H. Pylori InfectionPhase 2NCT02090738
A Randomized, Open-label Study on Helicobacter Pylori Eradication With Standard Triple Regimen Plus Acetazolamide
A Phase 2 study testing Acetazolamide group and Standard regimen group in people with H. Pylori Infection, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- Acetazolamide group and Standard regimen group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age, between 19 and 70
- H. pylori infected patients
Who cannot join
- 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
Show all 12Show fewer
- Pregnancy or breast milk feeding
- Active infection
- Severe hepatic dysfunction
- Severe renal dysfunction
- Severe bone marrow dysfunction
- Significant neurologic or psychologic disease
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Acetazolamide group, Standard regimen group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetazolamide groupDrug
Also called 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
Standard regimen groupDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | Treatment group Receives: Drug: Acetazolamide group |
| Arm2 | Active comparator | Control group Receives: Drug: Standard regimen group |
What is being measured
The primary outcome is the main question the study is designed to answer.
H. pylori eradication rate
- pylori eradication rate will be assessed by urea breath test after eradication therapy.
Measured: 1 month from the eradication therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H. Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090738
- Sponsor's protocol ID
- 4-2013-0941
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study on Helicobacter Pylori Eradication With Standard Triple Regimen Plus Acetazolamide
- ClinicalTrials.gov ID
- NCT02090738
- Acronym / sponsor ID
- 4-2013-0941
- Conditions
- H. Pylori Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (estimated)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: Acetazolamide groupTreatment group |
| Arm2 | Active comparator | Drug: Standard regimen groupControl group |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age, between 19 and 70
- H. pylori infected patients
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetazolamide groupAlso: 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 | Drug | Arm1 |
| Standard regimen groupAlso: 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 | Drug | Arm2 |
Primary outcome
H. pylori eradication rate
Time frame: 1 month from the eradication therapy
H. pylori eradication rate will be assessed by urea breath test after eradication therapy.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
Related trials for H. Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Not yet recruitingPhase 2
Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
Helicobacter Pylori Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetazolamide group and Standard regimen group in people with H. Pylori Infection, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
H. pylori eradication rate (time frame: 1 month from the eradication therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2014.