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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02090738
Other study ID # 4-2013-0941
Secondary ID
Status Withdrawn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Status Withdrawn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. completion date
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


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
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