Helicobacter Pylori Gastrointestinal Tract InfectionPhase 4NCT03021590
Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
A Phase 4 study testing Clarithromycin 500Mg Oral Tablet and Levofloxacin 500Mg Oral Tablet in people with Helicobacter Pylori Gastrointestinal Tract Infection, run by Damascus Hospital at 1 site in Syria.
Trial summary
Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the Eradication of Helicobacter Pylori in Syrian population Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Helicobacter Pylori Gastrointestinal Tract Infection
- What is being tested?
- Clarithromycin 500Mg Oral Tablet and Levofloxacin 500Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jun 2017to 31 Jan 2022
- 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 75 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: I-Positive rapid urease test (CLOtest). II-Histologic evidence of H. pylori by modified Giemsa staining. III-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, Tinidazole , Levofloxacin) and prompt pump inhibitors (Es-omeprazole).
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- Contraindication to treatment drugs.
- Pregnant or lactating women.
- Severe concurrent disease. Liver cirrhosis. Chronic kidney disease.
- Patients who cannot give informed consent by himself or herself.
Trial locations and contacts
1 site in 1 country.
About this study
Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the Eradication of Helicobacter Pylori in Syrian population
- Being tested
- Clarithromycin 500Mg Oral Tablet, Levofloxacin 500Mg Oral Tablet
- Keywords
- Helicobacter pylori, Helicobacter Infections, Proton Pump Inhibitors, sequential therapy, Clarithromycin, Tinidazole
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clarithromycin 500Mg Oral TabletDrug
Also called Esomeprazole 40Mg Capsule, Amoxicillin 1000Mg Capsule, Tinidazole 500Mg Tablet
Amoxicillin 1000 mg Tablets every 12 hours , Esomeprazole 20 mg Capsule days all
,Clarithromycin 500 mg Tablets and Tinidazole 500 mg Tablets every 12 hours for 14 days all by mouth
Levofloxacin 500Mg Oral TabletDrug
Also called Esomeprazole 40Mg Capsule, Amoxicillin 1000Mg Capsule, Tinidazole 500Mg Tablet
Amoxicillin 1000 mg Tablets , Esomeprazole 20 mg Capsule,Levofloxacin 500 mg Tablets and Tinidazole 500 mg Tablets all every 12 hours for 14 days all by mouth
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycin :Concomitant Therapy | Experimental | Amoxicillin 1000 mg Tablets, Clarithromycin 500 mg Tablets , Tinidazole 500 mg Tablets and Esomeprazole 20 mg Capsule each every 12 hours for 14 days all by mouth Receives: Drug: Clarithromycin 500Mg Oral Tablet |
| Levofloxacin :Concomitant Therapy | Active comparator | Levofloxacin 500 mg Tablets Amoxicillin 1000 mg Tablets,Tinidazole 500 mg Tablets and Esomeprazole 20 mg each every 12 hours for 14 days all by mouth Receives: Drug: Levofloxacin 500Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori Eradication rate
Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
Measured: 6 weeks after eradication therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study start1 Jun 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Why it stopped: No Participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Gastrointestinal Tract 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
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021590
- Sponsor's protocol ID
- G5-17
- Status last verified
- Dec 2018
- First submitted
- 5 Jan 2017
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori
- ClinicalTrials.gov ID
- NCT03021590
- Acronym / sponsor ID
- G5-17
- Keywords
- Helicobacter pylori, Helicobacter Infections, Proton Pump Inhibitors, sequential therapy, Clarithromycin, Tinidazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Damascus HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 16 Jan 2017 (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.
Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the Eradication of Helicobacter Pylori in Syrian population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clarithromycin :Concomitant Therapy | Experimental | Drug: Clarithromycin 500Mg Oral TabletAmoxicillin 1000 mg Tablets, Clarithromycin 500 mg Tablets , Tinidazole 500 mg Tablets and Esomeprazole 20 mg Capsule each every 12 hours for 14 days all by mouth |
| Levofloxacin :Concomitant Therapy | Active comparator | Drug: Levofloxacin 500Mg Oral TabletLevofloxacin 500 mg Tablets Amoxicillin 1000 mg Tablets,Tinidazole 500 mg Tablets and Esomeprazole 20 mg each every 12 hours for 14 days all by mouth |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods: I-Positive rapid urease test (CLOtest). II-Histologic evidence of H. pylori by modified Giemsa staining. III-Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.
Key exclusion criteria (10 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 |
|---|---|---|
| Clarithromycin 500Mg Oral TabletAlso: Esomeprazole 40Mg Capsule, Amoxicillin 1000Mg Capsule, Tinidazole 500Mg TabletAmoxicillin 1000 mg Tablets every 12 hours , Esomeprazole 20 mg Capsule days all ,Clarithromycin 500 mg Tablets and Tinidazole 500 mg Tablets every 12 hours for 14 days all by mouth | Drug | Clarithromycin :Concomitant Therapy |
| Levofloxacin 500Mg Oral TabletAlso: Esomeprazole 40Mg Capsule, Amoxicillin 1000Mg Capsule, Tinidazole 500Mg TabletAmoxicillin 1000 mg Tablets , Esomeprazole 20 mg Capsule,Levofloxacin 500 mg Tablets and Tinidazole 500 mg Tablets all every 12 hours for 14 days all by mouth | Drug | Levofloxacin :Concomitant Therapy |
Primary outcome
Helicobacter pylori Eradication rate
Time frame: 6 weeks after eradication therapy
Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Clarithromycin 500Mg Oral Tablet and Levofloxacin 500Mg Oral Tablet in people with Helicobacter Pylori Gastrointestinal Tract 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 1 inclusion and 10 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: withdrawn, as of the sponsor's last update on 7 Dec 2018. 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 was withdrawn before enrolling participants, so there are no results.
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 Eradication rate (time frame: 6 weeks after eradication therapy). 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 7 Dec 2018.