Quadruple Versus Sequential Therapy for Helicobacter Pylori Eradication

NCT01760824 | Completed

• 1 other identifier: UW 11-221
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 1

Brief Summary

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 H. pylori may develop peptic ulcers. However, failure rate is rising due to multiple resistant H. pylori infection. The eradication rate of first line clarithromycin based therapy has fallen to below 80%. Both quadruple and sequential treatment regime has been proposed as the first-line empirical regime. Nevertheless, comparison in terms of efficacy and side effects between the two regime remained unknown. 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.

Conditions

Helicobacter Pylori Infection

Keywords

Sequential; Quadruple; First; Line; Helicobacter; pylori; infection

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication rate

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

  8 weeks after treatment

Secondary Outcomes (1)

• Development of side effects

  10 days

Study Arms (2)

Sequential therapy

EXPERIMENTAL

Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days

Drug: Sequential therapy; Drug: Quadruple therapy

Quadruple therapy

ACTIVE COMPARATOR

Esomeprazole 20mg bid, metronidazole 400mg aid, bismuth sub citrate 120mg aid and tetracycline 500mg qid, all for 10 days

Drug: Sequential therapy; Drug: Quadruple therapy

Interventions

Sequential therapy DRUG

Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days

Also known as: Esomeprazole (Nexium) 20mg bid for 10 days, Amoxicillin 1g bid for first 5 days, Clarithromycin (Klacid) 500mg bid for last 5 days, Metronidazole (Flagyl) 400mg qid for last 5 days

Quadruple therapy; Sequential therapy

Quadruple therapy DRUG

Esomeprazole 20mg bid, metronidazole 400mg qid, bismuth sub citrate 120mg qid and tetracycline 500mg qid, all for 10 days

Also known as: Esomeprazole (Nexium) 20mg bid, Metronidazole (Flagyl) 400mg qid, Bismuth subcitrate 120mg qid, Tetracycline 500mg qid, all for 10 days

Quadruple therapy; Sequential therapy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong, Queen Mary Hospital

Hong Kong SAR, Hong Kong

Location

Related Publications (1)

• Liu KS, Hung IF, Seto WK, Tong T, Hsu AS, Lam FY, But DY, Wong SY, Leung WK. Ten day sequential versus 10 day modified bismuth quadruple therapy as empirical firstline and secondline treatment for Helicobacter pylori in Chinese patients: an open label, randomised, crossover trial. Gut. 2014 Sep;63(9):1410-5. doi: 10.1136/gutjnl-2013-306120. Epub 2013 Dec 2.

  PMID: 24295850 DERIVED

MeSH Terms

Conditions

Infections

Interventions

Esomeprazole; BID protein, human; Amoxicillin; Clarithromycin; Metronidazole; bismuth tripotassium dicitrate; Tetracycline; Proto-Oncogene Proteins c-raf

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; raf Kinases; MAP Kinase Kinase Kinases; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Proto-Oncogene Proteins; Oncogene Proteins; Neoplasm Proteins

Study Officials

• Ivan FN Hung, MD FRCP

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: December 29, 2012
• First Posted: January 4, 2013
• Study Start: May 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 4, 2013

Record last verified: 2013-01

Locations

HK (1)