A Multicenter, Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Fixed Dose Combination of Sodium Alginate IP 1000 mg and Potassium hydrogen carbonate Ph EUR 200 mg Oral Suspension in Patients with Gastroesophageal Reflux Disease (GERD)
概览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 发起方
- Ms Abbott India Limited
- 入组人数
- 320
- 试验地点
- 4
- 主要终点
- Patients with highly restricted salt/sodium diet e.g., cases of congestive cardiac failure, renal impairment, hypertension, and edema states.
概览
简要总结
This is a multicenter post-marketing surveillance study to evaluate the safety and effectiveness of the Fixed dose combination (FDC) of Sodium Alginate IP 1000 mg and Potassium hydrogen carbonate Ph EUR 200 mg oral suspension in patients with GERD. Approximately 320 patients suffering with GERD who have been prescribed the FDC oral suspension as per the approved prescribing information in accordance with clinical practice and are willing to sign the patient authorization form (PAF), will be eligible to participate in the study.
The study will involve clinical assessments of patients at baseline visit (Day 1, Visit 1) and at or closest to 7 days after treatment with the FDC oral suspension (Visit 2). The FDC oral suspension will be prescribed by the investigator as a part of routine clinical practice, independent of the decision to include the patient in the study.
The FDC oral suspension will not be provided by the Sponsor. Each patient will take the FDC oral suspension (5-10 mL after meals and at bedtime) as per the prescribing information of the FDC for 7 days. A diary will be provided to the patients to record their clinical symptoms. If the clinical symptoms do not improve after 7 days, the clinical situation will be reviewed by the investigator.
研究设计
- 研究类型
- Pms
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients above 18 years and up to 60 years of age.
- •Patients who are suffering with GERD are prescribed the FDC oral suspension as per the approved prescribing information in accordance with clinical practice.
- •Patients willing to sign patient authorization form (PAF).
排除标准
- •Patients with highly restricted salt/sodium diet e.g., cases of congestive cardiac failure, renal impairment, hypertension, and edema states.
- •Patients of hypercalcemia, nephrocalcinosis, and recurrent calcium containing renal calculi.
- •Patients with known or suspected hypersensitivity to the active substances or any of the excipients; or suffering from any other conditions or diseases that an investigator considers as inappropriate to enter the study as per the approved prescribing information.
- •Patients with highly restricted potassium diet.
- •Patients taking any medications which might interfere with the action of the FDC oral suspension prior to the start of the study.
- •Female patients who are pregnant or are nursing mothers.
- •Patients who are determined to be at risk of COVID-19.
结局指标
主要结局
Patients with highly restricted salt/sodium diet e.g., cases of congestive cardiac failure, renal impairment, hypertension, and edema states.
时间窗: 7 days
Patients of hypercalcemia, nephrocalcinosis, and recurrent calcium containing renal calculi.
时间窗: 7 days
Patients with highly restricted potassium diet.
时间窗: 7 days
Patients taking any medications which might interfere with the action of the FDC oral suspension prior to the start of the study.
时间窗: 7 days
Patients with known or suspected hypersensitivity to the active substances or any of the excipients; or suffering from any other conditions or diseases that an investigator considers as inappropriate to enter the study as per the approved prescribing information.
时间窗: 7 days
Female patients who are pregnant or are nursing mothers.
时间窗: 7 days
Patients who are determined to be at risk of COVID-19
时间窗: 7 days
次要结局
- Percentage of patients achieving adequate heartburn or regurgitation relief after 7 days of treatment on following 4-point scale-(0 = none (no symptom))
研究者
Dr Shivani Acharya
Abbott India Limited