Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 81 of 215 for:    TETRACYCLINE

Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02159976
Recruitment Status : Completed
First Posted : June 10, 2014
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
SK Chemicals Co., Ltd.
Chong Kun Dang Pharmaceutical
CJ HealthCare Corporation
Green Cross Corporation
Information provided by (Responsible Party):
Nayoung Kim, Seoul National University Bundang Hospital

Brief Summary:
  1. To compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.
  2. To evaluate the effect of H. pylori eradication therapy on the symptom improvement of functional dyspepsia

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Pantoprazole Drug: Amoxicillin Drug: Clarithromycin Drug: Metronidazole Drug: Tetracycline Drug: Bismuth Not Applicable

Detailed Description:

Emerging evidence shows that the eradication rate of proton pump inhibitor (PPI)-based triple therapy for the first-line treatment of Helicobacter pylori has decreased. The reason for the decrease in the efficacy of PPI-based triple therapy is mainly due to the increase in the resistance against clarithromycin. Sequential therapy seems to be more effective than the PPI-based triple therapy, however, the eradication rate of sequential therapy in Korea, which is mostly under 80%, is still not satisfactory. Modified bismuth quadruple therapy which replace metronidazole with amoxicillin (contained PPI, bismuth, tetracycline and amoxicillin) can be a promising regimen because the antibiotic resistance rate of tetracycline and amoxicillin are relatively low in Korea and amoxicillin is more easy to take in comparing with metronidazole. Therefore, the aim of this study is to compare 10-day sequential therapy and 14-day modified bismuth quadruple therapy and to establish more effective first-line regimen for the eradication of Helicobacter pylori in Korea.

In addition, previous studies reported that H. pylori infection also associated with functional dyspepsia (FD) and recommended H. pylori eradication in patients with FD. However, until now, there was no randomized prospective study in Korea, therefore the another aim of this study is to evaluate the effect of H. pylori eradication therapy on the symptom improvement of FD.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare 10-day Sequential Therapy and 14-day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea
Study Start Date : July 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Active Comparator: Sequential therapy
pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)
Drug: Pantoprazole
Pantoprazole 40mg bid

Drug: Amoxicillin
Amoxicillin 1000mg bid

Drug: Clarithromycin
Clarithromycin 500mg bid

Drug: Metronidazole
Metronidazole 500mg tid

Experimental: Modified bismuth quadruple therapy
pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)
Drug: Pantoprazole
Pantoprazole 40mg bid

Drug: Amoxicillin
Amoxicillin 1000mg bid

Drug: Tetracycline
Tetracycline 1000mg bid

Drug: Bismuth
Bismuth 600mg bid




Primary Outcome Measures :
  1. Counts of Participants With Successful H. Pylori Eradication [ Time Frame: 4 weeks after termination of eradication therapy, up to 6 weeks ]

Secondary Outcome Measures :
  1. Counts of Participants Whose Drug Compliance is More Than 85% [ Time Frame: 4 weeks after termination of eradication therapy, up to 6 weeks ]
  2. Counts of Participants With Adverse Event [ Time Frame: 4 weeks after termination of eradication therapy, up to 6 weeks ]
  3. Functional Dyspepsia Symptom Responses Rate [ Time Frame: 1 year after termination 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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female Korean Adult (Aged ≥ 18 years)
  • Patients who diagnosis of H. pylori infection by any of following three methods

    • positive rapid urease test (CLOtest)
    • histologic evidence of H. pylori by modified Giemsa staining
    • positive 13C-urea breath test

Exclusion Criteria:

  • Age under 18 years
  • Previous eradication treatment for H. pylori
  • Patients who took any drug which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics
  • History of gastrectomy
  • Advanced gastric cancer or other malignancy
  • Abnormal liver function or liver cirrhosis
  • Abnormal renal function or chronic kidney disease
  • Other severe concurrent diseases
  • Previous allergic reactions to the study drugs
  • Pregnant or lactating women

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): NCT02159976


Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
SK Chemicals Co., Ltd.
Chong Kun Dang Pharmaceutical
CJ HealthCare Corporation
Green Cross Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nayoung Kim, Professor, M.D, Ph.D., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02159976     History of Changes
Other Study ID Numbers: B-1403/243-003
First Posted: June 10, 2014    Key Record Dates
Results First Posted: May 13, 2019
Last Update Posted: May 13, 2019
Last Verified: February 2019
Keywords provided by Nayoung Kim, Seoul National University Bundang Hospital:
Helicobacter pylori
Additional relevant MeSH terms:
Layout table for MeSH terms
Tetracycline
Amoxicillin
Metronidazole
Clarithromycin
Pantoprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Antacids