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Ten Days Quadruple Versus Sequential Therapy as Empirical First and Second Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial


N/A
18 Years
N/A
Not Enrolling
Both
Helicobacter Pylori Infection

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Trial Information

Ten Days Quadruple Versus Sequential Therapy as Empirical First and Second Line Treatment for Helicobacter Pylori Eradication: a Randomized Crossover Trial


Helicobacter pylori (HP), a bacterium present in many people's stomachs, is one of the major
causes of ulcers and cancers. Up to 20% of patients infected with HP may develop peptic
ulcers. However, failure rate is rising due to multiple resistant HP infection. The
eradication rate of first line clarithromycin based therapy has fell to below 80% and
increasing number of patients also failed the second line quadruple therapy. The aim of this
clinical trial is to compare the efficacy and tolerability of H. pylori eradication with a
10-day quadruple therapy versus sequential therapy as empirical first and second line
treatment.

Methods: Eligible H. pylori positive patients were randomized to receive either QUAD
(esomeprazole 20mg twice daily, bismuth subcitrate 120mg four times daily, tetracycline
500mg four times daily and metronidazole 400mg four times daily) for 10 days or SEQ
(esomeprazole 20mg twice daily for 10 days, amoxicillin 1g twice daily for first 5 days,
clarithromycin 500mg twice daily and metronidazole 400mg four time daily for the subsequent
5 days). All patients returned 8 weeks after completing the treatment for a Urea Breath Test
(UBT) to confirm eradication. Patients who failed their respective therapy were crossover to
receive the alternative regimen.


Inclusion Criteria:



- patients with age 18 or above, diagnosed to have gastric HP infection

Exclusion Criteria:

- Patients with age less than 18, with past allergy to the study medications,
concurrent critical illnesses, a history of previous upper gastrointestinal surgery,
intake of nonsteroidal anti-inflammatory drugs, antibiotics, probiotics, bismuth
preparation, proton pump inhibitors, anticoagulants or steroids in the previous one
month, pregnant or breast-feeding women, drug abusers or alcoholic, history of
previous H. Pylori treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Helicobacter pylori eradication rate

Outcome Description:

Percentage of patients successfully eradicated Helicobacter pylori infection confirmed by urea breath test

Outcome Time Frame:

8 weeks after treatment

Safety Issue:

No

Principal Investigator

Ivan FN Hung, MD FRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Hong Kong

Authority:

Hong Kong: Ethics Committee

Study ID:

UW 11-221

NCT ID:

NCT01760824

Start Date:

May 2011

Completion Date:

December 2012

Related Keywords:

  • Helicobacter Pylori Infection
  • Sequential
  • Quadruple
  • First
  • Line
  • Helicobacter
  • pylori
  • infection
  • Helicobacter Infections

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