Helicobacter InfectionPhase 4NCT02711176
Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection
A Phase 4 study testing Nexium, Tinafas and Tavanex in people with Helicobacter Infection, run by Zahra Vahdat Shariatpanahi at 1 site in Iran.
Trial summary
This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Infection
- What is being tested?
- Nexium, Tinafas and Tavanex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteIran
- Study dates
- Sep 2016to 27 Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who proved H. pylori infection following three methods
- Positive rapid urease test
- Histologic evidence of H. pylori by modified Giemsa staining
- Positive stool Antigen Test
Who cannot join
- Patients who received eradication therapy for H. pylori infection, previously
- H. pylori eradication failure because of poor compliance
- The administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
- Advanced gastric cancer or other malignancy
- Abnormal liver function or liver cirrhosis
- Abnormal renal function or chronic kidney disease
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- Other severe concurrent diseases
- Previous allergic reactions to the study drugs
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.
Read the detailed description
Multiple regimens have been evaluated for H. pylori therapy in randomized controlled trials The treatment regimen that is selected must be effective, but considerations such as cost, side effects, and ease of administration should also be taken into account. Despite the number of studies, the optimal therapeutic regimen has not yet been defined.
The regimen most commonly recommended for first line treatment of H. pylori is triple therapy with a PPI, amoxicillin and clarithromycin for 14 days. However, the multi-drug application is associated with remarkable side effects and it is not uncommon not to be able to complete a treatment course. Thus, treatment failure is associated with H. pylori strains that are resistant to the commonly used antibiotics. This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.
- Conditions
- Helicobacter Infection
- Being tested
- Nexium, Tinafas, Tavanex, Lanzol, Klacid
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexiumDrug
Also called Esomeprazole
Patients in experimental group will receive the 14 day single dose of Nexium 40 mg daily
TinafasDrug
Also called Tinidazole
Patients in experimental group will receive the 14 day single dose regimen of Tinafas 1 g daily
TavanexDrug
Also called Levofluxacine
Patients in experimental group will receive the 14 day single dose of Tavanex 500 mg daily
LanzolDrug
Also called lansoprazole
Patients in active comparator group will receive the 14 day lansoprazole (Lanzol) 30 mg twice daily
KlacidDrug
Also called clarithromycin
Patients in active comparator group will receive the 14 day clarithromycin (Klacid) 500 mg twice daily twice daily
IramoxDrug
Also called amoxicillin
Patients in active comparator group will receive the 14 day amoxicillin (Iramox) 1 g twice daily
| Study group | Role | What they receive |
|---|---|---|
| Tavanex & Nexium & Tinafas | Experimental | Patients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days" Receives: Drug: Nexium; Drug: Tinafas; Drug: Tavanex |
| Lanzol & Klacid &Iramox | Active comparator | Patients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days Receives: Drug: Lanzol; Drug: Klacid; Drug: Iramox |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of H.pylori eradication
Breath Urea Test
Measured: 42 days after study completion
Secondary outcomes (1)
Drug Compliance
Interview
Measured: within the first week after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startSep 2016
- Primary completion27 Mar 2017
- Study completion27 Mar 2017
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.
- 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
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahra Vahdat Shariatpanahi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zahra Vahdat Shariatpanahi, Ilam University of Medical Sciences
- Investigators
- Shaahin Shahbazi, MD, Principal investigator, Assistant Professor, Ilam University of Medical Sciences,Head of Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711176
- Sponsor's protocol ID
- 22/52/1662
- Status last verified
- Jun 2017
- First submitted
- 9 Feb 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Shahbazi S, Vahdat Shariatpanahi Z. Comparison between daily single-dose triple therapy and conventional triple therapy on patient compliance and Helicobacter pylori eradication: A randomized controlled trial. Indian J Gastroenterol. 2018 Nov;37(6):550-554. doi: 10.1007/s12664-018-0916-z. Epub 2019 Jan 12.
PubMed 30635887
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT02711176
- Acronym / sponsor ID
- 22/52/1662
- Conditions
- Helicobacter Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Zahra Vahdat ShariatpanahiUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 27 Mar 2017 (actual)
- First posted
- 17 Mar 2016 (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.
This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.
Detailed description
Multiple regimens have been evaluated for H. pylori therapy in randomized controlled trials The treatment regimen that is selected must be effective, but considerations such as cost, side effects, and ease of administration should also be taken into account. Despite the number of studies, the optimal therapeutic regimen has not yet been defined.
The regimen most commonly recommended for first line treatment of H. pylori is triple therapy with a PPI, amoxicillin and clarithromycin for 14 days. However, the multi-drug application is associated with remarkable side effects and it is not uncommon not to be able to complete a treatment course. Thus, treatment failure is associated with H. pylori strains that are resistant to the commonly used antibiotics. This study is conducted to investigate whether the efficacy of single-dose triple therapy (Esomeprazole 40 mg, Tinidazole 1 g, and Levofluxacine 500 mg) for 14 days is superior to double-dose lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg for 14 days in the treatment of H pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tavanex & Nexium & Tinafas | Experimental | Drug: Nexium, Drug: Tinafas, Drug: TavanexPatients will receive Nexium (Esomeprazole) 40 mg daily and Tinafas (Tinidazole) 1 g daily and Tavanex (Levofloxacin) 500 mg daily for 14 days" |
| Lanzol & Klacid &Iramox | Active comparator | Drug: Lanzol, Drug: Klacid, Drug: IramoxPatients will receive Lanzol (lansoprazole) 30 mg twice daily and Klacid (clarithromycin) 500 mg twice daily and Iramox (amoxicillin) 1 g twice daily for 14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients who proved H. pylori infection following three methods
Key exclusion criteria (9 listed)
- Patients who received eradication therapy for H. pylori infection, previously
- H. pylori eradication failure because of poor compliance
- The administration of antibiotics or the consumption of bismuth salts within 4 weeks or the administration of a proton pump inhibitor (PPI) within 2 weeks
- Advanced gastric cancer or other malignancy
- Abnormal liver function or liver cirrhosis
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 |
|---|---|---|
| NexiumAlso: EsomeprazolePatients in experimental group will receive the 14 day single dose of Nexium 40 mg daily | Drug | Tavanex & Nexium & Tinafas |
| TinafasAlso: TinidazolePatients in experimental group will receive the 14 day single dose regimen of Tinafas 1 g daily | Drug | Tavanex & Nexium & Tinafas |
| TavanexAlso: LevofluxacinePatients in experimental group will receive the 14 day single dose of Tavanex 500 mg daily | Drug | Tavanex & Nexium & Tinafas |
| LanzolAlso: lansoprazolePatients in active comparator group will receive the 14 day lansoprazole (Lanzol) 30 mg twice daily | Drug | Lanzol & Klacid &Iramox |
| KlacidAlso: clarithromycinPatients in active comparator group will receive the 14 day clarithromycin (Klacid) 500 mg twice daily twice daily | Drug | Lanzol & Klacid &Iramox |
| IramoxAlso: amoxicillinPatients in active comparator group will receive the 14 day amoxicillin (Iramox) 1 g twice daily | Drug | Lanzol & Klacid &Iramox |
Primary outcome
The rate of H.pylori eradication
Time frame: 42 days after study completion
Breath Urea Test
1 secondary outcome
Drug Compliance
Time frame: within the first week after study completion
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 8 Jun 2017.
- Derived from this study: PubMed 30635887Shahbazi S, Vahdat Shariatpanahi Z. Comparison between daily single-dose triple therapy and conventional triple therapy on patient compliance and Helicobacter pylori eradication: A randomized controlled trial. Indian J Gastroenterol. 2018 Nov;37(6):550-554. doi: 10.1007/s12664-018-0916-z. Epub 2019 Jan 12.
- Individual participant dataSharing planned: No
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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.
Shaahin Shahbazi, MD principal investigator
Assistant Professor, Ilam University of Medical Sciences,Head of Faculty of Medicine
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 Nexium, Tinafas and Tavanex in people with Helicobacter Infection, run by Zahra Vahdat Shariatpanahi at 1 site in Iran.
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 4 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 8 Jun 2017. 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 Iran. 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?
The rate of H.pylori eradication (time frame: 42 days after study completion). 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 NCT02711176, 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 8 Jun 2017.