A Prospective, Non-Interventional, Multicentric, Single arm, Open Label, Post Marketing Surveillance Clinical Study to Evaluate the Safety and Efficacy of FDC of Sodium Alginate 250 mg, Sodium Bicarbonate 106.5 mg and Calcium Carbonate 187.5 mg Chewable tablets for the Management of Symptoms of Gastroesophageal Reflux Disease
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 501
- 试验地点
- 4
- 主要终点
- Evaluate proportion of patients with adverse events reported during the study.
研究概览
简要总结
A Prospective Non interventional Multicentric Single arm Open Label PMS Clinical Study to Evaluate the Safety and Efficacy of FDC of Sodium Alginate 250 mg Sodium Bicarbonate 106.5 mg and Calcium Carbonate 187.5 mg Chewable Tablets for the management of symptoms of gastroesophageal reflux disease.
Patients will be instructed to administer Fixed Dose Combination of Sodium Alginate 250 mg Sodium Bicarbonate 106 .5 mg and Calcium Carbonate 187.5 mg Chewable tablets i.e. two tablets four times a day after each meal and at bedtime orally for 7 days of treatment duration
Following are the subject study visits:
Visit 1 Screening Visit Day -1 to Day 0
Visit 2 Baseline Visit Day 0
Visit 3 End of Study Visit Early Termination Visit Day 7
This is a single arm and open label study. Patients will be assigned into single group to receive test product. So, randomization procedure is not required.
This is an open label study. So, blinding procedure is not necessary.
Statistical Analysis Plan SAP shall be finalized prior to database lock. The SAP shall include detailed statistical aspects of the efficacy and safety analysis.
Statistical tests shall be conducted at the 5 Percent significance level unless otherwise indicated
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female patients more than 18 years of age.
- •Patients who have been prescribed FDC of Sodium Alginate Sodium Bicarbonate and Calcium Carbonate Chewable tablets for the treatment of reflux related symptoms in line with the marketing authorization during the last 24 hours prior to the study screening.
- •Patients who have experienced reflux related symptoms such as heartburn and or regurgitation during the 48-hour prior to the study screening.
- •Patients willing to sign informed consent form.
排除标准
- •Patients with highly restricted salt/sodium diet e.g., in some cases of cardiac failure, renal impairment, hypertension, and edema states.
- •Patients with known cases of hypercalcemia, nephrocalcinosis and recurrent calcium containing renal calculi.
- •Patients with known or suspected hypersensitivity to the active substance or any of the excipients.
- •Patient who has taken FDC of Sodium Alginate, Sodium Bicarbonate and Calcium Carbonate Chewable tablets during the last 12 weeks (except for the previous 24 hours),
- •Patients with any other conditions or diseases that an investigator considers it as inappropriate to enter the study as per the approved label.
- •Patients taking any medications which might interfere with the action of sodium alginate Chewable tablets prior to the start of the study.
- •Patient with history of received an investigational product or participation in another trial involving a marketed or investigational drug in the past 90 days prior to screening.
- •Patient who has already previously enrolled in this study.
- •Female patients who are pregnant or planning to become pregnant or nursing mothers.
- •Patient not willing to comply with all aspects of the protocol requirements.
结局指标
主要结局
Evaluate proportion of patients with adverse events reported during the study.
时间窗: Visit 2 (Day 0), Visit 3 (Day 7)
次要结局
- Secondary Safety Endpoints (assessment of Laboratory parameters, Vital signs)
- Change in Modified DeMeester clinical symptoms score of heartburn & regurgitation
- Change in Modified FSSG Score(Visit 2 (Day 0), Visit 3 (Day 7))
- Patients overall satisfaction at the end of study.(Visit 3 (Day 7))
研究者
Dr Aditi Datta
Biosite Research Private Limited