Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection

NCT00656968 | Completed Phase 4 Results

• 2 other identifiers: KMU-IRB00003151VGHKS95-CT3-11
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 2

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.

Conditions

Helicobacter Infection

Keywords

peptic ulcer disease; gastric cancer; therapeutics

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

10-day concomitant therapy

ACTIVE COMPARATOR

esomeprazole and amoxicillin and clarithromycin and metronidazole for 10 days

Drug: 10-day concomitant therapy

10-day sequential therapy

EXPERIMENTAL

esomeprazole and amoxicillin for 5 days, followed by esoprazole and clarithromycin and metronidazole for 5 more days

Drug: 10-day sequential treatment

Interventions

10-day sequential treatment DRUG

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

Also known as: Nexium-based sequential therapy

10-day sequential therapy

10-day concomitant therapy DRUG

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

Also known as: Nexium-based quadruple therapy

10-day concomitant therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead
• Baylor College of Medicine: collaborator

Study Sites (2)

Chung-Ho Hospital

Kaohsiung, Taiwan, 807, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 16285942 BACKGROUND

MeSH Terms

Conditions

Helicobacter Infections; Peptic Ulcer; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Limitations and Caveats

The trial was performed in a single country

Results Point of Contact

• Title: Dr. Ping-I Hsu
• Organization: Kaohsiung Veterans General Hospital

pihsu@isca.vghks.gov.tw

886-7-3422121

Study Officials

• Ching-Kuan Liu, MD, PhD

  Kaohsiung Medical Univestity

  STUDY CHAIR

• David Y Graham, MD

  Baylor College of Medicine

  STUDY CHAIR

• Antone R Opekun, PA-C

  Baylor College of Medicine

  STUDY DIRECTOR

• Deng-Chyang Wu, MD PhD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: April 14, 2008
• Study Start: May 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: September 30, 2015
• Results First Posted: August 2, 2011

Record last verified: 2015-09

Locations

TW (2)