Helicobacter InfectionPhase 4NCT00841854
Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication
A Phase 4 study testing pantoprazole, bismuth and metronidazole in people with Helicobacter Infection, run by Asan Medical Center at 1 site in South Korea.
Trial summary
At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Infection
- What is being tested?
- pantoprazole, bismuth and metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2008to Nov 2010
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- H. pylori infection
- Aged between 18-80 years
- Are willing to received eradication therapy for H. pylori
Who cannot join
- Children and teenagers aged less than 18 years or over 80 years
- Previous eradication therapy for H. pylori
- History of gastrectomy
- Previous allergic reaction to antibiotics
- Use of prompt pump inhibitors and antibiotics in the recent 4 weeks
- Active upper GI bleeding in the recent 1 week
Show all 9Show fewer
- Contraindication to treatment drugs
- Pregnant or lactating women
- Severe concurrent disease or malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication.
At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.
- Conditions
- Helicobacter Infection
- Being tested
- pantoprazole, bismuth, metronidazole, tetracycline
- Keywords
- Helicobacter pylori, Bismuth, Salvage treatment, Metronidazole
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pantoprazoleDrug
pantoprazole 40mg bid
bismuthDrug
bismuth 300mg qid
metronidazoleDrug
metronidazole 500mg tid
tetracyclineDrug
tetracycline 500mg qid
| Study group | Role | What they receive |
|---|---|---|
| PBMT7 | Active comparator | pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days Receives: Drug: pantoprazole; Drug: bismuth; Drug: metronidazole; Drug: tetracycline |
| PBMT14 | Active comparator | pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days Receives: Drug: pantoprazole; Drug: bismuth; Drug: metronidazole; Drug: tetracycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether the two week group yield a higher eradication rate comparing to the one week group.
Measured: At least four week after completion of treatment
Secondary outcomes (1)
side effect
Measured: four weeks after completion of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionMay 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter InfectionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University, Pacific Pharmaceuticals
- Responsible party
- Principal investigator, Hwoon-Yong Jung, Asan Medical Center
- Investigators
- Hwoon-Yong Jung, M.D, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841854
- Sponsor's protocol ID
- 2008-0088
- Status last verified
- Dec 2016
- First submitted
- 10 Feb 2009
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chung JW, Lee JH, Jung HY, Yun SC, Oh TH, Choi KD, Song HJ, Lee GH, Kim JH. Second-line Helicobacter pylori eradication: a randomized comparison of 1-week or 2-week bismuth-containing quadruple therapy. Helicobacter. 2011 Aug;16(4):289-94. doi: 10.1111/j.1523-5378.2011.00844.x.
PubMed 21762268
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication.
- ClinicalTrials.gov ID
- NCT00841854
- Acronym / sponsor ID
- 2008-0088
- Conditions
- Helicobacter Infection
- Keywords
- Helicobacter pylori, Bismuth, Salvage treatment, Metronidazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Inje University, Pacific Pharmaceuticals
- Study start
- Jun 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 11 Feb 2009 (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.
At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBMT7 | Active comparator | Drug: pantoprazole, Drug: bismuth, Drug: metronidazole, Drug: tetracyclinepantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days |
| PBMT14 | Active comparator | Drug: pantoprazole, Drug: bismuth, Drug: metronidazole, Drug: tetracyclinepantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- H. pylori infection
- Aged between 18-80 years
- Are willing to received eradication therapy for H. pylori
Key exclusion criteria (9 listed)
- Children and teenagers aged less than 18 years or over 80 years
- Previous eradication therapy for H. pylori
- History of gastrectomy
- Previous allergic reaction to antibiotics
- Use of prompt pump inhibitors and antibiotics in the recent 4 weeks
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 |
|---|---|---|
| pantoprazolepantoprazole 40mg bid | Drug | PBMT14, PBMT7 |
| bismuthbismuth 300mg qid | Drug | PBMT14, PBMT7 |
| metronidazolemetronidazole 500mg tid | Drug | PBMT14, PBMT7 |
| tetracyclinetetracycline 500mg qid | Drug | PBMT14, PBMT7 |
Primary outcome
Whether the two week group yield a higher eradication rate comparing to the one week group.
Time frame: At least four week after completion of treatment
1 secondary outcome
side effect
Time frame: four weeks after completion of medication
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Derived from this study: PubMed 21762268Chung JW, Lee JH, Jung HY, Yun SC, Oh TH, Choi KD, Song HJ, Lee GH, Kim JH. Second-line Helicobacter pylori eradication: a randomized comparison of 1-week or 2-week bismuth-containing quadruple therapy. Helicobacter. 2011 Aug;16(4):289-94. doi: 10.1111/j.1523-5378.2011.00844.x.
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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.
Hwoon-Yong Jung, M.D principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pantoprazole, bismuth and metronidazole in people with Helicobacter Infection, run by Asan Medical Center 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 3 inclusion and 9 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 6 Dec 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Whether the two week group yield a higher eradication rate comparing to the one week group. (time frame: At least four week after completion of treatment). 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 NCT00841854, 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 6 Dec 2016.