Esophagitis Peptic Clinical Trial
— VIEWOfficial title:
A Multi-center, Single-arm, Prospective, Non-interventional Study on Vonoprazan in the Real-world Clinical Practice in China
| Verified date | October 2023 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 3000 |
| Est. completion date | June 27, 2023 |
| Est. primary completion date | June 27, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Must be undergoing treatment with Vonoprazan. 2. Must be at least 18 years old. 3. 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: 1. Are currently enrolled in or plan to participate in any other clinical trials (that is interventional study). 2. Are contraindicated for Vonoprazan according to Product Package Insert. 3. With a known hepatic function impairment, including jaundice. |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Hospital | Beijing | Beijing |
| China | Beijing Tsinghua Changgung Hospital | Beijing | Beijing |
| China | Peking Union Medical College Hospital | Beijing | Beijing |
| China | The First Hospital of Jilin University | Changchun | Jilin |
| China | Changshu No.2 People's Hospital | Changshu | Jiangsu |
| China | Chengdu Third People's Hospital | Chengdu | Sichuan |
| China | West China Hospital, Sichuan University | Chengdu | Sichuan |
| China | Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong |
| China | The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
| China | The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
| China | The Third Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
| China | The Affiliated Hospital of Hangzhou Normal University | Hangzhou | Zhejiang |
| China | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| China | Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang |
| China | Heilongjiang Provincial Hospital (Nanshang) | Harbin | Heilongjiang |
| China | Qilu Hospital of Shandong University | Jinan | Shandong |
| China | Shandong Provincial Hospital | Jinan | Shandong |
| China | Lanzhou University Second Hospital | Lanzhou | Gansu |
| China | Jiangxi Provincial People's Hospital | Nanchang | Jiangxi |
| China | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
| China | Jiangsu Province Hospital | Nanjing | Jiangsu |
| China | Nanjing First Hospital | Nanjing | Jiangsu |
| China | The Affiliated Drum Tower Hospital of Nanjing University | Nanjing | Jiangsu |
| China | The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
| China | The Affiliated Hospital of Medical School of Ningbo University | Ningbo | Zhejiang |
| China | Qilu Hospital of Shandong University (Qingdao) | Qingdao | Shandong |
| China | Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
| China | The First Hospital of China Medical University | Shenyang | Liaoning |
| China | Huazhong University of Science and Technology Union Shenzhen Hospital | Shenzhen | Guangdong |
| China | General Hospital of Tianjin | Tianjing | Tianjin |
| China | Weifang Peoples Hospital | Weifang | Shandong |
| China | The Second Affiliated Hospital of Wenzhou Medical College | Wenzhou | Zhejiang |
| China | Wenzhou Central Hospital | Wenzhou | Zhejiang |
| China | Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei |
| China | Union Hospital, Tongji Medical College of Huazhong University of Science & Technology | Wuhan | Hubei |
| China | Yantai Affiliated Hospital of Binzhou Medical College | Yantai | Shandong |
| China | The Fourth Affiliated Hospital Zhejiang University School of Medicine | Yiwu | Zhejiang |
| China | Yongchuan Hospital of Chongqing Medical University | Yongchuan | Chongqing |
| China | Henan Provincial Peoples Hospital | Zhengzhou | Henan |
| China | Zhuhai People's Hospital | Zhuhai | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Reporting one or More AEs | Up to Week 10 | ||
| Primary | Percentage of Participants Reporting one or More SAEs | Up to Week 10 | ||
| Primary | Percentage of Participants Reporting one or More ADRs | ADRs refers to AE related to administered drug. | Up to Week 10 | |
| Secondary | Percentage of Participants with Endoscopic Healing of Reflux Esophagitis (RE) During 4-week Treatment | 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). | Baseline up to Week 4 | |
| Secondary | Percentage of Participants with Endoscopic Healing of RE During 8-week Treatment | 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). | Baseline up to Week 8 | |
| Secondary | Percentage of RE Participants Without Gastroesophageal Reflux Disease (GERD) Typical Symptoms | 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. | Baseline and Week 4 | |
| Secondary | Percentage of Participants With Heartburn at Baseline Achieving Complete Heartburn Symptom Relief During the First Week of Treatment | 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%. | Baseline up to Week 1 | |
| Secondary | Percentage of Participants with Night Time Heartburn at Baseline Achieving Complete Night Time Heartburn Symptom Relief During the First Week of Treatment | 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%. | Baseline up to Week 1 | |
| Secondary | Percentage of Participants With Acid Regurgitation at Baseline Achieving Complete Acid Regurgitation Symptom Relief During the First Week of Treatment | 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%. | Baseline up to Week 1 | |
| Secondary | 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 | 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%. | Baseline up to Week 1 | |
| Secondary | Change from Baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score at 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. | Baseline up to Week 4 |