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Trial record 4 of 22 for:    "Bacterial Infectious Disease" | "Guaifenesin"

Dexlansoprazole MR-Based Concomitant Quadruple Therapy

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ClinicalTrials.gov Identifier: NCT03829150
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Seng-Kee Chuah, Chang Gung Memorial Hospital

Brief Summary:

Background:

Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently because the increasing incidence of clarithromycin-resistant strains of H. pylori. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising success rate of >90 % in the presence of clarithromycin resistance. However, high dose PPI is needed with a dosage of twice daily but when a dual delayed release formulation PPI in capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production. Thus, it improves acid suppression and offer benefits over conventional single release PPI formulations. by prolonging optimal plasma concentration and create a favorable condition H. pylori eradication

Aim:

The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy


Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Dexlan Drug: Amoxicillin Drug: Clarithromycin 500mg Drug: Metronidazole Not Applicable

Detailed Description:

Background:

Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less) recently because the increasing incidence of clarithromycin-resistant strains of H. pylori. Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥ 20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising success rate of >90% in the presence of clarithromycin resistance. However, high dose PPI is needed with a dosage of twice daily but when a dual delayed release formulation PPI in capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via inhibition of the proton pump in the gastric parietal cell, which blocks the final step of acid production. Thus, it improves acid suppression and offer benefits over conventional single release PPI formulations. by prolonging optimal plasma concentration and create a favorable condition H. pylori eradication

Aim:

The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy

Methods:

Two hundred and two consecutive H. pylori-infected participants are randomly assigned to a 7-day Dexlansoprazole MR-based non-bismuth quadruple therapy (Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days) or a 7-day lansoprazole-based non-bismuth quadruple therapy (Lansoprazole 30 mg bid. , clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days). Participants are asked to return at the 2nd week to assess drug compliance and adverse events. Repeated endoscopy with rapid urease test, histological examination is performed at the 8th week after the end of anti- H. pylori therapy. If participants refuse follow-up endoscopy, urea breath tests are conducted to assess H. pylori status. The rates of eradication are analyzed by intention-to-treat and per-protocol analysis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-Helicobacter Pylori Therapy With Dexlansoprazole MR-Based Concomitant Quadruple Therapy- A Prospective Randomized Trial
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : April 20, 2019
Actual Study Completion Date : April 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexlansoprazole MR group
Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days
Drug: Dexlan
Dexlansoprazole MR 60 mg qd for 7 days
Other Name: Dexlansoprazole MR

Drug: Amoxicillin
Amoxicillin (Amolin) 1 g bid. for 7 days
Other Name: Amolin

Drug: Clarithromycin 500mg
clarithromycin (Klaricid) 500 mg bid for 7 days
Other Name: Klaricid

Drug: Metronidazole
Metronidazole (Flagyl) 500 mg bid daily for 7 days
Other Name: Flagyl

Experimental: lansoprazole group
Lansoprazole 30 mg bid., clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days
Drug: Dexlan
Dexlansoprazole MR 60 mg qd for 7 days
Other Name: Dexlansoprazole MR

Drug: Amoxicillin
Amoxicillin (Amolin) 1 g bid. for 7 days
Other Name: Amolin

Drug: Clarithromycin 500mg
clarithromycin (Klaricid) 500 mg bid for 7 days
Other Name: Klaricid

Drug: Metronidazole
Metronidazole (Flagyl) 500 mg bid daily for 7 days
Other Name: Flagyl




Primary Outcome Measures :
  1. The rates of H.pylori eradication [ Time Frame: 8 weeks ]
    The primary outcome variables were the rates of eradication. Chi-square test with or without Yates correction for continuity and Fisher's exact test were used when appropriate to compare the major outcomes between groups. A P value less than 0.05 was considered statistically significant.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

H. pylori-infected outpatients with endoscopically proven peptic ulcer diseases or gastritis.

Exclusion Criteria:

  1. Previous H. pylori-eradication therapy
  2. ingestion of antibiotics, bismuth, or PPIs 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): NCT03829150


Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital,Taiwan
Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Seng-Kee Chuah, MD Kaohsiung Chang Gung Memorial Hospital,Taiwan

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Responsible Party: Seng-Kee Chuah, Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03829150     History of Changes
Other Study ID Numbers: CMRPG8F1421
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seng-Kee Chuah, Chang Gung Memorial Hospital:
non-bismuth containing quadruple therapy

Additional relevant MeSH terms:
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Gram-Negative Bacterial Infections
Bacterial Infections
Helicobacter Infections
Amoxicillin
Metronidazole
Clarithromycin
Lansoprazole
Dexlansoprazole
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