Helicobacter InfectionPhase 4960025NCT00656968

Comparison of Sequential or Concomitant Therapy for Helicobacter Pylori Infection

A Phase 4 study testing 10-day sequential treatment and 10-day concomitant therapy in people with Helicobacter Infection, run by Kaohsiung Veterans General Hospital. at 2 sites in Taiwan.

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

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Helicobacter Infection
What is being tested?: 10-day sequential treatment and 10-day concomitant therapy
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 232 participants
Where: 2 sitesTaiwan
Study dates: May 2007to Jun 2010
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or non-pregnant female aged 18 to 75 years inclusively.
Mental and legal ability to give a written informed consent.
Active H. pylori infection.

Who cannot join

Previous surgery of the stomach such as partial gastrectomy.
Use of antibiotics within the preceding 30 days.
Regular use of bismuth compounds (>3 times per week) in the 30 days before enrollment.
Presence of serious medical condition(s) precluding participation or endoscopy with biopsy.
Use of concomitant medication(s) known to interact with study medication.
Presence of Zollinger-Ellison Syndrome.

Show all 12Show fewer

Pregnancy or lactation.
Allergy to any of the study medications.
Contraindication(s) to the use of any of the study drugs.
Participation in a clinical trial within the last 30 days.
Unwillingness to abstain from alcoholic beverages.
Patients taking other medications including warfarin, antipsychotics, or chronic NSAIDs will also be excluded. Aspirin at a dose not more than 325 mg/day will be permitted.

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

Chung-Ho Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung City, 813

Other trials in Taiwan

About this study

Official title: Sequential Versus Concomitant Therapy for Helicobacter Pylori Infection

Helicobacter pylori is a bacteria that infects the lining of the stomach and is associated with ulcers. Helicobacter pylori may also increase the long-term risk of developing certain forms of gastric cancer. Curing this infection generally requires that patients take 2 or more antibiotic medications and a stomach acid suppressing medication for about two weeks. Current treatments do not always cure the infection and a new treatment is being tested in this study. The drugs involved in the new 4 drug treatment have been widely used for treatment of this infection. It remains unknown what is the best and most cost effective way to give them. This study will compare three different ways of using these drugs.

Subjects must have active Helicobacter pylori infection in order to participate in this study.

Read the detailed description

The purpose of this study is to compare different methods of giving combination drug therapy for treating Helicobacter pylori infection of the stomach. The entire study will last less than 2 years. Each subject will be participating in the study for approximately 60 days.

A total of 360 subjects will be asked to participate in this study.

Before participating in this study, subject's must have undergone to confirm the presence and to assess the susceptibility of Helicobacter pylori. Qualified subjects will receive 4 drugs which are to be taken as part of the study treatment: an acid suppressing drug (name), amoxicillin, clarithromycin and metronidazole. The doses are 1 grams of amoxicillin, 40 mg of esomeprazole (Nexium), 500 mg of metronidazole and 250 mg of clarithromycin. Each drug will be given twice a day to be taken twice a day with the morning and evening meals. Subjects will receive one of three different combinations. The choice of which will be randomly chosen by the use of a computer program. The regimes are: all 4 drugs daily for 5 days, all 4 drugs daily for 10 days, and two drugs (esomeprazole and amoxicillin) for 5 days then all for drugs for 5 additional days.

Subjects will be asked to return within 4 days after completion of the treatment to evaluate how they did with the drugs. They will be asked bring back all unused medication and the bottles or containers that the medicine was packaged in. Your medication use and tolerance to the study drugs will be assessed. The treatment portion of the study will be complete at this point.

Evaluation of the effect of the treatment will take place 4-6 weeks after the end of therapy. Subjects will come back to the study site and will have a UBT or repeat endoscopy, if clinically indicated to verify that the Helicobacter pylori has been cured. Subjects will be asked not to take antibiotics or any other drugs that may affect the outcome of the breath test used to confirm that the treatment was successful.

Conditions: Helicobacter Infection
Being tested: 10-day sequential treatment, 10-day concomitant therapy
Keywords: peptic ulcer disease, gastric cancer, therapeutics
Medical subject headings: Helicobacter Infections, Peptic Ulcer, Stomach Neoplasms

What participants receive

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

10-day sequential treatmentDrug
Also called Nexium-based sequential therapy
esomeprazole (40 mg daily) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, metronidazole (500 mg, bid) from day 6 to day 10
10-day concomitant therapyDrug
Also called Nexium-based quadruple therapy
esomeprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 10, clarithromycin (500 mg, bid) from day 1 to day 10, metronidazole (500 mg, bid) from day 1 to day 10

Study groups in NCT00656968
Study group	Role	What they receive
10-day concomitant therapy	Active comparator	esomeprazole and amoxicillin and clarithromycin and metronidazole for 10 days Receives: Drug: 10-day concomitant therapy
10-day sequential therapy	Experimental	esomeprazole and amoxicillin for 5 days, followed by esoprazole and clarithromycin and metronidazole for 5 more days Receives: Drug: 10-day sequential treatment

What is being measured

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

Number of Participants in Which H. Pylori Was Eradicated
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Measured: one month after finishing study drugs
Number of Participants Who Had Good Drug Compliance
Good drug compliance is defined as taking equal to or more than 80% of eradication medicines
Measured: one month after finishing test therapy

Timeline

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

May 2007Jun 2010

First posted14 Apr 2008 (estimated)
Study startMay 2007
Primary completionJun 2010
Study completionJun 2010

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 (1)Papers the sponsor has linked to this study.
Other trials for Helicobacter InfectionStudies 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 232 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00656968
Sponsor's protocol ID: KMU-IRB00003151
Other IDs: VGHKS95-CT3-11
Acronym: 960025
Status last verified: Sep 2015
First submitted: 3 Jan 2008
Last updated: 30 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Francavilla R, Lionetti E, Castellaneta SP, Magista AM, Boscarelli G, Piscitelli D, Amoruso A, Di Leo A, Miniello VL, Francavilla A, Cavallo L, Ierardi E. Improved efficacy of 10-Day sequential treatment for Helicobacter pylori eradication in children: a randomized trial. Gastroenterology. 2005 Nov;129(5):1414-9. doi: 10.1053/j.gastro.2005.09.007.
PubMed 16285942

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

RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
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

All Helicobacter Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sequential Versus Concomitant Therapy for Helicobacter Pylori Infection
ClinicalTrials.gov ID: NCT00656968
Acronym / sponsor ID: 960025 / KMU-IRB00003151
Conditions: Helicobacter Infection
Keywords: peptic ulcer disease, gastric cancer, therapeutics
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 232 participants (actual)
Lead sponsor: Kaohsiung Veterans General Hospital.University, hospital or other
Collaborators: Baylor College of Medicine
Study start: May 2007
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 14 Apr 2008 (estimated)
Results: Posted 2 Aug 2011

Clinical summary

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

Subjects must have active Helicobacter pylori infection in order to participate in this study.

Detailed description

A total of 360 subjects will be asked to participate in this study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
10-day concomitant therapy	Active comparator	Drug: 10-day concomitant therapyesomeprazole and amoxicillin and clarithromycin and metronidazole for 10 days
10-day sequential therapy	Experimental	Drug: 10-day sequential treatmentesomeprazole and amoxicillin for 5 days, followed by esoprazole and clarithromycin and metronidazole for 5 more days

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or non-pregnant female aged 18 to 75 years inclusively.
Mental and legal ability to give a written informed consent.
Active H. pylori infection.

Key exclusion criteria (12 listed)

Previous surgery of the stomach such as partial gastrectomy.
Use of antibiotics within the preceding 30 days.
Regular use of bismuth compounds (>3 times per week) in the 30 days before enrollment.
Presence of serious medical condition(s) precluding participation or endoscopy with biopsy.
Use of concomitant medication(s) known to interact with study medication.

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
10-day sequential treatmentAlso: Nexium-based sequential therapyesomeprazole (40 mg daily) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 5, clarithromycin (500 mg, bid) from day 6 to day 10, metronidazole (500 mg, bid) from day 6 to day 10	Drug	10-day sequential therapy
10-day concomitant therapyAlso: Nexium-based quadruple therapyesomeprazole (40 mg, bid) from day 1 to day 10, amoxicillin (1 g, bid) from day 1 to day 10, clarithromycin (500 mg, bid) from day 1 to day 10, metronidazole (500 mg, bid) from day 1 to day 10	Drug	10-day concomitant therapy

Primary outcome

Number of Participants in Which H. Pylori Was Eradicated
Time frame: one month after finishing study drugs
Evaluate eradication outcome by endoscopy urease test and histology or urea breath test
Number of Participants Who Had Good Drug Compliance
Time frame: one month after finishing test therapy
Good drug compliance is defined as taking equal to or more than 80% of eradication medicines

Results and safety

Results posted to the registry on 2 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Concomitant Therapy (A)	115	115
Sequential Therapy (B)	117	117

Primary outcome: Number of Participants in Which H. Pylori Was Eradicated

Time frame: one month after finishing study drugs. Number. Unit: participants

Measure	Concomitant Therapy (A) n = 115	Sequential Therapy (B) n = 117
Value	92	95

Primary outcome: Number of Participants Who Had Good Drug Compliance

Time frame: one month after finishing test therapy. Number. Unit: participants

Measure	Concomitant Therapy (A) n = 115	Sequential Therapy (B) n = 117
Value	106	104

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Concomitant Therapy (A)	0 of 115 (0%)	31 of 115 (27%)	Not reported
Sequential Therapy (B)	0 of 117 (0%)	36 of 117 (30.8%)	Not reported

Limitations and caveats (from the sponsor): The trial was performed in a single country

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16285942Francavilla R, Lionetti E, Castellaneta SP, Magista AM, Boscarelli G, Piscitelli D, Amoruso A, Di Leo A, Miniello VL, Francavilla A, Cavallo L, Ierardi E. Improved efficacy of 10-Day sequential treatment for Helicobacter pylori eradication in children: a randomized trial. Gastroenterology. 2005 Nov;129(5):1414-9. doi: 10.1053/j.gastro.2005.09.007.

Related trials for Helicobacter Infection

RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
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

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.

Ching-Kuan Liu, MD, PhD study chair

Kaohsiung Medical Univestity

David Y Graham, MD study chair

Baylor College of Medicine

Antone R Opekun, PA-C study director

Baylor College of Medicine

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 10-day sequential treatment and 10-day concomitant therapy in people with Helicobacter Infection, run by Kaohsiung Veterans General Hospital. at 2 sites in Taiwan.

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 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: finished, as of the sponsor's last update on 30 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. 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 2 Aug 2011). 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?

Number of Participants in Which H. Pylori Was Eradicated (time frame: one month after finishing study drugs). The study lists 2 primary outcomes in all. 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 NCT00656968, which also lists 1 linked publication.

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 30 Sep 2015.