A Multicenter, Post marketing Surveillance Study to Evaluate the Safety and Effectiveness of Fixed-Dose Combination of Sodium Alginate IP 500 mg, Sodium Bicarbonate 213 mg and Calcium Carbonate IP 325 mg Oral Suspension in Patients with Heartburn and Indigestion.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 4
- 主要终点
- Number and percentage of patients with adverse drug reactions (ADRs) and/or Other Pharmacovigilance- Relevant Information (OPRIs)
研究概览
简要总结
This multicenter post marketing surveillance study has been planned to assess the safety and effectiveness of FDC of Sodium alginate IP 500 mg, Sodium bicarbonate IP 213 mg and Calcium carbonate IP 325 mg per 10mL oral suspension in the treatment of patients (aged ≥18 years) with heartburn and indigestion as per the recommendations by the Indian Health Authorities. In this protocol henceforth FDC is referred as FDC of Sodium alginate IP 500 mg, Sodium bicarbonate IP 213 mg and Calcium carbonate IP 325 mg per 10mL oral suspension.
The total study duration will be approximately 12-14 months (including enrolment period and 7 days of study treatment).
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •A patient will be considered eligible for inclusion in the study if he/she fulfils the following criteria: 1.Male and female patients ≥18 years and up to 60 years of age.
- •2.Patients diagnosed with heartburn and indigestion who have been prescribed the FDC oral suspension as per the approved prescribing information in accordance with clinical practice.
- •3.Patients willing to sign patient authorization form (PAF).
排除标准
- •1.Patients will not be considered eligible for inclusion in this study if they meet any of the following criteria: 2.Patients with highly restricted salt/sodium diet e.g., cases of congestive cardiac failure, renal impairment, hypertension, and edema states.
- •3.Patients with history or ongoing illness of hypercalcemia, nephrocalcinosis, and recurrent calcium containing renal calculi.
- •4.Patients with history of 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.
- •5.Patients taking any medications (e.g., proton pump inhibitors, H2 receptor blocking agents, antacids, or prokinetic agents) which might interfere with the action of the FDC oral suspension prior to the start of the study.
- •6.Female patients who are pregnant or are nursing mothers.
- •7.Patients who are determined to be at risk of COVID-19 as per investigator discretion.
结局指标
主要结局
Number and percentage of patients with adverse drug reactions (ADRs) and/or Other Pharmacovigilance- Relevant Information (OPRIs)
时间窗: Number and percentage of patients who discontinue study treatment due to ADRs and/or OPRIs | Global tolerability assessment by patients and investigators after 7 days of treatment on a 3-point scale ranging from “good†to “poor†tolerability
次要结局
- Percentage of patients achieving adequate heartburn or indigestion relief after 7 days of treatment.(Adequate heartburn or regurgitation relief was defined as no more than 1 day of mild heartburn or regurgitation episodes during the past 7 days post baseline visit.)
研究者
Dr Jayashri Krishnan
JSS Medical Research Asia Pacific Private Limited