Helicobacter Pylori
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to evaluate the efficacy of helicobacter pylori (HP) eradication with bismuth-containing quadruple therapy with vonoprazan versus esomeprazole in all HP-positive participants.
Detailed description
The drug being tested in this study is called vonoprazan (TAK-438). Vonoprazan is being tested to treat people who have helicobacter pylori infection. The study is planned to enroll 425 patients at the beginning and will enroll a maximum of approximately 510 patients based on the interim analysis results. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): Vonoprazan 20 mg Esomeprazole 20 mg All participants will be asked to take one tablet in combination with bismuth containing quadruple therapy (amoxicillin, clarithromycin and bismuth potassium citrate) twice at the same time each day throughout the study. This multi-center trial will be conducted in China. The overall time to participate in this study is 10 weeks. Participants will make multiple visits to the clinic, and 28 days after last dose of study drug for a follow-up assessment.
Interventions
DRUGVonoprazan
Vonoprazan Tablets
DRUGAmoxicillin
Amoxicillin Capsules
DRUGClarithromycin
Clarithromycin Tablets
DRUGBismuth Potassium citrate
Bismuth Potassium citrate
DRUGEsomeprazole
Esomeprazole Tablets
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Helicobacter pylori (HP)-positive participants as determined by \^13C-urea breath test (\^13C-UBT) at the start of the study (Visit 1 \[screening\]) and who require HP eradication in Physician judgment.
Exclusion criteria
1. Participant had any of the following conditions at the start of the study (Visit 1, screening): acute upper gastrointestinal bleeding, active gastric ulcer (GU) or duodenal ulcer (DU) characterized by defective mucos with white coating (with or without adherent blood clots) 3 mm or more in size, acute gastric mucosal lesion (AGML), or acute duodenal mucosal lesion (ADML). However, participants with gastritis, gastric or duodenal erosion are permitted to participate. 2. Participants with Zollinger-Ellison syndrome or gastric acid hypersecretion or those with a history of gastric acid hypersecretion. 3. Participant has a history of malignancy or was treated for malignancy within 5 years before the start of the screening visit (the participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ). 4. Participant has a known acquired immunodeficiency syndrome or hepatitis infection, including hepatitis virus carriers (hepatitis B surface antigen \[HBsAg\] or hepatitis C virus \[HCV\]- antibody-positive).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment | Week 4 post-treatment | HP infection status was determined by \^13C Urea Breath Test (\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The percentages are rounded off to report the nearest ten. |
Countries
China
Participant flow
Recruitment details
Participants took part in the study at 29 investigative sites in China from 30 April 2020 to 25 November 2021.
Pre-assignment details
Helicobacter pylori (HP) positive participants were enrolled and randomized to one of the two treatment groups to either receive quadruple therapy with amoxicillin, clarithromycin, bismuth, and vonoprazan versus quadruple therapy with amoxicillin, clarithromycin, bismuth, and esomeprazole.
Participants by arm
| Arm | Count |
|---|---|
| Vonoprazan 20 mg Vonoprazan 20 mg, tablets, orally, BID given in combination with bismuth-containing quadruple therapy (amoxicillin 1 g capsules, clarithromycin 500 mg tablets, and bismuth potassium citrate 600 mg capsules) orally, BID for 2 weeks. | 256 |
| Esomeprazole 20 mg Esomeprazole 20 mg, tablets, orally, BID given in combination with bismuth-containing quadruple therapy (amoxicillin 1 g capsules, clarithromycin 500 mg tablets, and bismuth potassium citrate 600 mg capsules) orally, BID for 2 weeks. | 254 |
| Total | 510 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Reason not Specified | 1 | 0 |
| Overall Study | Voluntary Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Vonoprazan 20 mg | Total | Esomeprazole 20 mg |
|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 12.29 | 38.9 years STANDARD_DEVIATION 12.21 | 38.3 years STANDARD_DEVIATION 12.13 |
| Body Mass Index (BMI) | 22.66 kg/m^2 STANDARD_DEVIATION 2.913 | 22.63 kg/m^2 STANDARD_DEVIATION 2.823 | 22.61 kg/m^2 STANDARD_DEVIATION 2.735 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 256 Participants | 510 Participants | 254 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 164.9 cm STANDARD_DEVIATION 8.23 | 164.6 cm STANDARD_DEVIATION 7.97 | 164.3 cm STANDARD_DEVIATION 7.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 256 Participants | 510 Participants | 254 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 256 Participants | 510 Participants | 254 Participants |
| Sex: Female, Male Female | 151 Participants | 315 Participants | 164 Participants |
| Sex: Female, Male Male | 105 Participants | 195 Participants | 90 Participants |
| Weight | 61.90 kg STANDARD_DEVIATION 10.579 | 61.53 kg STANDARD_DEVIATION 10.087 | 61.15 kg STANDARD_DEVIATION 9.568 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 256 | 0 / 254 |
| other Total, other adverse events | 110 / 256 | 91 / 254 |
| serious Total, serious adverse events | 3 / 256 | 5 / 254 |
Outcome results
Primary
Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment
HP infection status was determined by \^13C Urea Breath Test (\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory. The percentages are rounded off to report the nearest ten.
Time frame: Week 4 post-treatment
Population: FAS included all randomized participants who received at least 1 dose of the study drug. Overall number analyzed are the number of participants who had available HP eradication status determined by \^13C-UBT at Week 4 post-treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vonoprazan 20 mg | Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment | 86.8 percentage of participants |
| Esomeprazole 20 mg | Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post-Treatment | 86.7 percentage of participants |
p-value: =0.000995% CI: [-5.95, 6.17]Farrington and Manning Test