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

NCT02090738 | Withdrawn Phase 2 DMC

• 1 other identifier: 4-2013-0941
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 H. pylori eradication.

Conditions

H. Pylori Infection

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate

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

  1 month from the eradication therapy

Study Arms (2)

Arm1

EXPERIMENTAL

Treatment group

Drug: Acetazolamide group

Arm2

ACTIVE COMPARATOR

Control group

Drug: Standard regimen group

Interventions

Acetazolamide group DRUG

Also known as: 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

Arm1

Standard regimen group DRUG

Also known as: 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

Arm2

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age, between 19 and 70
• H. pylori infected patients

You may not qualify if:

• Previous history of H. pylori eradication
• Previous history of gastrectomy
• Administration of PPI, H2 blocker, antibiotics, or bismuth within 1 month prior to enrollment
• Allergy to sulfonamide
• Electrolyte imbalance
• Adrenal insufficiency
• Pregnancy or breast milk feeding
• Active infection
• Severe hepatic dysfunction
• Severe renal dysfunction
• Severe bone marrow dysfunction
• Significant neurologic or psychologic disease

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

severnace Hospital

Seoul, Seodaemun-gu, 120-752, South Korea

Location

MeSH Terms

Interventions

Esomeprazole; BID protein, human; WW Domain-Containing Oxidoreductase; Amoxicillin; Clarithromycin; Acetazolamide

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones; Thiadiazoles; Thiazoles; Azoles

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 18, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Last Updated: April 29, 2014

Record last verified: 2014-03

Locations

KR (1)