Efficacy of High Dose Dual Therapy, Sequential Therapy and Triple Therapy in H. Pylori Eradication

NCT01163435 | Completed Phase 4

• 1 other identifier: 200912093M
• Study Type: interventional
• Target: 618
• Locations: 1 country
• Sites: 1

Brief Summary

Up to now, to our knowledge, there is few randomized, large scale study prospectively and simultaneously comparing the efficacy, adverse effects and patient adherence of these current recommended 1st-line or 2nd-line regimens for H. pylori eradication in and out of our country. The aims of this study are:

1. 1.to compare the efficacy of high dose dual therapy, sequential therapy and clarithromycin-based triple therapy as 1st-line regimen in H. pylori eradication;
2. 2.to compare the efficacy of high dose dual therapy, sequential therapy and levofloxacin-based triple therapy as rescue regimen in H. pylori eradication;
3. 3.to compare the patient adherence and adverse effects of these treatment regimens;
4. 4.to investigate factors that may influence H. pylori eradication by these treatment regimens;
5. 5.to investigate and analyze the prevalence and trend of antibiotic resistance.

Conditions

Helicobacter Infection

Keywords

Helicobacter pylori; antibiotic resistance; high dose dual therapy; sequential therapy; clarithromycin-based triple therapy; levofloxacin-based triple therapy

Outcome Measures

Primary Outcomes (1)

• to compare the efficacy, adverse effects and patient adherence of high dose dual therapy, sequential therapy and clarithromycin-based triple therapy (or levofloxacin-based triple therapy) as 1st-line regimen (or rescue regimen) in H. pylori eradication

  The eradication rates (efficacy) will be evaluated by intention-to-treat (ITT) and per-protocol (PP) analysis. The safety and tolerability will be evaluated by the number of participant with adverse events and patient adherence (by counting unused medication after the treatment).

  3.5 years

Study Arms (4)

high dose dual therapy

EXPERIMENTAL

group A1 and A2 - high dose dual therapy (rabeprazole 20 mg qid, amoxicillin 750 mg qid for 14 days)

Drug: high dose dual therapy

sequential therapy

EXPERIMENTAL

group B1 and B2 - sequential therapy (rabeprazole 20 mg, amoxicillin 1000 mg, bid for 5 days, then rabeprazole 20 mg , metronidazole 500 mg, clarithromycin 500 mg, bid for next 5 days)

Drug: sequential therapy

clarithromycin-based triple therapy

ACTIVE COMPARATOR

group C1 - clarithromycin-based triple therapy (rabeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, bid for 7 days)

Drug: clarithromycin-based triple therapy

levofloxacin-based triple therapy

ACTIVE COMPARATOR

group C2 - levofloxacin-based triple therapy (rabeprazole 20 mg, amoxicillin 1000 mg, levofloxacin 250 mg, bid for 7 days)

Drug: levofloxacin-based triple therapy

Interventions

high dose dual therapy DRUG

rabeprazole 20 mg qid,amoxicillin 750 mg qid for 14 days

high dose dual therapy

sequential therapy DRUG

rabeprazole 20 mg, amoxicillin 1000 mg, bid for 5 days, then rabeprazole 20 mg , metronidazole 500 mg, clarithromycin 500 mg, bid for next 5 days

sequential therapy

clarithromycin-based triple therapy DRUG

rabeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, bid for 7 days

clarithromycin-based triple therapy

levofloxacin-based triple therapy DRUG

rabeprazole 20 mg, amoxicillin 1000 mg, levofloxacin 250 mg, bid for 7 days

levofloxacin-based triple therapy

Eligibility Criteria

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

You may qualify if:

• patients having H. pylori related chronic gastritis with/without peptic ulcers who are aged greater than 18 years and are willing to received eradication therapy.

You may not qualify if:

• pregnant or nursing woman
• serious concomitant illness and malignant tumor of any kind
• history of hypersensitivity to test drugs
• serious bleeding during the course of this ulcer
• previous gastric surgery
• receiving bismuth salts, proton pump inhibitors, or antibiotics in the previous month.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 10043, Taiwan

Location

Related Publications (1)

• Yang JC, Lin CJ, Wang HL, Chen JD, Kao JY, Shun CT, Lu CW, Lin BR, Shieh MJ, Chang MC, Chang YT, Wei SC, Lin LC, Yeh WC, Kuo JS, Tung CC, Leong YL, Wang TH, Wong JM. High-dose dual therapy is superior to standard first-line or rescue therapy for Helicobacter pylori infection. Clin Gastroenterol Hepatol. 2015 May;13(5):895-905.e5. doi: 10.1016/j.cgh.2014.10.036. Epub 2014 Nov 14.

  PMID: 25460556 DERIVED

MeSH Terms

Conditions

Helicobacter Infections

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Jyh-Chin Yang, M.D.Ph.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 15, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 3, 2013

Record last verified: 2013-12

Locations

TW (1)