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High Dose Dual Therapy (HDDT) for Eradication of Helicobacter Pylori Infection (HDDT)

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ClinicalTrials.gov Identifier: NCT02553083
Recruitment Status : Recruiting
First Posted : September 17, 2015
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Yaron Niv, Rabin Medical Center

Brief Summary:

The investigators will performed a large-scale multi center trial to compare the efficacy of a high-dose dual therapy (HDDT) with that of standard therapies in treatment-naive (n = 300) patients with Hp infection. Consecutive symptomatic patients will be recruited in Israel and Spain when tested positive to Hp with serology and 13C urea breath test (13C-UBT) due to symptoms. Patients with gastric cancer, MALT lymphoma, and younger than 18 or older than 80 years old will be excluded. All patients will be naive to eradication therapy and will be randomized into one of three groups:

Group 1: Nexium 40 mg and amoxicillin 1.5 gr twice daily for 14 days Group 2: Nexium 40 mg and doxycycline 200 mg twice a day Group 3: Triple therapy of Nexium 20 mg, clarythromycin 500 mg, and amoxicillin 1gr twice a day for 10 days (regular accepted treatment).

All treatments will be stopped for a month and then 13CUBT will be repeated. The primary aim of the study is to assess eradication success, intentioned to treat and per protocol in the three treatment regimens.

The secondary aim of the study is to assess the safety of high dose amoxicillin and doxycycline.


Condition or disease Intervention/treatment Phase
Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Drug: Nexium 40 mg Drug: amoxicillin 1.5 gr Drug: doxycycline 200 mg Drug: Nexium 20 mg Drug: clarythromicin 500 mg Drug: amoxicillin 1gr Phase 4

Detailed Description:

Introduction High dose dual therapy (HDDT) for Helicobacter pylori (Hp) eradication was successfully tried in Taiwan for naive as well as experienced patients who failed a previous trial. This new approach relies on the rare resistance of Hp to amoxicillin which is about 1% all over the world. High intra gastric pH increases the efficacy of amoxicillin, thus the "old" dual therapy with a proton pump inhibitor and amoxicillin, but now in high doses for a longer time, has a potential to achieve a high eradication rate. Yang and co investigators randomized 450 naïve and 168 treatment-experienced patients in Taiwan, all infected by Hp, for HDDT, sequential and triple therapies. In the intention-to-treat analysis, Hp was eradicated in 95.3%, 85.3% and 80.7%, respectively in naïve, and 89.3%, 51.8% and 78.6%, respectively in experienced patients. No more adverse events were found in the HDDT group. They divided the high dose of amoxicillin into 4 doses a day. This approach may be unnecessary since Kim and colleagues demonstrated the same results when the same dose of amoxicillin was divided into 2 or 4 times a day. Recently doxcycylin was found effective in triple or quadruple therapy regimens with no adverse effect in the high dose of 200 mg BID.

The investigators will try that approach, successful in Asian patients, in a collaborative study that included Spanish and Israeli patients. The investigators will investigate whether a combination of a high-dose proton pump inhibitor and amoxicillin (dual therapy) will be more effective than standard first-line 10 days triple therapy in eradicating Hp. Since patients who are allergic to penicillin cannot be treated with amoxicillin The investigators will compare HDDT amoxicillin-based therapy also with HDDT doxycycline -based therapy.

Protocol

The investigators will performed a large-scale multi center trial to compare the efficacy of a high-dose dual therapy (HDDT) with that of standard therapies in treatment-naive (n = 300) patients with Hp infection. Consecutive symptomatic patients will be recruited in Israel and Spain when tested positive to Hp with serology and 13CUBT due to symptoms. Patients with gastric cancer, MALT lymphoma, and younger than 18 or older than 80 years old will be excluded. All patients will be naive to eradication therapy and will be randomized into one of three groups:

Group 1: Nexium 40 mg and amoxicillin 1.5 gr twice daily for 14 days Group 2: Nexium 40 mg and doxycycline 200 mg twice a day Group 3: Triple therapy of Nexium 20 mg, clarythromycin 500 mg, and amoxicillin 1gr twice a day for 10 days (regular accepted treatment).

All treatments will be stopped for a month and then 13CUBT will be repeated. The primary aim of the study is to assess eradication success, intentioned to treat and per protocol in the three treatment regimens.

The secondary aim of the study is to assess the safety of high dose amoxicillin and doxycycline .

Hypothesis The investigators hypothesize that the success rate of eradication therapy in groups 1 and 2 will be significantly better than of group 3, with a good safety profile. If so, HDDT will be the answer for Hp eradication in areas with high Clarithromycin and metronidazole resistance.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Dual Therapy (HDDT) for Eradication of Helicobacter Pylori Infection
Actual Study Start Date : October 22, 2015
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
Nexium 40 mg and amoxicillin 1.5 gr twice daily for 14 days
Drug: Nexium 40 mg
Nexium 40 mg twice daily for 14 days

Drug: amoxicillin 1.5 gr
amoxicillin 1.5 gr twice daily for 14 days

Active Comparator: Group 2
Nexium 40 mg and doxycycline 200 mg twice daily for 14 days
Drug: Nexium 40 mg
Nexium 40 mg twice daily for 14 days

Drug: doxycycline 200 mg
doxycycline 200 mg twice daily for 14 days

Active Comparator: Group 3
Nexium 20 mg, clarythromicin 500 mg, and amoxicillin 1 gr twice daily for 14 days
Drug: Nexium 20 mg
Nexium 20 mg twice a day for 10 days

Drug: clarythromicin 500 mg
clarythromicin 500 mg twice a day for 10 days

Drug: amoxicillin 1gr
amoxicillin 1gr twice a day for 10 days




Primary Outcome Measures :
  1. Eradication rate [ Time Frame: 2 weeks therapy ]
    Eradication rate



Information from the National Library of Medicine

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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:

  • Patients infected with Helicobacter pylori

Exclusion Criteria:

  • Patients with gastric cancer or MALT lymphoma

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): NCT02553083


Contacts
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Contact: Yaron Niv, MD 972504065401 yniv@clalit.org.il

Locations
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Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel, 49100
Contact: Yaron Niv, MD    97239377237    yniv@clalit.org.il   
Principal Investigator: Yaron Niv, MD         
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Yaron Niv, MD RMC

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Responsible Party: Yaron Niv, Chief of Gastroenterology, Deputy CEO RMC, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02553083     History of Changes
Other Study ID Numbers: 0380-15-RMC
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Helicobacter Infections
Gram-Negative Bacterial Infections
Amoxicillin
Doxycycline
Esomeprazole
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action