A prospective, randomized, assessor-blinded, two arm, comparative, real-world clinical study to evaluate the effectiveness and safety of a fixed-dose combination (FDC) of magaldrate, activated dimethicone, oxetacaine, and dicyclomine compared with FDC of magaldrate, simethicone, and oxetacaine for symptomatic relief in adult patients with acute gastrointestinal dyspeptic symptoms.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 2
研究概览
简要总结
This will be a prospective, randomized, assessor-blinded, two-arm, comparative, real-world, post-marketing clinical study to evaluate the effectiveness and safety of Formulation A (fixeddose combination oral suspension of magaldrate, activated dimethicone, oxetacaine, and dicyclomine) as compared to Formulation B (fixed-dose combination oral suspension of magaldrate, simethicone, and oxetacaine) for symptomatic relief in adult patients with acute gastrointestinal dyspeptic symptoms. Study assessments will be conducted through a telephonic follow-ups and on-site visits. Following randomization on Day 0, patients will remain at the study site for assessment of time to first meaningful symptom relief after administration of the first dose of study medication. Patients will subsequently be followed up via telephonic assessments at 24 hours (Day 1) and on Day 3, and will attend an on-site end-of-study visit on Day 5.
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
- •1.Patients of either gender between 18 to 60 years of age, both inclusive.
- •2.Patients presenting with acute gastrointestinal dyspeptic symptoms such as heartburn, regurgitation, epigastric pain or burning, bloating, belching and abdominal cramps for at least 48 hours prior to screening and enrollment.
- •3.Patients willing to provide written informed consent and comply with the protocol requirements.
排除标准
- •Patients with known or suspected peptic ulcer disease with alarm features such as unexplained weight loss, melena, hematemesis, gastrointestinal bleeding, or history of gastrointestinal surgery affecting motility.
- •Patients with known hypersensitivity to any component of Test or Reference product.
- •Pregnant or lactating females or female patients of childbearing potential unwilling to undergo pregnancy testing or use effective contraception, as applicable.
- •Use of other antacids, proton pump inhibitors, H2 blockers, or antispasmodics within 48 hours prior to randomization.
- •Participation in another clinical trial within 3 months prior to screening.
- •Patients with any severe concomitant illness that in the investigators opinion would interfere with study participation or outcome assessment.
- •Any other reason for which the investigator feels that the patient should not participate.
研究者
Dr Jayesh Sanmukhani
Clinexcel Research