapy for Helicobacter Pylori Infection
Study Start Date : May 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 10-day concomitant therapy
esomeprazole and amoxicillin and clarithromycin and metronidazole for 10 days
Drug: 10-day concomitant therapy
esomeprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 10, clarithromycin (500 mg, bid) from day 1 to day 10, metronidazole (500 mg, bid) from day 1 to day 10
Other Name: Nexium-based quadruple therapy

Experimental: 10-day sequential therapy
esomeprazole and amoxicillin for 5 days, followed by esoprazole and clarithromycin and metronidazole for 5 more days
Drug: 10-day sequential treatment
esomeprazole (40 mg daily) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, metronidazole (500 mg, bid) from day 6 to day 10
Other Name: Nexium-based sequential therapy

Primary Outcome Measures :
  1. Number of Participants in Which H. Pylori Was Eradicated [ Time Frame: one month after finishing study drugs ]
    Evaluate eradication outcome by endoscopy urease test and histology or urea breath test

  2. Number of Participants Who Had Good Drug Compliance [ Time Frame: one month after finishing test therapy ]
    Good drug compliance is defined as taking equal to or more than 80% of eradication medicines

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or non-pregnant female aged 18 to 75 years inclusively.
  • Mental and legal ability to give a written informed consent.
  • Active H. pylori infection.

Exclusion Criteria:

  • Previous surgery of the stomach such as partial gastrectomy.
  • Use of antibiotics within the preceding 30 days.
  • Regular use of bismuth compounds (>3 times per week) in the 30 days before enrollment.
  • Presence of serious medical condition(s) precluding participation or endoscopy with biopsy.
  • Use of concomitant medication(s) known to interact with study medication.
  • Presence of Zollinger-Ellison Syndrome.
  • Pregnancy or lactation.
  • Allergy to any of the study medications.
  • Contraindication(s) to the use of any of the study drugs.
  • Participation in a clinical trial within the last 30 days.
  • Unwillingness to abstain from alcoholic beverages.
  • Patients taking other medications including warfarin, antipsychotics, or chronic NSAIDs will also be excluded. Aspirin at a dose not more than 325 mg/day will be permitted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00656968

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Chung-Ho Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Baylor College of Medicine
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Study Chair: Ching-Kuan Liu, MD, PhD Kaohsiung Medical Univestity
Study Chair: David Y Graham, MD Baylor College of Medicine
Study Director: Antone R Opekun, PA-C Baylor College of Medicine
Principal Investigator: Deng-Chyang Wu, MD PhD Kaohsiung Medical University

Additional Information:
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Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital. Identifier: NCT00656968     History of Changes
Other Study ID Numbers: KMU-IRB00003151
VGHKS95-CT3-11 ( Other Grant/Funding Number: KaohsiungVGH )
First Posted: April 14, 2008    Key Record Dates
Results First Posted: August 2, 2011
Last Update Posted: September 30, 2015
Last Verified: September 2015

Keywords provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:
peptic ulcer disease
gastric cancer

Additional relevant MeSH terms:
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Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors