Helicobacter Pylori EradicationPhase 3P-CABsNCT06101420
Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication
A Phase 3 study testing Vonoprazan in people with Helicobacter Pylori Eradication, run by Ain Shams University at 1 site in Egypt.
Trial summary
This trial assessed the efficacy of potassium competetor acid blocker (P-CAB) in the eradication of H.pylori Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Eradication
- What is being tested?
- Vonoprazan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jun 2023
- 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
- Age above 18 years of both genders.
- Symptomatic patients who has been diagnosed to be H. pylori positive stool by using H. pylori stool antigen test.
- Patients who did not receive H. pylori eradication regimens before were included in group I of the study (First line eradication regimen).
- Patients who received only one eradication regimen before were included in group II of the study (Second line eradication regimen).
- Patients signing an informed consent.
Who cannot join
- Patients refusing to sign an informed consent.
- Patients who were on PPIs, P-CABs and/or antibiotics starting one month before inclusion in the study .
- Patients who have chronic debilitating and advanced systemic diseases.
- Patients treated with low dose aspirin and/or non-steroidal anti-inflammatory drugs for a long time.
- Any lactating or pregnant female.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Potassium Competitive Acid Blockers (P-CABs) Versus Proton Pump Inhibitors (PPIs) in the First and the Second Lines Eradication Regimens for H. Pylori in Egyptian Patients
This trial assessed the efficacy of potassium competetor acid blocker (P-CAB) in the eradication of H.pylori
Read the detailed description
The aim of this study is to compare the effectiveness of Vonaprazan based therapy vs.Proton Pump Inhibitor (PPI)based therapy for the eradication of H.Pylori infection in treatment naive and treatment experienced Egyptian patients.This prospective, non- randomized, controlled study was conducted on symptomatic patients admitted at Tropical Medicine Department at Ain Shams University Hospitals and those presenting at outpatient clinic. The study was conducted in the period from the 1st of January 2022 to the 1st of June 2023.
- Conditions
- Helicobacter Pylori Eradication
- Being tested
- Vonoprazan
- Keywords
- P-CABs, Vonoprazan, H.pylori eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VonoprazanDrug
Also called Clarithromycin, Amoxycillin, Esomeprazole, Levofloxacin
Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Vonoprazn Triple Therapy Arm | Experimental | Fifty eight participants.The patients received (Clarithromycin 500 mg tablets twice daily[BID]+ Amoxicillin 1gm capsules BID + Vonoprazan 20 mg tablets BID) for 14 days Receives: Drug: Vonoprazan |
| Arm 2 Proton Pump Inhibitor Triple Therapy Arm | Active comparator | Fifty eight participants.The patients received the classic triple therapy (Clarithromycin 500 mg tablets BID + Amoxicillin 1gm capsules BID + Esomeprazole 20 mg tablets BID) for 14 days Receives: Drug: Vonoprazan |
| Arm 3 Vonoprazan Quadruple Therapy Arm | Experimental | Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets once daily[OD] + Vonoprazan 20mg tablets BID + Nitazoxanide 500mg tablets BID +Doxycycline 100mg capsules OD) for 14 days. Receives: Drug: Vonoprazan |
| Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm | Active comparator | Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets OD + Esomeprazole 20mg tablets BID + Nitazoxanide 500 mg tablets BID +Doxycycline 100mg capsules OD) for 14 days Receives: Drug: Vonoprazan |
What is being measured
The primary outcome is the main question the study is designed to answer.
H.pylori eradication
The rate of the patients who achieved H.pylori eradication as measured by negative H.Pylori stool antigen test in the four arms of the study was reported.
Measured: six weeks
Secondary outcomes (1)
Safety of Vonoprazan use
The number of patients who reported minor and major treatment connected adverse events in the four arms of the study was reported.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start1 Jan 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori EradicationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reda Elwakil, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101420
- Sponsor's protocol ID
- 111954
- Acronym
- P-CABs
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Potassium Competitive Acid Blockers (P-CABs) Versus Proton Pump Inhibitors (PPIs) in the First and the Second Lines Eradication Regimens for H. Pylori in Egyptian Patients
- ClinicalTrials.gov ID
- NCT06101420
- Acronym / sponsor ID
- P-CABs / 111954
- Conditions
- Helicobacter Pylori Eradication
- Keywords
- P-CABs, Vonoprazan, H.pylori eradication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 26 Oct 2023 (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.
This trial assessed the efficacy of potassium competetor acid blocker (P-CAB) in the eradication of H.pylori
Detailed description
The aim of this study is to compare the effectiveness of Vonaprazan based therapy vs.Proton Pump Inhibitor (PPI)based therapy for the eradication of H.Pylori infection in treatment naive and treatment experienced Egyptian patients.This prospective, non- randomized, controlled study was conducted on symptomatic patients admitted at Tropical Medicine Department at Ain Shams University Hospitals and those presenting at outpatient clinic. The study was conducted in the period from the 1st of January 2022 to the 1st of June 2023.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Vonoprazn Triple Therapy Arm | Experimental | Drug: VonoprazanFifty eight participants.The patients received (Clarithromycin 500 mg tablets twice daily[BID]+ Amoxicillin 1gm capsules BID + Vonoprazan 20 mg tablets BID) for 14 days |
| Arm 2 Proton Pump Inhibitor Triple Therapy Arm | Active comparator | Drug: VonoprazanFifty eight participants.The patients received the classic triple therapy (Clarithromycin 500 mg tablets BID + Amoxicillin 1gm capsules BID + Esomeprazole 20 mg tablets BID) for 14 days |
| Arm 3 Vonoprazan Quadruple Therapy Arm | Experimental | Drug: VonoprazanFifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets once daily[OD] + Vonoprazan 20mg tablets BID + Nitazoxanide 500mg tablets BID +Doxycycline 100mg capsules OD) for 14 days. |
| Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm | Active comparator | Drug: VonoprazanFifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets OD + Esomeprazole 20mg tablets BID + Nitazoxanide 500 mg tablets BID +Doxycycline 100mg capsules OD) 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 (5 listed)
- Age above 18 years of both genders.
- Symptomatic patients who has been diagnosed to be H. pylori positive stool by using H. pylori stool antigen test.
- Patients who did not receive H. pylori eradication regimens before were included in group I of the study (First line eradication regimen).
- Patients who received only one eradication regimen before were included in group II of the study (Second line eradication regimen).
- Patients signing an informed consent.
Key exclusion criteria (5 listed)
- Patients refusing to sign an informed consent.
- Patients who were on PPIs, P-CABs and/or antibiotics starting one month before inclusion in the study .
- Patients who have chronic debilitating and advanced systemic diseases.
- Patients treated with low dose aspirin and/or non-steroidal anti-inflammatory drugs for a long time.
- Any lactating or pregnant female.
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 |
|---|---|---|
| VonoprazanAlso: Clarithromycin, Amoxycillin, Esomeprazole, LevofloxacinVenoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily | Drug | Arm 1 Vonoprazn Triple Therapy Arm, Arm 2 Proton Pump Inhibitor Triple Therapy Arm, Arm 3 Vonoprazan Quadruple Therapy Arm, Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm |
Primary outcome
H.pylori eradication
Time frame: six weeks
The rate of the patients who achieved H.pylori eradication as measured by negative H.Pylori stool antigen test in the four arms of the study was reported.
1 secondary outcome
Safety of Vonoprazan use
Time frame: six 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 26 Oct 2023.
- 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.
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 3 study testing Vonoprazan in people with Helicobacter Pylori Eradication, run by Ain Shams University at 1 site in Egypt.
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 5 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 26 Oct 2023. 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 Egypt. 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?
H.pylori eradication (time frame: six 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 26 Oct 2023.