Helicobacter PyloriPhase 1NCT04753437
A Study of Vonoprazan in Adults With Helicobacter Pylori
A Phase 1 study testing Clarithromycin, Amoxicillin and Bismuth potassium citrate in people with Helicobacter Pylori, run by Takeda at 1 site in China.
Trial summary
Helicobacter Pylori (H Pylori) is a bug found in the digestive system. It can cause soreness and redness in the stomach (gastritis). It can also cause ulcers in the stomach and other parts of the digestive system. Vonoprazan is a medicine to treat people with H Pylori. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Helicobacter Pylori
- What is being tested?
- Clarithromycin, Amoxicillin and Bismuth potassium citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2021to 5 Nov 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HP positive participants.
- Weighs at least 50 kilogram (kg) and has a body mass index between greater than (>) 18 and less than equal to (<=) 30 kilogram per square meter (kg/m^2), inclusive, at screening and Day -1 (check-in).
- Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up call on Day 17.
Who cannot join
- Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular consumption of 21 units or more units per week) at any time prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study (up to Day 17).
- Has history of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome, or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.
- Has undergone therapeutic upper gastrointestinal endoscopic therapy (example, endoscopic hemostasis or excision including biopsy) within 30 days prior to Screening.
- Has undergone major surgical procedures within the past 1 month or are scheduled to undergo surgical procedures that may affect gastric acid secretion (example, abdominal surgery, vagotomy, or craniotomy).
- Has a history of cancer, except basal cell carcinoma or Stage 1 squamous cell carcinoma of the skin that has been in remission for at least 5 years prior to Day 1.
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- Has a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody/antigen at Screening.
- Has used nicotine-containing products (including but not limited to cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum) within 6 weeks prior to Check-in. Cotinine test is positive at Screening or Check-in.
- Has poor peripheral venous access.
- Has donated or lost 450 milliliter (mL) or more of his blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1.
- Has abnormal Screening or Check-in laboratory values that suggest a clinically significant underlying disease or subject with the following laboratory abnormalities: alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin > the upper limit of normal (ULN).
- Has reduced renal function assessed by having an estimated glomerular filtration rate <90 milliliter per min per 1.73 square meter (mL/min/1.73 m^2) (as estimated by Chronic Kidney Disease-Epidemology Collaboration) at Screening or Check-in.
Trial locations and contacts
1 site in 1 country.
China1 site
West China Hospital, Sichuan University, Phase I Unit
Chengdu, Sichuan, 610041
About this study
Official title: A Phase 1, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Quadruple Therapy (Bismuth, Clarithromycin, and Amoxicillin) With Vonoprazan Versus Quadruple Therapy With Esomeprazole
Helicobacter Pylori (H Pylori) is a bug found in the digestive system. It can cause soreness and redness in the stomach (gastritis). It can also cause ulcers in the stomach and other parts of the digestive system. Vonoprazan is a medicine to treat people with H Pylori. It is taken together with other medicines to fight infections caused by H Pylori.
The main aim of this study is to learn if vonoprazan changes how the other medicines are processed by the body. It will be compared with another medicine called esomeprazole. Other aims are to check for side effects from the study medicines.
Read more
At the first visit, the study doctor will check who can take part. Participants who take part will be picked for 1 of 2 treatments by chance.
- Vonoprazan taken with bismuth, clarithromycin, and amoxicillin
- Esomeprazole taken with bismuth, clarithromycin, and amoxicillin
Both treatments will last for 14 days. Participants will stay in the clinic throughout their treatment.
After treatment, the clinic staff will telephone the participants 2 days later for a check-up. The participants will visit the clinic 4 weeks later for a final check-up.
Read the detailed description
This is a study in healthy participants with Helicobacter pylori (HP positive) to evaluate the safety, tolerability and PK of a quadruple therapy with bismuth, clarithromycin, amoxicillin, and vonoprazan versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and esomeprazole.
The treatment phase consists of quadruple therapy twice daily (BID) with bismuth potassium citrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and vonoprazan (20 mg) (Group B) or quadruple therapy BID with bismuth potassium citrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg) (Group A) from Days 1 to 14. Participants will be discharged on Day 15 after all procedures have been performed.
This single-center will be conducted in China. Participants will remain confined to the study site from check-in (Day -1) through Day 15 and will followed up through call on Day 17 and return on Day 42 for a follow-up assessment.
- Conditions
- Helicobacter Pylori
- Being tested
- Clarithromycin, Amoxicillin, Bismuth potassium citrate, Esomeprazole, Vonoprazan
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
Clarithromycin tablets.
AmoxicillinDrug
Amoxicillin capsules.
Bismuth potassium citrateDrug
Bismuth potassium citrate tablets.
EsomeprazoleDrug
Esomeprazole tablets.
VonoprazanDrug
Also called TAK-438
Vonoprazan tablets.
| Study group | Role | What they receive |
|---|---|---|
| Clarithromycin + Amoxicillin + Bismuth + Vonoprazan | Experimental | Clarithromycin 500 milligram (mg), tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14. Receives: Drug: Clarithromycin; Drug: Amoxicillin; Drug: Bismuth potassium citrate; Drug: Vonoprazan |
| Clarithromycin + Amoxicillin + Bismuth + Esomeprazole | Active comparator | Clarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14. Receives: Drug: Clarithromycin; Drug: Amoxicillin; Drug: Bismuth potassium citrate; Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum Observed Plasma Concentration for Bismuth
Measured: Day 14: 0 to 12 hours after the morning dose
AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval τ for Bismuth
Measured: Day 14: 0 to 12 hours after the morning dose
Aeτ: Total Amount of Bismuth Excreted in Urine During a Dosing Interval τ for Bismuth
Measured: Day 14: 0 to 12 hours after the morning dose
Secondary outcomes (2)
Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with an onset that occurs after receiving study drug.
Measured: From the first dose of study drug up to Day 17
Percentage of Participants Who Discontinued Study Drug Due to a Treatment-Emergent Adverse Event (TEAE)
Measured: From the first dose of study drug up to Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start6 Apr 2021
- Primary completion27 Sep 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Helicobacter PyloriStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753437
- Sponsor's protocol ID
- Vonoprazan-1001
- Other IDs
- U1111-1257-0258
- Status last verified
- Oct 2022
- First submitted
- 12 Feb 2021
- Last updated
- 31 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Quadruple Therapy (Bismuth, Clarithromycin, and Amoxicillin) With Vonoprazan Versus Quadruple Therapy With Esomeprazole
- ClinicalTrials.gov ID
- NCT04753437
- Acronym / sponsor ID
- Vonoprazan-1001
- Conditions
- Helicobacter Pylori
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 27 Sep 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Posted 31 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Helicobacter Pylori (H Pylori) is a bug found in the digestive system. It can cause soreness and redness in the stomach (gastritis). It can also cause ulcers in the stomach and other parts of the digestive system. Vonoprazan is a medicine to treat people with H Pylori. It is taken together with other medicines to fight infections caused by H Pylori.
The main aim of this study is to learn if vonoprazan changes how the other medicines are processed by the body. It will be compared with another medicine called esomeprazole. Other aims are to check for side effects from the study medicines.
At the first visit, the study doctor will check who can take part. Participants who take part will be picked for 1 of 2 treatments by chance.
- Vonoprazan taken with bismuth, clarithromycin, and amoxicillin
- Esomeprazole taken with bismuth, clarithromycin, and amoxicillin
Both treatments will last for 14 days. Participants will stay in the clinic throughout their treatment.
After treatment, the clinic staff will telephone the participants 2 days later for a check-up. The participants will visit the clinic 4 weeks later for a final check-up.
Detailed description
This is a study in healthy participants with Helicobacter pylori (HP positive) to evaluate the safety, tolerability and PK of a quadruple therapy with bismuth, clarithromycin, amoxicillin, and vonoprazan versus quadruple therapy with bismuth, clarithromycin, amoxicillin, and esomeprazole.
The treatment phase consists of quadruple therapy twice daily (BID) with bismuth potassium citrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and vonoprazan (20 mg) (Group B) or quadruple therapy BID with bismuth potassium citrate (600 mg), clarithromycin (500 mg), amoxicillin (1000 mg), and esomeprazole (20 mg) (Group A) from Days 1 to 14. Participants will be discharged on Day 15 after all procedures have been performed.
This single-center will be conducted in China. Participants will remain confined to the study site from check-in (Day -1) through Day 15 and will followed up through call on Day 17 and return on Day 42 for a follow-up assessment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clarithromycin + Amoxicillin + Bismuth + Vonoprazan | Experimental | Drug: Clarithromycin, Drug: Amoxicillin, Drug: Bismuth potassium citrate, Drug: VonoprazanClarithromycin 500 milligram (mg), tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and vonoprazan 20 mg, tablets, orally, BID on Days 1 to 14. |
| Clarithromycin + Amoxicillin + Bismuth + Esomeprazole | Active comparator | Drug: Clarithromycin, Drug: Amoxicillin, Drug: Bismuth potassium citrate, Drug: EsomeprazoleClarithromycin 500 mg, tablets, orally, BID, along with amoxicillin 1000 mg, capsules, orally, BID, bismuth potassium citrate 600 mg, capsules, orally, BID, and esomeprazole 20 mg, tablets, orally, BID on Days 1 to 14. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- HP positive participants.
- Weighs at least 50 kilogram (kg) and has a body mass index between greater than (>) 18 and less than equal to (<=) 30 kilogram per square meter (kg/m^2), inclusive, at screening and Day -1 (check-in).
- Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up call on Day 17.
Key exclusion criteria (12 listed)
- Has a positive urine drug result for drugs of abuse at Screening or Check-in (Day -1).
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular consumption of 21 units or more units per week) at any time prior to the Screening Visit or is unwilling to agree to abstain from alcohol and drugs throughout the study (up to Day 17).
- Has history of gastroesophageal reflux disease (GERD), symptomatic GERD, erosive esophagitis, duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison syndrome, or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.
- Has undergone therapeutic upper gastrointestinal endoscopic therapy (example, endoscopic hemostasis or excision including biopsy) within 30 days prior to Screening.
- Has undergone major surgical procedures within the past 1 month or are scheduled to undergo surgical procedures that may affect gastric acid secretion (example, abdominal surgery, vagotomy, or craniotomy).
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 |
|---|---|---|
| ClarithromycinClarithromycin tablets. | Drug | Clarithromycin + Amoxicillin + Bismuth + Esomeprazole, Clarithromycin + Amoxicillin + Bismuth + Vonoprazan |
| AmoxicillinAmoxicillin capsules. | Drug | Clarithromycin + Amoxicillin + Bismuth + Esomeprazole, Clarithromycin + Amoxicillin + Bismuth + Vonoprazan |
| Bismuth potassium citrateBismuth potassium citrate tablets. | Drug | Clarithromycin + Amoxicillin + Bismuth + Esomeprazole, Clarithromycin + Amoxicillin + Bismuth + Vonoprazan |
| EsomeprazoleEsomeprazole tablets. | Drug | Clarithromycin + Amoxicillin + Bismuth + Esomeprazole |
| VonoprazanAlso: TAK-438Vonoprazan tablets. | Drug | Clarithromycin + Amoxicillin + Bismuth + Vonoprazan |
Primary outcome
Cmax: Maximum Observed Plasma Concentration for Bismuth
Time frame: Day 14: 0 to 12 hours after the morning dose
AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval τ for Bismuth
Time frame: Day 14: 0 to 12 hours after the morning dose
Aeτ: Total Amount of Bismuth Excreted in Urine During a Dosing Interval τ for Bismuth
Time frame: Day 14: 0 to 12 hours after the morning dose
2 secondary outcomes
Percentage of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: From the first dose of study drug up to Day 17
Percentage of Participants Who Discontinued Study Drug Due to a Treatment-Emergent Adverse Event (TEAE)
Time frame: From the first dose of study drug up to Day 17
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Medical Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Clarithromycin, Amoxicillin and Bismuth potassium citrate in people with Helicobacter Pylori, run by Takeda at 1 site in China.
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 3 inclusion and 12 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 31 Aug 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cmax: Maximum Observed Plasma Concentration for Bismuth (time frame: Day 14: 0 to 12 hours after the morning dose). The study lists 3 primary outcomes in all. 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 31 Aug 2023.