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

Sequential Versus Concomitant Therapy for Helicobacter Pylori Infection

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Infection
• Intervention / Treatment: Drug: 10-day concomitant therapy; Drug: 10-day sequential treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 813
    • Kaohsiung Veterans General Hospital
  • Kaohsiung, Taiwan, 807
    • Chung-Ho Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Nexium-based sequential therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants in Which H. Pylori Was Eradicated	Evaluate eradication outcome by endoscopy urease test and histology or urea breath test	one month after finishing study drugs
Number of Participants Who Had Good Drug Compliance	Good drug compliance is defined as taking equal to or more than 80% of eradication medicines	one month after finishing test therapy

Collaborators and Investigators

• Sponsor: Kaohsiung Veterans General Hospital.
• Collaborators: Baylor College of Medicine
• Investigators: 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

Publications and helpful links

General Publications

• Francavilla R, Lionetti E, Castellaneta SP, Magista AM, Boscarelli G, Piscitelli D, Amoruso A, Di Leo A, Miniello VL, Francavilla A, Cavallo L, Ierardi E. Improved efficacy of 10-Day sequential treatment for Helicobacter pylori eradication in children: a randomized trial. Gastroenterology. 2005 Nov;129(5):1414-9. doi: 10.1053/j.gastro.2005.09.007.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: January 3, 2008
• First Submitted That Met QC Criteria: April 11, 2008
• First Posted (Estimate): April 14, 2008

Study Record Updates

• Last Update Posted (Estimate): September 30, 2015
• Last Update Submitted That Met QC Criteria: September 14, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: gastric cancer; therapeutics; peptic ulcer disease
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: KMU-IRB00003151; VGHKS95-CT3-11 (Other Grant/Funding Number: KaohsiungVGH)