VIEW: A Study on Vonoprazan in the Real-world Clinical Practice in China
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety of Vonoprazan by assessing all adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) in routine clinical settings in China.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This is a prospective, non-interventional study in Chinese participants with RE who are receiving or will receive the standard treatment of vonoprazan. This study will assess the safety and effectiveness of vonoprazan in the real-world clinical practice.
The study will enroll approximately 3000 participants. The data will be collected through participants' medical records, self-reported questionnaires, and recorded information on symptom via diaries. All the participants will be assigned to a single observational cohort:
• Participants with RE
The multi-center trial will be conducted in China. The standard treatment will be of 4 weeks or it may reach up to 8 weeks if the dosing proves insufficient. All participants will be followed up for additional 2 weeks after the standard treatment. The overall duration of the study will be approximately 10 weeks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants with RE Participants diagnosed with RE who have received 20 milligram (mg) of vonoprazan in routine clinical practice, will be observed prospectively. Data will be collected from participants' medical records, self-reported questionnaires and recorded information on symptom via diaries. |
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Reporting one or More AEs [Up to Week 10]
- Percentage of Participants Reporting one or More SAEs [Up to Week 10]
- Percentage of Participants Reporting one or More ADRs [Up to Week 10]
ADRs refers to AE related to administered drug.
Secondary Outcome Measures
- Percentage of Participants with Endoscopic Healing of Reflux Esophagitis (RE) During 4-week Treatment [Baseline up to Week 4]
Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification Grade O during the treatment phase. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break less than [<] 5 millimeter [mm]), Grade B (Mucosal break greater than or equal to [>=] 5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the esophageal circumference) and Grade D (Mucosal break >=75 percent [%] of the esophageal circumference).
- Percentage of Participants with Endoscopic Healing of RE During 8-week Treatment [Baseline up to Week 8]
Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification Grade O during the treatment phase. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break >=5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the esophageal circumference) and Grade D (Mucosal break >=75% of the esophageal circumference).
- Percentage of RE Participants Without Gastroesophageal Reflux Disease (GERD) Typical Symptoms [Baseline and Week 4]
The severity of participants' GERD symptoms based on the investigator's assessment among all participants will be evaluated at Baseline and Week 4. GERD symptoms will be assessed on a 5-point scale, wherein 1= no symptom, 2= mild, 3= moderate, 4= severe and 5= very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP). The participants without any GERD typical symptoms will be analyzed.
- Percentage of Participants With Heartburn at Baseline Achieving Complete Heartburn Symptom Relief During the First Week of Treatment [Baseline up to Week 1]
The complete relief of heartburn symptom is defined as no such symptom occurred on 7 consecutive days. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete heartburn symptom relief) divided by (the total number of participants) *100%.
- Percentage of Participants with Night Time Heartburn at Baseline Achieving Complete Night Time Heartburn Symptom Relief During the First Week of Treatment [Baseline up to Week 1]
The complete relief of night time heartburn symptoms is defined as no such symptom occurred on 7 consecutive nights. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete night time heartburn symptom relief) divided by (the total number of participants) *100%.
- Percentage of Participants With Acid Regurgitation at Baseline Achieving Complete Acid Regurgitation Symptom Relief During the First Week of Treatment [Baseline up to Week 1]
The complete relief of acid regurgitation symptom is defined as no symptoms of acid regurgitation occurring on 7 consecutive days. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete acid regurgitation symptom relief) divided by (the total number of participants) *100%.
- Percentage of Participants With Night Time Acid Regurgitation Symptom at Baseline Achieving Complete Night Time Acid Regurgitation Symptom Relief During the First Week of Treatment [Baseline up to Week 1]
The complete relief of acid regurgitation symptoms durng night time is defined as no symptoms of acid regurgitation occurring on 7 consecutive nights. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete night time acid regurgitation symptom relief) divided by (the total number of participants) *100%.
- Change from Baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score at Week 4 [Baseline up to Week 4]
GerdQ is a self-completed participant questionnaire that is used to assess whether the following symptoms of RE are improved under treatment: heartburn, regurgitation, stomach pain, nausea, sleep disturbance and use of additional medication due to heartburn/regurgitation. Symptom frequency will be assessed for the week passed using following answers: 0 days, 1 day, 2-3 days, and 4-7 days. Each answer will be assigned a score from 0 to 3 (heartburn, regurgitation, sleep disturbance and use of additional medication due to heartburn/regurgitation) or from 3 to 0 (stomach pain, nausea). Total score will be calculated as a sum of 6 individual scores. GerdQ score was calculated as sum of these scores, giving a total score ranging from 0 to 18. When GerdQ >=8, the participants could be symptom based diagnosed as GERD. Total score of 0 to 2 points= 0% likelihood of GERD; 3 to 7 points= 50% likelihood of GERD; 8 to 10 points= 79% likelihood of GERD; 11 to 18 points= 89% likelihood of GERD.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must be undergoing treatment with Vonoprazan.
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Must be at least 18 years old.
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Provide signed informed consent indicating that they (or a legally acceptable representative) have been informed of all pertinent aspects of the study and are willing to participate.
Exclusion Criteria:
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Are currently enrolled in or plan to participate in any other clinical trials (that is interventional study).
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Are contraindicated for Vonoprazan according to Product Package Insert.
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With a known hepatic function impairment, including jaundice.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China | 510080 |
| 2 | the Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | China | 310009 |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Medical Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Vonoprazan-4007