Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 38 for:    "Bacterial Infectious Disease" | "Rabeprazole"

Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection

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: NCT02541786
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
DENG-CHYANG WU, Kaohsiung Medical University

Brief Summary:
Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a dual delayed release formulation. It is effective for symptom control of patients with gastroesophageal reflux disease. However, its efficacy in the treatment of H.pylori infection remains unclear. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H.pylori infection.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: dexlansoprazole based triple therapy Drug: rabeprazole-based triple therapy Phase 4

Detailed Description:
Helicobacter pylori (H.pylori) infect more than 50% of humans globally. It is the major cause of chronic gastritis, gastric ulcer, duodenal ulcer, gastric adenocarcinoma and gastric mucosa-associated lymphoid tissue lymphoma (MALToma). H.pylori eradication has become the standard and most widely adopted therapy to cure peptic ulcer disease. This therapy is also strongly recommended in the treatment of H pylori-related MALToma. In regions with high incidence of gastric adenocarcinoma, eradication of H pylori is advocated as a preventative measure. Proton pump inhibitor (PPI) is one of the key medicines in anti-H pylori regimens. It possesses anti-H pylori activity, and, by reducing gastric acid secretion, it also increases bioavailability and activity of some antibiotics. This study was conducted to investigate whether the efficacy of single-dose dexlansoprazole MR-based triple therapy was non-inferior to double-dose rabeprazole-based triple therapy in the treatment of H pylori infection.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Dexlansoprazole-based Triple and Rabeprazole-based Triple Therapies for Helicobacter Pylori Infection
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: dexlansoprazole based triple therapy
dexlansoprazole MR 60 mg once daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Drug: dexlansoprazole based triple therapy
dexlansoprazole MR 60 mg once daily+clarithromycin 500 mg twice daily+ amoxicillin 1 g twice daily for 7 days
Other Name: Dexilant-based triple therapy

Experimental: rabeprazole-based triple therapy
rabeprazole 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
Drug: rabeprazole-based triple therapy
rabeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + amoxicillin 1 g twice daily for 7 days
Other Name: Pariet-based triple therapy




Primary Outcome Measures :
  1. The rate of H.pylori eradication [ Time Frame: 6 weeks after finishing study drugs ]
    Evaluate eradication outcome by 13C urea breath test


Secondary Outcome Measures :
  1. Drug Compliance [ Time Frame: 6 weeks after finishing study drugs ]
    Good drug compliance measured by number of subjects taking >= 80% eradication medicines



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:

  1. Male or non-pregnant female aged more than 20 years.
  2. H. pylori-infected outpatients
  3. Mental and legal ability to give a written informed consent.

Exclusion Criteria:

  1. previous H pylori-eradication therapy,
  2. ingestion of antibiotics or bismuth within the prior 4 weeks,
  3. patients with allergic history to the medications used,
  4. patients with previous gastric surgery,
  5. the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia),
  6. 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): NCT02541786


Locations
Layout table for location information
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Medical University
Investigators
Layout table for investigator information
Study Chair: DENG-CHYANG WU, MD, PHD Kaohsiung Medical University

Layout table for additonal information
Responsible Party: DENG-CHYANG WU, Clinical Professor, Kaohsiung Medical University
ClinicalTrials.gov Identifier: NCT02541786     History of Changes
Other Study ID Numbers: KaohsiungMUH
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015

Keywords provided by DENG-CHYANG WU, Kaohsiung Medical University:
dexlansoprazole MR
rabeprazole
Helicobacter pylori
triple therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Gram-Negative Bacterial Infections
Bacterial Infections
Rabeprazole
Infection
Communicable Diseases
Helicobacter Infections
Amoxicillin
Clarithromycin
Dexlansoprazole
Lansoprazole
Anti-Bacterial Agents
Anti-Infective 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