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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Brief Summary

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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 H. pylori eradication.

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Detailed Description

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Conditions

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H. Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm1

Treatment group

Group Type EXPERIMENTAL

Acetazolamide group

Intervention Type DRUG

Arm2

Control group

Group Type ACTIVE_COMPARATOR

Standard regimen group

Intervention Type DRUG

Interventions

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Acetazolamide group

Intervention Type DRUG

Standard regimen group

Intervention Type DRUG

Other Intervention Names

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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 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

Eligibility Criteria

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Inclusion Criteria

1. Age, between 19 and 70
2. H. 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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No