CTRI/2022/12/048631尚未招募未知
A Prospective, Randomized, Open-label, Parallel-group, Investigator-initiated Study to Evaluate and Compare the Safety and Effectiveness of Digifine Capsule coadministered with FDC of Pantoprazole plus Domperidone or Pantoprazole versus FDC of Pantoprazole plus Domperidone and Pantoprazole in Management of Patients with Functional dyspepsia.
Dr Ranjana G Deshmukh0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adult male or female patients between 18 to 60 years (both ages inclusive)
- •2. Patients with functional dyspepsia as per ROME IV criteria and currently not receiving any treatment since at least two weeks prior to screening (ROME IV criteria can be referred)
- •3. Patients had an upper endoscopy performed within 3 months before screening that showed no evidence of structural disease that was likely to explain the dyspepsia symptoms.
- •4. Patients willing to give their written informed consent to participate in the study and able to record answers on study-related questionnaires
- •5. Patients willing to comply with all aspects of the protocol
排除标准
- •1. Patients hypersensitive to active or inactive ingredients of investigational products
- •2. Patient with history of taking medicines responsible for QT prolongation
- •3. Patients with history of cardiac disorder (clinically significant bradycardia, sinus node dysfunction, prolonged QTc, cardiac conduction intervals, history of arrhythmia or at risk of serious ventricular arrhythmias)
- •4. Patients with history of clinically significant hepatic dysfunction, renal insufficiency, electrolyte disorders, which in the opinion of the investigator might affect patientâ??s safety while participating in the study or affect study treatment result analysis
- •5. Patients with history of gastrointestinal hemorrhage or obstruction or having any symptoms suggestive of gastrointestinal hemorrhage or obstruction or prolactinoma
- •6. Patients who have history significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure, hepatic diseases or renal disease as per investigatorâ??s judgment may impact the efficacy analyses for the study or put the Patientâ??s safety at risk based on prescribing information of pantoprazole and/or domperidone
- •7. Female patients who are pregnant, lactating, or planning to become pregnant
- •8. Patients (male and female both) not willing to use acceptable method of contraception
- •9. Patients scheduled to undergo surgery during the study period
- •10. Patients who have received any intervention in a clinical trial within 01 month prior to screening
- •11. Patients with history of alcohol or substance abuse which as per Investigators which may interfere with safety of patients or treatment evaluation while participating in the study
- •12. Current significant alcohol consumption or smoking tobacco based on investigators evaluation of patients lifestyle which may interfere with safety of patients or treatment evaluation while participating in the study
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