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

H. Pylori Infection Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02090738
• Other study ID #: 4-2013-0941
• Status: Withdrawn
• Phase: Phase 2
• First received: March 14, 2014
• Last updated: April 27, 2014
• Start date: March 2014

Study information

• Verified date: March 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• H. Pylori Infection
• Helicobacter Infections

Intervention

Drug:
• Acetazolamide group

• Standard regimen group

Locations

Country	Name	City	State
Korea, Republic of	severnace Hospital	Seoul	Seodaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H. pylori eradication rate	H. pylori eradication rate will be assessed by urea breath test after eradication therapy.	1 month from the eradication therapy	Yes