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

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.

Study Overview

• Status: Withdrawn
• Conditions: H. Pylori Infection
• Intervention / Treatment: Drug: Acetazolamide group; Drug: Standard regimen group

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, Korea, Republic of, 120-752
      • severnace Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
H. pylori eradication rate	H. pylori eradication rate will be assessed by urea breath test after eradication therapy.	1 month from the eradication therapy

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: March 14, 2014
• First Submitted That Met QC Criteria: March 17, 2014
• First Posted (Estimate): March 18, 2014

Study Record Updates

• Last Update Posted (Estimate): April 29, 2014
• Last Update Submitted That Met QC Criteria: April 27, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Anti-Bacterial Agents; Diuretics; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Anticonvulsants; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Acetazolamide; Amoxicillin; Clarithromycin; Esomeprazole
• Other Study ID Numbers: 4-2013-0941