Peptic UlcerPhase 4NCT01453036

Clarithromycin Resistant Tailored Therapy

A Phase 4 study testing 23S rRNA point mutation test of Helicobacter pylori and UBT test & Gastroenterology with biopsy c silver stain in people with Peptic Ulcer and Helicobacter Pylori Infection, run by Jin Il Kim at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23S rRNA point mutation of Helicobacter pylori is associated clarithromycin resistance 2. Read more about this study

Who is it for?: Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Peptic Ulcer, Helicobacter Pylori Infection
What is being tested?: 23S rRNA point mutation test of Helicobacter pylori and UBT test & Gastroenterology with biopsy c silver stain
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 924 participants
Where: 1 siteSouth Korea
Study dates: Aug 2011to Jun 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

20 - 75 years old
Peptic ulcer (gastric ulcer, duodenal ulcer)
Helicobacter pylori positive

Who cannot join

Major comorbidities
Pregnancy
History of Helicobacter pylori eradication
History of gastric surgery or other cancers, except to endoscopic treatment due to gastric lesion

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Gastroenterology Clinic
Seoul, Yeouido-dong/Yeongdeungpo-gu, 150-713

Other trials in South Korea

About this study

Official title: Eradication of Helicobacter Pylori According to 23S rRNA Point Mutations Associated With Clarithromycin Resistance

Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23S rRNA point mutation of Helicobacter pylori is associated clarithromycin resistance
Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment regimens containing a proton pump inhibitor and combination of two antibiotics (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate Helicoabacter pylori more successfully
Material \& methods The investigators enroll patients diagnosed with peptic ulcer, endoscopically. Helicobacter pylori is documented with Urea breath test or silver staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation, the investigators consider as resistance to clarithromycin and choose the treatment regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin, clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare eradication rate with conventional treatment,proton pump inhibitor, amoxicillin, clarithromycin.

Conditions: Peptic Ulcer, Helicobacter Pylori Infection
Being tested: 23S rRNA point mutation test of Helicobacter pylori, UBT test & Gastroenterology with biopsy c silver stain
Keywords: Peptic ulcer, Helicobacter pylori, Clarithromycin, 23S rRNA, Resistance
Medical subject headings: Peptic Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

23S rRNA point mutation test of Helicobacter pyloriProcedure or surgery
Also called Seeplex ClaR-Helicobacter pylori polymerase chain reaction kit of Seegene Incorporated, Seoul, Korea
mutation test group>> Helicobacter pylori polymerase chain reaction kit by dual-priming oligonucleotide-based multiplex polymerase chain reaction system before eradication of Helicobacter pylori at mutation test groupConventional Conventional AOC group, Conventional AOM group >> no intervention
UBT test & Gastroenterology with biopsy c silver stainProcedure or surgery
UBT test \& Gastroenterology with biopsy c silver stain due to indentify H. pylori infection Conventional AOM group, Conventional AOC group, Mutation test group >> intervention

Study groups in NCT01453036
Study group	Role	What they receive
Conventional AOC group	Active comparator	The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks Receives: Procedure: UBT test & Gastroenterology with biopsy c silver stain
Mutation test group	Active comparator	Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Receives: Procedure: 23S rRNA point mutation test of Helicobacter pylori; Procedure: UBT test & Gastroenterology with biopsy c silver stain
Conventional AOM group	Active comparator	The investigators do not perform mutation test in the conventional group apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Receives: Procedure: UBT test & Gastroenterology with biopsy c silver stain

What is being measured

The primary outcome is the main question the study is designed to answer.

Helicobacter Pylori Eradication Rate
Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Jun 2012

First posted17 Oct 2011 (estimated)
Study startAug 2011
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Peptic UlcerStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 924 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01453036
Sponsor's protocol ID: CUK
Status last verified: Jul 2013
First submitted: 29 Sep 2011
Last updated: 27 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Cho DK, Park SY, Kee WJ, Lee JH, Ki HS, Yoon KW, Cho SB, Lee WS, Joo YE, Kim HS, Choi SK, Rew JS. [The trend of eradication rate of Helicobacter pylori infection and clinical factors that affect the eradication of first-line therapy]. Korean J Gastroenterol. 2010 Jun;55(6):368-75. doi: 10.4166/kjg.2010.55.6.368. Korean.
PubMed 20571304
Bang SY, Han DS, Eun CS, Kim JE, Ahn SB, Sohn JH, Jeon YC, Kang JO. [Changing patterns of antibiotic resistance of Helicobacter pylori in patients with peptic ulcer disease]. Korean J Gastroenterol. 2007 Dec;50(6):356-62. Korean.
PubMed 18159172

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peptic Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Eradication of Helicobacter Pylori According to 23S rRNA Point Mutations Associated With Clarithromycin Resistance
ClinicalTrials.gov ID: NCT01453036
Acronym / sponsor ID: CUK
Conditions: Peptic Ulcer, Helicobacter Pylori Infection
Keywords: Peptic ulcer, Helicobacter pylori, Clarithromycin, 23S rRNA, Resistance
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 924 participants (actual)
Lead sponsor: Jin Il KimUniversity, hospital or other
Collaborators: Korean College of Helicobacter and Upper Gastrointestinal Research
Study start: Aug 2011
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 17 Oct 2011 (estimated)
Results: Posted 27 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23S rRNA point mutation of Helicobacter pylori is associated clarithromycin resistance
Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment regimens containing a proton pump inhibitor and combination of two antibiotics (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate Helicoabacter pylori more successfully
Material \& methods The investigators enroll patients diagnosed with peptic ulcer, endoscopically. Helicobacter pylori is documented with Urea breath test or silver staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation, the investigators consider as resistance to clarithromycin and choose the treatment regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin, clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare eradication rate with conventional treatment,proton pump inhibitor, amoxicillin, clarithromycin.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Conventional AOC group	Active comparator	Procedure: UBT test & Gastroenterology with biopsy c silver stainThe investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
Mutation test group	Active comparator	Procedure: 23S rRNA point mutation test of Helicobacter pylori, Procedure: UBT test & Gastroenterology with biopsy c silver stainMutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
Conventional AOM group	Active comparator	Procedure: UBT test & Gastroenterology with biopsy c silver stainThe investigators do not perform mutation test in the conventional group apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

20 - 75 years old
Peptic ulcer (gastric ulcer, duodenal ulcer)
Helicobacter pylori positive

Key exclusion criteria (4 listed)

Major comorbidities
Pregnancy
History of Helicobacter pylori eradication
History of gastric surgery or other cancers, except to endoscopic treatment due to gastric lesion

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
23S rRNA point mutation test of Helicobacter pyloriAlso: Seeplex ClaR-Helicobacter pylori polymerase chain reaction kit of Seegene Incorporated, Seoul, Koreamutation test group>> Helicobacter pylori polymerase chain reaction kit by dual-priming oligonucleotide-based multiplex polymerase chain reaction system before eradication of Helicobacter pylori at mutation test groupConventional Conventional AOC group, Conventional AOM group >> no intervention	Procedure or surgery	Mutation test group
UBT test & Gastroenterology with biopsy c silver stainUBT test \& Gastroenterology with biopsy c silver stain due to indentify H. pylori infection Conventional AOM group, Conventional AOC group, Mutation test group >> intervention	Procedure or surgery	Conventional AOC group, Conventional AOM group, Mutation test group

Primary outcome

Helicobacter Pylori Eradication Rate
Time frame: 8 weeks
Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.

Results and safety

Results posted to the registry on 27 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Conventional AOC Group	308	282
Mutation Test Group	308	193
Convential AOM Group	308	277

Primary outcome: Helicobacter Pylori Eradication Rate

Time frame: 8 weeks. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Convential AOC Group n = 308	Mutation Test Group n = 218	Convential AOM Group n = 308
Value	75.9 (70.2 to 81.6)	91.2 (88.9 to 93.4)	79.1 (73.7 to 84.5)

Population analysed: Each convential AOC, AOM group : 308 patients Mutation test gorup : H. pylori was not detected by PCR 90 patient , total 218 patient predicted prevalence - 50%, expected dropout rate -15%, predicted eradication rate - 80%, significance level - 0.05, statistical power - 90%

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Convential AOC Group	0 of 308 (0%)	0 of 308 (0%)	Not reported
Convential AOM Group	0 of 308 (0%)	0 of 308 (0%)	Not reported
Mutation Test Group	0 of 218 (0%)	0 of 218 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20571304Cho DK, Park SY, Kee WJ, Lee JH, Ki HS, Yoon KW, Cho SB, Lee WS, Joo YE, Kim HS, Choi SK, Rew JS. [The trend of eradication rate of Helicobacter pylori infection and clinical factors that affect the eradication of first-line therapy]. Korean J Gastroenterol. 2010 Jun;55(6):368-75. doi: 10.4166/kjg.2010.55.6.368. Korean.
Results publication: PubMed 18159172Bang SY, Han DS, Eun CS, Kim JE, Ahn SB, Sohn JH, Jeon YC, Kang JO. [Changing patterns of antibiotic resistance of Helicobacter pylori in patients with peptic ulcer disease]. Korean J Gastroenterol. 2007 Dec;50(6):356-62. Korean.

Related trials for Peptic Ulcer

Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
RecruitingObservational study
Efficacy and Safety of Esomeprazole 40 mg IV in Post-Surgical Patients Admitted to the ICU
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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.

Hyun Jeong Lee, fellow principal investigator

Yeouido St. Mary's Hospital, The Catholic University of Korea

Dae Young Cheung, professor principal investigator

Yeouido St. Mary's Hospital, The Catholic University of Korea

Seong Su Kim, professor principal investigator

The Catholic University of Korea

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 4 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: finished, as of the sponsor's last update on 27 Sep 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Helicobacter Pylori Eradication Rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01453036, which also lists 2 linked publications.

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 27 Sep 2013.