H Pylori EradicationPhase 4NCT03087162
Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori
A Phase 4 study testing Dexlansoprazole 60 mg once daily in people with H Pylori Eradication, run by Ramathibodi Hospital at 1 site in Thailand.
Trial summary
New drug regimen for Helicobacter pylori eradication, the investigators compare once daily dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- H Pylori Eradication
- What is being tested?
- Dexlansoprazole 60 mg once daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2017to 1 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 year-patient
- Diagnosed as positive Helicobacter Pylori testing by any of the following methods:
- Rapid urease test or Histology
- Inform consent
Who cannot join
- Previous history of Helicobacter pylori eradication
- Contraindications or allergic reactions to the study drugs
- Previous gastric surgery or advanced gastric cancer or other malignancy or other severe concurrent diseases
- Decompensated Liver cirrhosis or chronic kidney disease (GFR< 30)
- Mental disorders or alcohol or drug addiction
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Once Daily Dose Dexlansoprazole Levofloxacin Based Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Controlled Study
New drug regimen for Helicobacter pylori eradication, the investigators compare once daily dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.
Read the detailed description
Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication of Helicobacter pylori infection.
- Conditions
- H Pylori Eradication
- Being tested
- Dexlansoprazole 60 mg once daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexlansoprazole 60 mg once dailyDrug
Also called dexilant
Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm
| Study group | Role | What they receive |
|---|---|---|
| Once daily dose dexlansoprazole | Experimental | Group 1 Dexlansoprazole 60 mg by oral once daily for 14 days (Levofloxacin 500 mg by oral once daily for 14 days Amoxicillin 1000 mg by oral bid for 14 days Bismuth 1048 mg by oral bid for 14 days) Receives: Drug: Dexlansoprazole 60 mg once daily |
| Twice daily dose dexlansoprazole | Active comparator | Group 2 Dexlansoprazole 60 mg oral bid 14 Days (Levofloxacin 500 mg od oral 14 Days Amoxicillin 1000 mg bid oral 14 Days Bismuth 1048 mg bid oral 14 Days) Receives: Drug: Dexlansoprazole 60 mg once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate (percentage)
Compare eradication rate of helicobacter pylori between 2 groups
Measured: Jan17-Nov17, Total 11 months
Secondary outcomes (2)
To compare drug compliance
The investigators measure drug compliance between 2 groups, The investigators consider more than 85% of taking medications is a good compliance.
Measured: jan17-Nov17, Total 11 months
To compare drug adverse event
The investigators measure adverse events as
- Nausea/Vomiting
- Abdominal pain/Abdominal discomfort/Abdominal Bloating
- Diarrhea/ Constipation
- Taste distortions
- Headache/Dizziness
- Rash/Itching/Drug allergy, Any symptoms occur new onset during taking medications, The investigators consider as an adverse events of an experiment.
Measured: jan17-Nov17, Total 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start1 Jan 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H Pylori EradicationStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parin siriwat, Ramathibodi Hospital
- Investigators
- Akrawit Pulsombat, Doctor, Study director, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087162
- Sponsor's protocol ID
- Psiriwat
- Status last verified
- Apr 2018
- First submitted
- 9 Feb 2017
- Last updated
- 3 Apr 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 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once Daily Dose Dexlansoprazole Levofloxacin Based Quadruple Therapy for Helicobacter Pylori Eradication: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03087162
- Acronym / sponsor ID
- Psiriwat
- Conditions
- H Pylori Eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 22 Mar 2017 (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.
New drug regimen for Helicobacter pylori eradication, the investigators compare once daily dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.
Detailed description
Once daily dose dexlansoprazole should be non inferior to twice daily dose in the eradication of Helicobacter pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once daily dose dexlansoprazole | Experimental | Drug: Dexlansoprazole 60 mg once dailyGroup 1 Dexlansoprazole 60 mg by oral once daily for 14 days (Levofloxacin 500 mg by oral once daily for 14 days Amoxicillin 1000 mg by oral bid for 14 days Bismuth 1048 mg by oral bid for 14 days) |
| Twice daily dose dexlansoprazole | Active comparator | Drug: Dexlansoprazole 60 mg once dailyGroup 2 Dexlansoprazole 60 mg oral bid 14 Days (Levofloxacin 500 mg od oral 14 Days Amoxicillin 1000 mg bid oral 14 Days Bismuth 1048 mg bid oral 14 Days) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 year-patient
- Diagnosed as positive Helicobacter Pylori testing by any of the following methods:
- Inform consent
Key exclusion criteria (6 listed)
- Previous history of Helicobacter pylori eradication
- Contraindications or allergic reactions to the study drugs
- Previous gastric surgery or advanced gastric cancer or other malignancy or other severe concurrent diseases
- Decompensated Liver cirrhosis or chronic kidney disease (GFR< 30)
- Mental disorders or alcohol or drug addiction
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 |
|---|---|---|
| Dexlansoprazole 60 mg once dailyAlso: dexilantOnce daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm | Drug | Once daily dose dexlansoprazole, Twice daily dose dexlansoprazole |
Primary outcome
Eradication rate (percentage)
Time frame: Jan17-Nov17, Total 11 months
Compare eradication rate of helicobacter pylori between 2 groups
2 secondary outcomes
To compare drug compliance
Time frame: jan17-Nov17, Total 11 months
To compare drug adverse event
Time frame: jan17-Nov17, Total 11 months
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 3 Apr 2018.
- Individual participant dataSharing planned: Undecided
Related trials for H Pylori Eradication
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Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
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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.
Akrawit Pulsombat, Doctor study director
Ramathibodi 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 Dexlansoprazole 60 mg once daily in people with H Pylori Eradication, run by Ramathibodi Hospital at 1 site in Thailand.
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 6 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 3 Apr 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 Thailand. 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 (percentage) (time frame: Jan17-Nov17, Total 11 months). 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 3 Apr 2018.