Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 62 of 215 for:    TETRACYCLINE

Comparison of Hybrid and Bismuth Quadruple Therapies for Helicobacter Pylori Eradication

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: NCT02541864
Recruitment Status : Completed
First Posted : September 4, 2015
Results First Posted : August 10, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Feng-Woei Tsay, Kaohsiung Veterans General Hospital.

Brief Summary:
According the Maastricht IV consensus report publish in the Gut 2012, bismuth containing quadruple therapy was suggested to be the first choice for eradication therapy of Helicobacter pylori in the area with high clarithromycin resistance. Whether hybrid therapy or 14-day bismuth containing quadruple therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 14-day hybrid therapy and 14-day bismuth containing quadruple therapy in first-line treatment.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Bismuth quadruple therapy Drug: Hybrid therapy Not Applicable

Detailed Description:
For this randomly assigned to receive either a 14-day hybrid therapy (a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days) or a 14-day bismuth containing quadruple therapies (pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days).at a 1:1 ratio. Our primary outcomes was the eradication rate by intention-to-treat and per- protocol analyses

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Hybrid and Bismuth Containing Quadruple Therapies for Helicobacter Pylori Eradication: a Randomized Controlled Trial
Study Start Date : July 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: Bismuth quadruple therapy
pantoprazole 40 mg bid for 14 days, bismuth subcitrate 120 mg qid for 14 days, tetracycline 500 mg qid for 14 days, metronidazole 250 mg qid for 14 days
Drug: Bismuth quadruple therapy
pantoprazole 40 mg bid for 14 days, bismuth subcitrate 120 mg qid for 14 days, tetracycline 500 mg qid for 14 days, metronidazole 250 mg qid for 14 days
Other Names:
  • pantoprazole
  • bismuth subcitrate
  • tetracycline
  • metronidazole

Active Comparator: Hybrid therapy
(pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days) followed by (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days, clarithromycin 500 mg bid for 7 days, and metronidazole 500 mg bid for 7 days)
Drug: Hybrid therapy
(pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days) followed by (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days, clarithromycin 500 mg bid for 7 days, and metronidazole 500 mg bid for 7 days)
Other Names:
  • pantoprazole
  • amoxicillin
  • clarithromycin
  • metronidazole




Primary Outcome Measures :
  1. Number of Participants in Which H. Pylori Was Eradicated [ Time Frame: at the 6th week after the end of anti- H. pylori therapy ]
    Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status.



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:   No
Criteria

Inclusion Criteria:

  • Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

  • previous H pylori-eradication therapy
  • ingestion of antibiotics or bismuth within the prior 4 weeks
  • patients with allergic history to the medications used
  • patients with previous gastric surgery
  • the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
  • pregnant 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): NCT02541864


Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
Layout table for investigator information
Study Chair: Ping-I Hsu, Bachelor Kaohsiung Veterans General Hospital.

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Feng-Woei Tsay, ASSISTANT PROFESSOR, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02541864     History of Changes
Other Study ID Numbers: VGHKS12-CT11-08
First Posted: September 4, 2015    Key Record Dates
Results First Posted: August 10, 2017
Last Update Posted: November 24, 2017
Last Verified: September 2015
Keywords provided by Feng-Woei Tsay, Kaohsiung Veterans General Hospital.:
Helicobacter pylori
Hybrid therapy
Bismuth containing quadruple therapy
Eradication
Additional relevant MeSH terms:
Layout table for MeSH terms
Tetracycline
Amoxicillin
Metronidazole
Clarithromycin
Bismuth tripotassium dicitrate
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