Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 63 of 150 for:    tetracycline

Sequential Versus Quadruple Therapy in the Second-line Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208426
Recruitment Status : Recruiting
First Posted : July 5, 2017
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Esomeprazole (S14) Drug: Esomeprazole (BQ10) Drug: Amoxicillin (ST14) Drug: Clarithromycin (ST14) Drug: Metronidazole (ST14) Drug: dibismuth trioxide 120mg (BQ10) Drug: Metronidazole (BQ10) Drug: tetracycline (BQ10) Phase 4

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The technicians who performed the UBT test are blind to the treatment allocation
Primary Purpose: 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
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Sequential therapy for 14 days
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
Drug: Esomeprazole (S14)
Nexium, esomeprazole 40mg bid, 14 days
Other Name: Nexium

Drug: Amoxicillin (ST14)
Day 1-7 amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid for 7 days
Other Name: amoxicillin capsule

Drug: Clarithromycin (ST14)
Klaricid-XL, clarithromycin, 500mg, bid, for 7 days, (day 8-14)
Other Name: Klaricid-XL 500mg

Drug: Metronidazole (ST14)
Flagyl, metronidazole, 500mg bid, for 7 days (day 8-14)
Other Name: Flagyl

Active Comparator: bismuth quadruple therapy for 10 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
Drug: Esomeprazole (BQ10)
Nexium, esomeprazole, 40mg bid for 10 days
Other Name: Nexium (BQ10)

Drug: dibismuth trioxide 120mg (BQ10)
KCB F.C. TABLETS, dibismuth trioxide 120mg qid for 10 days
Other Name: KCB F.C. TABLETS

Drug: Metronidazole (BQ10)
Flagyl, metronidazole 500mg tid for 10 days
Other Name: Flagyl

Drug: tetracycline (BQ10)
Tetracycline (Brand name: Tetracycline Capsule ) 500mg qid for 10 days
Other Name: Tetracycline Capsule




Primary Outcome Measures :
  1. eradication rate in the second-line treatment according to intention to treat (ITT) analysis [ Time Frame: 6 weeks ]
    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 :
  1. Incidence of adverse effects in the first line therapy in the two treatment groups [ Time Frame: 2 weeks ]
    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

  2. Eradication rates in the second line treatment according to per protocol (PP) analysis [ Time Frame: 6 weeks ]
    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.

  3. Changes of gut microbiota in the two treatment groups [ Time Frame: 2 weeks, 8 weeks, and 1 year ]
    the stool specimens before, 2weeks after, 8 weeks after, and 1 year after the treatment will be collected for gut microbiota analysis

  4. Re-infection rate one year after eradication therapy [ Time Frame: 1 year ]
    Urea breath test will be performed 1 year after the end of eradication therapy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208426


Contacts
Layout table for location contacts
Contact: Jyh-Ming Liou, MD, PhD 886-2-23123456 ext 63541 jyhmingliou@gmail.com
Contact: Ming-Shiang Wu, MD, PhD 886-2-23123456 ext 65043 mingshiang@ntu.edu.tw

Locations
Layout table for location information
Taiwan
Jyh-Ming Liou Recruiting
Taipei, Taiwan, Taiwan, 10002
Contact: Jyh-Ming Liou       jyhmingliou@gmail.com   
Principal Investigator: Ming-Shiang Wu         
Principal Investigator: Yu-Jen Fang         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Layout table for investigator information
Study Chair: Jyh-Ming Liou, MD, PhD National Taiwan University Hospital
Principal Investigator: Yu-Jen Fang, MD National Taiwan University Hospital, Yun-Lin Branch

Publications of Results:
Layout table for additonal information
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03208426     History of Changes
Other Study ID Numbers: 201611053MINA
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Taiwan University Hospital:
Efficacy, Self
Additional relevant MeSH terms:
Layout table for MeSH terms
Tetracycline
Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Metronidazole
Clarithromycin
Esomeprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antacids