Helicobacter Pylori InfectionPhase 4NCT04348786
Comparing Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinadizole on Treatment Helicobacter Pylori
A Phase 4 study testing Doxycycline and Levofloxacin 500mg in people with Helicobacter Pylori Infection, run by Damascus Hospital at 1 site in Syria.
Trial summary
Comparison Efficacy of 10-days Therapy with Doxycycline with Bismuth Subsalicylate Versus Levofloxacine with Tinadizole on Eradication of Helicobacter Pylori in Syrian population. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Doxycycline and Levofloxacin 500mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSyria
- Study dates
- 1 Feb 2019to 1 Sep 2020
- 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
- Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
- Positive rapid urease test (CLOtest).
- Histologic evidence of H. pylori by modified Giemsa staining.
- Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.
Who cannot join
- Children and teenagers aged less than 18 years.
- Previous eradication treatment for H. pylori.
- Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
- History of gastrectomy.
- Gastric malignancy, including adenocarcinoma and lymphoma,
- Previous allergic reaction to antibiotics (Amoxicillin, Tinadizole,
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- Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
- Contraindication to treatment drugs.
- Pregnant or lactating women.
- Severe concurrent disease.
- Liver cirrhosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population
Comparison Efficacy of 10-days Therapy with Doxycycline with Bismuth Subsalicylate Versus Levofloxacine with Tinadizole on Eradication of Helicobacter Pylori in Syrian population.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Doxycycline, Levofloxacin 500mg
- Keywords
- Doxycyclien, Bismuth Subsalicylate, Helicobacter Pylori, levofloxacine, tinadizole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Tinadizole, Esomeprazole, Bismuth subsalicylate
Doxycylcine 100 mg bid ,esomprazole 20 bid,Bismuth subsalicylate 262 tab.2 tab q.i.d,Tinadizole 500 bid
Levofloxacin 500mgDrug
Also called Amoxicilline, Esomeprazol, Tinadiole
Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid
| Study group | Role | What they receive |
|---|---|---|
| Doxycyclien | Experimental | Measure eradication rate of Helicobacter pylori infection with Doxycycline and bismuth subsalicylate Receives: Drug: Doxycycline |
| Levofloxacine | Active comparator | Measure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole Receives: Drug: Levofloxacin 500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate of Helicobacter pylori infection
Eradication rate of Helicobacter infected patients
Measured: 8 week from begning of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Feb 2019
- Primary completion30 Aug 2020
- Study completion1 Sep 2020
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marouf Alhalabi, Damascus Hospital
- Investigators
- Marouf M Alhalabi, MD, Principal investigator, general assambly of damascus hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348786
- Sponsor's protocol ID
- G1-19
- Status last verified
- Sep 2020
- First submitted
- 29 Jan 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Alhalabi M, Alassi MW, Alaa Eddin K, Cheha K. Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial. BMC Infect Dis. 2021 Jul 4;21(1):642. doi: 10.1186/s12879-021-06356-5.
PubMed 34218802
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of 14-day Therapy Doxycycline With Bismuth Subsalicylate Versus Levofloxacin With Tinidazole on Rate of Eradication of Helicobacter Pylori Infected Patients on Syrian Population
- ClinicalTrials.gov ID
- NCT04348786
- Acronym / sponsor ID
- G1-19
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Doxycyclien, Bismuth Subsalicylate, Helicobacter Pylori, levofloxacine, tinadizole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Damascus HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- 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.
Comparison Efficacy of 10-days Therapy with Doxycycline with Bismuth Subsalicylate Versus Levofloxacine with Tinadizole on Eradication of Helicobacter Pylori in Syrian population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doxycyclien | Experimental | Drug: DoxycyclineMeasure eradication rate of Helicobacter pylori infection with Doxycycline and bismuth subsalicylate |
| Levofloxacine | Active comparator | Drug: Levofloxacin 500mgMeasure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods:
- Positive rapid urease test (CLOtest).
- Histologic evidence of H. pylori by modified Giemsa staining.
- Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.
Key exclusion criteria (11 listed)
- Children and teenagers aged less than 18 years.
- Previous eradication treatment for H. pylori.
- Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
- History of gastrectomy.
- Gastric malignancy, including adenocarcinoma and lymphoma,
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 |
|---|---|---|
| DoxycyclineAlso: Tinadizole, Esomeprazole, Bismuth subsalicylateDoxycylcine 100 mg bid ,esomprazole 20 bid,Bismuth subsalicylate 262 tab.2 tab q.i.d,Tinadizole 500 bid | Drug | Doxycyclien |
| Levofloxacin 500mgAlso: Amoxicilline, Esomeprazol, TinadioleLevofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid | Drug | Levofloxacine |
Primary outcome
Eradication rate of Helicobacter pylori infection
Time frame: 8 week from begning of treatment
Eradication rate of Helicobacter infected patients
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 16 Sep 2020.
- Derived from this study: PubMed 34218802Alhalabi M, Alassi MW, Alaa Eddin K, Cheha K. Efficacy of two-week therapy with doxycycline-based quadruple regimen versus levofloxacin concomitant regimen for helicobacter pylori infection: a prospective single-center randomized controlled trial. BMC Infect Dis. 2021 Jul 4;21(1):642. doi: 10.1186/s12879-021-06356-5.
- Individual participant dataSharing planned: Yes
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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.
Marouf M Alhalabi, MD principal investigator
general assambly of damascus hospital
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 Doxycycline and Levofloxacin 500mg in people with Helicobacter Pylori Infection, run by Damascus Hospital at 1 site in Syria.
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 11 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 16 Sep 2020. 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 Syria. 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?
Eradication rate of Helicobacter pylori infection (time frame: 8 week from begning 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 NCT04348786, 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 16 Sep 2020.