Helicobacter Pylori InfectionPhase 3NCT01131026
Efficacy and Safety Evaluation of Levofloxacin Triple Therapy for Helicobacter Pylori Eradication
A Phase 3 study testing Levofloxacin, Amoxicillin and Lansoprazole in people with Helicobacter Pylori Infection, run by Deva Holding A.S. at 1 site in Turkey (Türkiye).
Trial summary
Today, although the triple treatment with clarithromycin accepted as the primary treatment for Helicobacter pylori infection eradication is well tolerated, the eradication has been decreased to 65 %. However, the eradication resulting from TRIOL treatment with levofloxacin is expected to be 75 % or higher. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Levofloxacin, Amoxicillin and Lansoprazole
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2010to Aug 2011
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting to an endoscopy
- Signing the informed consent form
- Not receiving Helicobacter pylori eradication treatment before
- Showing Helicobacter pylori infection by rapid urease test and/or Giemsa staining
- Being older than 18 years of age
Who cannot join
- Being younger than 18 years of age
- Receiving H. pylori eradication treatment previously
- Having gastrectomy or vagotomy in medical history
- Having gastric malignancy, including adenocarcinoma and lymphoma
- Having other severe malignant disease
- Previously having allergic reaction to antibiotics (amoxicillin, levofloxacin) and proton pump inhibitors (lansoprazole)
Show all 24Show fewer
- Using prompt pump inhibitors (lansoprazole) and antibiotics (amoxicillin, clarithromycin, levofloxacin) in the last 4 weeks
- Having active upper GI bleeding in the last week
- Being pregnant or lactating
- Taking long term high dosages of aspirin, corticosteroid and other NSAIDs in the last 4 weeks
- Taking any antibiotics or proton pump inhibitors other than the study medication during the study period
- Taking antacids and/or H2-blockers during the study period
- Taking bismuth compounds within four weeks prior to and during the study period
- Having dysphasia or vomiting as major symptoms
- Having psychiatric, neurological, or behavioral disorders that may interfere with the conduct or interpretation of the study
- Having severe concomitant disease of the cardiovascular, pulmonic, hepatic, renal, hematological, lymphatic, metabolic, and endocrine system.
- Having known uncontrolled hypertension
- Being immunocompromised
- Showing clinically significant abnormal vital signs
- Having clinically significant abnormal ECG findings
- Presenting clinically significant abnormal laboratory data at screening, or any abnormal laboratory value that could interfere with the assessment of safety
- Being exposed to any investigational drug within 30 days prior to screening
- Having known hypersensitivity to or contraindication against fluoroquinolones.
- Having current diagnosis or known history of substance abuse.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology
Kayseri, 38039
About this study
Official title: A Monocentric, Open-label, Efficacy and Safety Evaluation Study of the Triple Therapy of 500 mg Levofloxacin, 1000 mg Amoxicillin and 30 mg Lansoprazole on Helicobacter Pylori Eradication in 60 Patients Infected With H. Pylori
Today, although the triple treatment with clarithromycin accepted as the primary treatment for Helicobacter pylori infection eradication is well tolerated, the eradication has been decreased to 65 %. However, the eradication resulting from TRIOL treatment with levofloxacin is expected to be 75 % or higher. If the target results can be reached, it will be concluded that TRIOL treatment with levofloxacin will be an alternative to the triple treatment with clarithromycin as the primary treatment.
Read the detailed description
The primary end point in this study is appointed to be "Helicobacter pylori infection eradication with TRIOL treatment" and the secondary end point as "safety". The study involves the investigation of the efficacy and safety of the triple treatment consisting of 500 mg levofloxacin, 1000 mg amoxicillin and 30 mg lansoprazole on Helicobacter pylori eradication in 60 patients with Helicobacter pylori infection.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Levofloxacin, Amoxicillin, Lansoprazole
- Keywords
- Helicobacter pylori, levofloxacin, amoxicillin, lansoprazole, efficacy, safety, triple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevofloxacinDrug
Also called Floxilevo 500 mg Tablet
tablet, 500 mg, once a day for ten days
AmoxicillinDrug
Also called Dentamax 1 gr Tablet
tablet, 1000 mg, once a day for ten days
LansoprazoleDrug
Also called Degastrol 30 mg Capsule
capsule, 30 mg, twice a day for ten days
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori infection eradication
After 6 weeks from the end of the TRIOL treatment, demonstrating the ratio of patients who do not develop Helicobacter pylori infection by rapid urease test and Giemsa staining.
Measured: 6 weeks
Secondary outcomes (1)
Safety
During the study all patients will be examined at the determined timepoints in the protocol in regard to any type of clinical adverse event. These examinations involve clinical and laboratory examinations of which the results will be recorded in the final study report and discussed with respect to the current literature.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deva Holding A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TNC Ilac Arastirma Gelistirme Danismanlik San. ve Tic. Ltd. Sti., TC Erciyes University
- Investigators
- Mehmet Yucesoy, MD, Principal investigator, Kayseri, Erciyes University School of Medicine Hospital, Department of Internal Medicine and GastroenterologyRecep S Alpan, MD, PhD, MSc, Study director, TNC Pharmaceuticals Research, Development and Consultancy Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131026
- Sponsor's protocol ID
- DV-09-0015
- Status last verified
- Aug 2011
- First submitted
- 12 May 2010
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric, Open-label, Efficacy and Safety Evaluation Study of the Triple Therapy of 500 mg Levofloxacin, 1000 mg Amoxicillin and 30 mg Lansoprazole on Helicobacter Pylori Eradication in 60 Patients Infected With H. Pylori
- ClinicalTrials.gov ID
- NCT01131026
- Acronym / sponsor ID
- DV-09-0015
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, levofloxacin, amoxicillin, lansoprazole, efficacy, safety, triple therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Deva Holding A.S.Industry (pharma, biotech, devices)
- Collaborators
- TNC Ilac Arastirma Gelistirme Danismanlik San. ve Tic. Ltd. Sti., TC Erciyes University
- Study start
- Jun 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 May 2010 (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.
Today, although the triple treatment with clarithromycin accepted as the primary treatment for Helicobacter pylori infection eradication is well tolerated, the eradication has been decreased to 65 %. However, the eradication resulting from TRIOL treatment with levofloxacin is expected to be 75 % or higher. If the target results can be reached, it will be concluded that TRIOL treatment with levofloxacin will be an alternative to the triple treatment with clarithromycin as the primary treatment.
Detailed description
The primary end point in this study is appointed to be "Helicobacter pylori infection eradication with TRIOL treatment" and the secondary end point as "safety". The study involves the investigation of the efficacy and safety of the triple treatment consisting of 500 mg levofloxacin, 1000 mg amoxicillin and 30 mg lansoprazole on Helicobacter pylori eradication in 60 patients with Helicobacter pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consenting to an endoscopy
- Signing the informed consent form
- Not receiving Helicobacter pylori eradication treatment before
- Showing Helicobacter pylori infection by rapid urease test and/or Giemsa staining
- Being older than 18 years of age
Key exclusion criteria (24 listed)
- Being younger than 18 years of age
- Receiving H. pylori eradication treatment previously
- Having gastrectomy or vagotomy in medical history
- Having gastric malignancy, including adenocarcinoma and lymphoma
- Having other severe malignant disease
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 |
|---|---|---|
| LevofloxacinAlso: Floxilevo 500 mg Tablettablet, 500 mg, once a day for ten days | Drug | – |
| AmoxicillinAlso: Dentamax 1 gr Tablettablet, 1000 mg, once a day for ten days | Drug | – |
| LansoprazoleAlso: Degastrol 30 mg Capsulecapsule, 30 mg, twice a day for ten days | Drug | – |
Primary outcome
Helicobacter pylori infection eradication
Time frame: 6 weeks
After 6 weeks from the end of the TRIOL treatment, demonstrating the ratio of patients who do not develop Helicobacter pylori infection by rapid urease test and Giemsa staining.
1 secondary outcome
Safety
Time frame: 6 weeks
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 9 Aug 2011.
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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.
Mehmet Yucesoy, MD principal investigator
Kayseri, Erciyes University School of Medicine Hospital, Department of Internal Medicine and Gastroenterology
Recep S Alpan, MD, PhD, MSc study director
TNC Pharmaceuticals Research, Development and Consultancy Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levofloxacin, Amoxicillin and Lansoprazole in people with Helicobacter Pylori Infection, run by Deva Holding A.S. at 1 site in Turkey (Türkiye).
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 5 inclusion and 24 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 9 Aug 2011. 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 Turkey (Türkiye). 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Helicobacter pylori infection eradication (time frame: 6 weeks). 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 9 Aug 2011.