Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy

• ClinicalTrials.gov Identifier: NCT01792700
• Recruitment Status: Completed
• First Posted: February 15, 2013
• Last Update Posted: February 15, 2013
• Sponsor: Seoul National University Bundang Hospital
• Information provided by (Responsible Party): Nayoung Kim, Seoul National University Bundang Hospital

Tracking Information

• First Submitted Date: February 12, 2013
• First Posted Date: February 15, 2013
• Last Update Posted Date: February 15, 2013
• Study Start Date: January 2003
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 14, 2013): Helicobacter pylori reinfection rate [ Time Frame: From date of randomization until the date of first documented reinfection of Helicobacter pylori, whichever came first, assessed up to 90 months ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long-term Follow up Helicobacter Pylori Reinfection Rate After Second-Line Treatment: Bismuth-Containing Quadruple Therapy Versus Moxifloxacin-Based Triple Therapy
• Official Title: Not Provided
• Brief Summary: patients who had failed previous H. pylori eradication on standard triple therapy were randomized into two regimens: 1, esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d) (EBMT) or 2, moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.) (MEA). At four weeks after completion of eradication therapy, H. pylori tests were performed with 13C urea breath test (UBT) or invasive tests (Giemsa histology, CLO test, and culture). In patients who maintained continuous H. pylori negativity for the first year after eradication therapy, H. pylori status was assessed every year. For the evaluation of risk factors of reinfection, gender, age, clinical diagnosis, histological atrophic gastritis or intestinal metaplasia were analyzed.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Helicobacter Infections

Intervention

• Drug: esomeprazole
• Drug: tripotassium dicitrate bismuthate
• Drug: metronidazole
• Drug: tetracycline
• Drug: moxifloxacin
• Drug: amoxicillin

Study Arms

• Active Comparator: MEA
  MEA: moxifloxacin (400 mg q.d.), esomeprazole (20 mg b.i.d), and amoxicillin (1000 mg b.i.d.)
  Interventions:

  • Drug: esomeprazole
  • Drug: moxifloxacin
  • Drug: amoxicillin
• Active Comparator: EBMT
  EBMT: esomeprazole (20 mg b.i.d), tripotassium dicitrate bismuthate (300 mg q.i.d), metronidazole (500 mg t.i.d), and tetracycline (500 mg q.i.d)
  Interventions:

  • Drug: esomeprazole
  • Drug: tripotassium dicitrate bismuthate
  • Drug: metronidazole
  • Drug: tetracycline

• Publications *: Kim MS, Kim N, Kim SE, Jo HJ, Shin CM, Park YS, Lee DH. Long-term follow up Helicobacter Pylori reinfection rate after second-line treatment: bismuth-containing quadruple therapy versus moxifloxacin-based triple therapy. BMC Gastroenterol. 2013 Sep 19;13:138. doi: 10.1186/1471-230X-13-138.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 14, 2013): 648
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients were considered persistent H. pylori infection if 13C-urea breath test (UBT) or invasive H. pylori test (Giemsa histology, CLO test, culture) were positive despite PPI-based triple therapy.

Exclusion Criteria:

• Patients were excluded from the study if they had a history of renal or hepatic impairment, previous gastric surgery, pregnancy or lactation, therapy with steroids or non-steroidal anti-inflammatory drugs, or therapy with a proton pump inhibitor (PPI) or antibiotics within four weeks of entry.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 23 Years to 84 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01792700
• Other Study ID Numbers: B-0603/031-013
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Nayoung Kim, Seoul National University Bundang Hospital
• Study Sponsor: Seoul National University Bundang Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Seoul National University Bundang Hospital
• Verification Date: February 2013