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A Randomized, Open-label Study on Helicobacter Pylori Eradication With Standard Triple Regimen Plus Acetazolamide

Sponsor
Yonsei University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02090738
Collaborator
(none)
0
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

Helicobacter pylori infection is associated with several gastric diseases, including gastritis, peptic and duodenal ulcers, gastric carcinoma and MALToma. In 1994, the WHO classified the organism as a type 1 carcinogen. In order to eradicate H. pylori, at least two antibiotics and a proton pump inhibitor are used as a standard therapy regimen. Emerging antibiotic resistance to metronidazole or clarithromycin, however, has made successful treatment of infection progressively more difficult, with the success rate of standard triple therapy now at 70%, well below the 80% required for treatment of infectious diseases. Therefore, new treatment regimen is required for successful H. pylori eradication.

On the other hands, many in vitro studies revealed that bacterial carbonic anhydrase in H. pylori has an important role for surviving of H. pylori in the stomach. It was demonstrated that mutation of carbonic anhydrase affected survival of H. pylori. The investigators therefore expected that administration of carbonic anhydrase inhibitor (acetazolamide) with standard H. pylori eradication regimen would increase the eradication rate. Here, the investigators aim to evaluate the efficacy of standard triple regimen plus acetazolamide for

  1. pylori eradication.
Condition or Disease Intervention/Treatment Phase
  • Drug: Acetazolamide group
  • Drug: Standard regimen group
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm1

Treatment group

Drug: Acetazolamide group
Other Names:
  • Esomeprazole (Nexium®, AstraZeneca Korea, Co. Ltd., Seoul, Korea) 40 mg, bid, for 7 days
  • Amoxicillin (Kymoxin®, Yuhan Co. Ltd., Seoul, Korea) 1 g, bid, for 7 days
  • Clarithromycin (Klaricid®, Abbot Korea Co. Ltd., Seoul, Korea) 500 mg, bid, for 7 days
  • Acetazolamide (Diamox®, SK Chemicals Co. Ltd., Suwon, Korea) 250mg, bid, for 7 days

    		•
    Active Comparator: Arm2

    Control group

    Drug: Standard regimen group
    Other Names:
  • Esomeprazole (Nexium®, AstraZeneca Korea, Co. Ltd., Seoul, Korea) 40 mg, bid, for 7 days
  • Amoxicillin (Kymoxin®, Yuhan Co. Ltd., Seoul, Korea) 1 g, bid, for 7 days
  • Clarithromycin (Klaricid®, Abbot Korea Co. Ltd., Seoul, Korea) 500 mg, bid, for 7 days

    		•

    Outcome Measures

    Primary Outcome Measures

    1. H. pylori eradication rate [1 month from the eradication therapy]

      H. pylori eradication rate will be assessed by urea breath test after eradication therapy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age, between 19 and 70

      1. pylori infected patients
    Exclusion Criteria:

    1. Previous history of H. pylori eradication

    2. Previous history of gastrectomy

    3. Administration of PPI, H2 blocker, antibiotics, or bismuth within 1 month prior to enrollment

    4. Allergy to sulfonamide

    5. Electrolyte imbalance

    6. Adrenal insufficiency

    7. Pregnancy or breast milk feeding

    8. Active infection

    9. Severe hepatic dysfunction

    10. Severe renal dysfunction

    11. Severe bone marrow dysfunction

    12. Significant neurologic or psychologic disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 severnace Hospital Seoul Seodaemun-gu Korea, Republic of 120-752

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT02090738
    Other Study ID Numbers:
    • 4-2013-0941
    First Posted:
    Mar 18, 2014
    Last Update Posted:
    Apr 29, 2014
    Last Verified:
    Mar 1, 2014
    Additional relevant MeSH terms:
    Amoxicillin
    Clarithromycin
    Acetazolamide
    Esomeprazole

    Study Results

    No Results Posted as of Apr 29, 2014