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Sequential Versus Quadruple Therapy in the Second-line Treatment

Primary Purpose

Helicobacter Pylori Infection

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Esomeprazole (S14)
Esomeprazole (BQ10)
Amoxicillin (ST14)
Clarithromycin (ST14)
Metronidazole (ST14)
dibismuth trioxide 120mg (BQ10)
Metronidazole (BQ10)
tetracycline (BQ10)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Efficacy, Self

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • H. pylori infected patients who fail from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor will be eligible in this study.

Exclusion Criteria:

Patients will be excluded from the study if any one of the following criteria was present:

  • children and teenagers aged less than 20 years,
  • history of gastrectomy,
  • gastric malignancy, including adenocarcinoma and lymphoma,
  • previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and PPI (esomeprazole),
  • contraindication to treatment drugs,
  • pregnant or lactating women,
  • severe concurrent disease, or
  • Unwilling to accept random assignment of subjects.

Sites / Locations

  • Jyh-Ming LiouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sequential therapy for 14 days

bismuth quadruple therapy for 10 days

Arm Description

Sequential therapy for 14 days (experimental) D1-D7: (Nexium, esomeprazole 40mg bid + amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid) for 7 days D8-D14: (Nexium, esomeprazole 40mg bid + Klaricid XL, clarithromycin 500mg bid + Flagyl, metronidazole 500mg bid) for another 7 days

Bismuth quadruple therapy for 10 days (active comparator) D1-D10: (Nexium, esomeprazole 40mg bid + KCB F.C. TABLETS, dibismuth trioxide 120mg qid + Flagyl, metronidazole 500mg tid + tetracycline (Brand name: Tetracycline Capsule ) 500mg qid) for 10 days

Outcomes

Primary Outcome Measures

eradication rate in the second-line treatment according to intention to treat (ITT) analysis
Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Successful eradication of H. pylori will be defined as a negative 13C-UBT result. A positive 13C-UBT test will be defined as a delta value of 4 units or greater. All subjects will be asked to stop PPI and H2-blocker for at least two weeks before 13C-UBT.

Secondary Outcome Measures

Incidence of adverse effects in the first line therapy in the two treatment groups
At enrollment, the patients will be informed of the common side effects from the studied drugs and they will be asked to record these symptoms during treatment. A standardized interview and questionnaire will be used to assess the adverse events
Eradication rates in the second line treatment according to per protocol (PP) analysis
Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Patients not follow the protocol will be excluded for PP analysis.
Changes of gut microbiota in the two treatment groups
the stool specimens before, 2weeks after, 8 weeks after, and 1 year after the treatment will be collected for gut microbiota analysis
Re-infection rate one year after eradication therapy
Urea breath test will be performed 1 year after the end of eradication therapy.

Full Information

First Posted
May 21, 2017
Last Updated
June 1, 2018
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03208426
Brief Title
Sequential Versus Quadruple Therapy in the Second-line Treatment
Official Title
Comparison of the Efficacy of 14-day Sequential Therapy and 10-day Bismuth Quadruple Therapy in the Second Line Therapy for Helicobacter Pylori Infection: A Multi-center Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objectives: A recent randomized trial showed that 14-day sequential therapy containing high dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains unknown. Therefore, the investigators aimed to compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the second line treatment.
Detailed Description
This will be a multi-center, open labeled, randomized comparative trial Patients: 240 patients with H. pylori infection who failed after first-line therapy will be eligible Interventions: eligible patients will be randomized into one of the two groups Group (A): sequential therapy for 14 days (S14) D1-D7: (esomeprazole 40mg bid + amoxicillin 1000mg bid) for 7 days D8-D14: (esomeprazole 40mg bid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days Group (B): bismuth quadruple therapy for 10 days (Q10) D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days Primary End Point: Eradication rate in the second line treatment according to intention to treat (ITT) analysis in the two treatment groups

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Efficacy, Self

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The technicians who performed the UBT test are blind to the treatment allocation
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sequential therapy for 14 days
Arm Type
Experimental
Arm Description
Sequential therapy for 14 days (experimental) D1-D7: (Nexium, esomeprazole 40mg bid + amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid) for 7 days D8-D14: (Nexium, esomeprazole 40mg bid + Klaricid XL, clarithromycin 500mg bid + Flagyl, metronidazole 500mg bid) for another 7 days
Arm Title
bismuth quadruple therapy for 10 days
Arm Type
Active Comparator
Arm Description
Bismuth quadruple therapy for 10 days (active comparator) D1-D10: (Nexium, esomeprazole 40mg bid + KCB F.C. TABLETS, dibismuth trioxide 120mg qid + Flagyl, metronidazole 500mg tid + tetracycline (Brand name: Tetracycline Capsule ) 500mg qid) for 10 days
Intervention Type
Drug
Intervention Name(s)
Esomeprazole (S14)
Other Intervention Name(s)
Nexium
Intervention Description
Nexium, esomeprazole 40mg bid, 14 days
Intervention Type
Drug
Intervention Name(s)
Esomeprazole (BQ10)
Other Intervention Name(s)
Nexium (BQ10)
Intervention Description
Nexium, esomeprazole, 40mg bid for 10 days
Intervention Type
Drug
Intervention Name(s)
Amoxicillin (ST14)
Other Intervention Name(s)
amoxicillin capsule
Intervention Description
Day 1-7 amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid for 7 days
Intervention Type
Drug
Intervention Name(s)
Clarithromycin (ST14)
Other Intervention Name(s)
Klaricid-XL 500mg
Intervention Description
Klaricid-XL, clarithromycin, 500mg, bid, for 7 days, (day 8-14)
Intervention Type
Drug
Intervention Name(s)
Metronidazole (ST14)
Other Intervention Name(s)
Flagyl
Intervention Description
Flagyl, metronidazole, 500mg bid, for 7 days (day 8-14)
Intervention Type
Drug
Intervention Name(s)
dibismuth trioxide 120mg (BQ10)
Other Intervention Name(s)
KCB F.C. TABLETS
Intervention Description
KCB F.C. TABLETS, dibismuth trioxide 120mg qid for 10 days
Intervention Type
Drug
Intervention Name(s)
Metronidazole (BQ10)
Other Intervention Name(s)
Flagyl
Intervention Description
Flagyl, metronidazole 500mg tid for 10 days
Intervention Type
Drug
Intervention Name(s)
tetracycline (BQ10)
Other Intervention Name(s)
Tetracycline Capsule
Intervention Description
Tetracycline (Brand name: Tetracycline Capsule ) 500mg qid for 10 days
Primary Outcome Measure Information:
Title
eradication rate in the second-line treatment according to intention to treat (ITT) analysis
Description
Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Successful eradication of H. pylori will be defined as a negative 13C-UBT result. A positive 13C-UBT test will be defined as a delta value of 4 units or greater. All subjects will be asked to stop PPI and H2-blocker for at least two weeks before 13C-UBT.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse effects in the first line therapy in the two treatment groups
Description
At enrollment, the patients will be informed of the common side effects from the studied drugs and they will be asked to record these symptoms during treatment. A standardized interview and questionnaire will be used to assess the adverse events
Time Frame
2 weeks
Title
Eradication rates in the second line treatment according to per protocol (PP) analysis
Description
Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Patients not follow the protocol will be excluded for PP analysis.
Time Frame
6 weeks
Title
Changes of gut microbiota in the two treatment groups
Description
the stool specimens before, 2weeks after, 8 weeks after, and 1 year after the treatment will be collected for gut microbiota analysis
Time Frame
2 weeks, 8 weeks, and 1 year
Title
Re-infection rate one year after eradication therapy
Description
Urea breath test will be performed 1 year after the end of eradication therapy.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: H. pylori infected patients who fail from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor will be eligible in this study. Exclusion Criteria: Patients will be excluded from the study if any one of the following criteria was present: children and teenagers aged less than 20 years, history of gastrectomy, gastric malignancy, including adenocarcinoma and lymphoma, previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and PPI (esomeprazole), contraindication to treatment drugs, pregnant or lactating women, severe concurrent disease, or Unwilling to accept random assignment of subjects.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jyh-Ming Liou, MD, PhD
Phone
886-2-23123456
Ext
63541
Email
jyhmingliou@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ming-Shiang Wu, MD, PhD
Phone
886-2-23123456
Ext
65043
Email
mingshiang@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jyh-Ming Liou, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yu-Jen Fang, MD
Organizational Affiliation
National Taiwan University Hospital, Yun-Lin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jyh-Ming Liou
City
Taipei, Taiwan
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyh-Ming Liou
Email
jyhmingliou@gmail.com
First Name & Middle Initial & Last Name & Degree
Ming-Shiang Wu
First Name & Middle Initial & Last Name & Degree
Yu-Jen Fang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27769562
Citation
Liou JM, Fang YJ, Chen CC, Bair MJ, Chang CY, Lee YC, Chen MJ, Chen CC, Tseng CH, Hsu YC, Lee JY, Yang TH, Luo JC, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hu WH, Chen YN, Sheu BS, Lin JT, Wu JY, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Concomitant, bismuth quadruple, and 14-day triple therapy in the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2016 Nov 12;388(10058):2355-2365. doi: 10.1016/S0140-6736(16)31409-X. Epub 2016 Oct 18.
Results Reference
result
PubMed Identifier
23158886
Citation
Liou JM, Chen CC, Chen MJ, Chen CC, Chang CY, Fang YJ, Lee JY, Hsu SJ, Luo JC, Chang WH, Hsu YC, Tseng CH, Tseng PH, Wang HP, Yang UC, Shun CT, Lin JT, Lee YC, Wu MS; Taiwan Helicobacter Consortium. Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2013 Jan 19;381(9862):205-13. doi: 10.1016/S0140-6736(12)61579-7. Epub 2012 Nov 16. Erratum In: Lancet. 2013 Apr 13;381(9874):1276.
Results Reference
result

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Sequential Versus Quadruple Therapy in the Second-line Treatment

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