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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1. Percentage change in global overall symptom scale on Visit 2/Day 15 (±4days) days of treatment from baseline as assessed by severity of dyspepsia symptoms (Group A vs. Group C and D; Group B vs. Group C and D; and Group A versus Group B)
研究概览
简要总结
Dyspepsia is a common disease that accounts for ~5% of patients who visit their primary health care provider and functional dyspepsia (FD) accounts for 60-80% of all patients with dyspepsia (Jung HK et al., 2016). The FGID with upper abdominal pain and discomfort is the hallmark feature of functional dyspepsia. One of the unique features of functional dyspepsia is transient deficiency of digestive enzymes in the system. The global prevalence of FD varies from 11-30%, and Indian prevalence is reported to be 30.4% (Soni NK et al., 2020).
Digestive enzyme supplementation are from the natural source and required by the body to metabolize and digest complex food to prevent indigestion and for better GI heath. Some conditions (such as diarrhoea, constipation, dyspepsia, etc.) can change the normal balance of bacteria (flora) found in the stomach and intestines. For better improvement of digestion and restoring normal gut flora; probiotics are beneficial. Digestive enzymes and probiotics are essential for normal digestive function. The addition of probiotics to enzymes helps promote a healthy intestinal tract environment. Combination of digestive enzymes and probiotics exhibits beneficial action in metabolism and utilization of nutrients. Probiotics with digestive enzymes have been used to prevent bowel symptoms (such as gas, bloating, abdominal discomfort, etc.) and to treat lactose intolerance. Thus, the combination of digestive enzyme and probiotics would help in digestion and restore the normal flora which in turn would also aid digestion. Together, the combination would be useful in relieving GI discomfort as seen in dyspepsia, constipation, diarrhoea, lactose intolerance, etc. and thereby may even prevent IBS. (Soni NK et al., 2020).
Thus, the combination of digestive enzyme and probiotics like Digifine capsule along with PPIs or prokinetics may facilitate in better relief to patients with functional dyspepsia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male or female patients between 18 to 60 years (both ages inclusive)
- •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)
- •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.
- •Patients willing to give their written informed consent to participate in the study and able to record answers on study-related questionnaires
- •Patients willing to comply with all aspects of the protocol.
排除标准
- •Patients hypersensitive to active or inactive ingredients of investigational products
- •Patient with history of taking medicines responsible for QT prolongation
- •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)
- •Patients with history of clinically significant hepatic dysfunction, renal insufficiency, electrolyte disorders, which in the opinion of the investigator might affect patient‟s safety while participating in the study or affect study treatment result analysis
- •Patients with history of gastrointestinal hemorrhage or obstruction or having any symptoms suggestive of gastrointestinal hemorrhage or obstruction or prolactinoma
- •Patients who have history significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure, hepatic diseases or renal disease as per investigator‟s judgment may impact the efficacy analyses for the study or put the Patient‟s safety at risk based on prescribing information of pantoprazole and/or domperidone
- •Female patients who are pregnant, lactating, or planning to become pregnant
- •Patients (male and female both) not willing to use acceptable method of contraception
- •Patients scheduled to undergo surgery during the study period
- •Patients who have received any intervention in a clinical trial within 01 month prior to screening
- •Patients with history of alcohol or substance abuse which as per Investigator"s which may interfere with safety of patients or treatment evaluation while participating in the study
- •Current significant alcohol consumption or smoking tobacco based on investigator"s evaluation of patient"s lifestyle which may interfere with safety of patients or treatment evaluation while participating in the study.
结局指标
主要结局
1. Percentage change in global overall symptom scale on Visit 2/Day 15 (±4days) days of treatment from baseline as assessed by severity of dyspepsia symptoms (Group A vs. Group C and D; Group B vs. Group C and D; and Group A versus Group B)
时间窗: 1. Visit 2/Day 15 (±4days) days of treatment from baseline | 2. Visit 3/Day 31 (±4days) of treatment from baseline and from Day 14
2. Percentage change in global overall symptom scale on Visit 3/Day 31 (±4days) of treatment from baseline and from Day 14 as assessed by severity of dyspepsia symptoms (Group A vs. Group C and D; Group B vs. Group C and D; and Group A versus Group B)
时间窗: 1. Visit 2/Day 15 (±4days) days of treatment from baseline | 2. Visit 3/Day 31 (±4days) of treatment from baseline and from Day 14
次要结局
- Proportion of patients with adequate relief on Visit 2 and Visit 3 from baseline as assessed by total symptom score recorded under functional dyspepsia diary questions(Adequate relief defined as more than 50 percent reduction in the total symptom score based on functional dyspepsia symptom diary)
- Proportion of patients with adequate relief on Day 7 and Day 21 period from baseline(Day 7 and Day 21 period from baseline)
- Proportion of patients with decrease in severity of each symptom score assessed from functional dyspepsia symptom diary on Day 3 and Day 6 and Day 9 and Day 12 and Day 18 and Day 21 and Day 24 from baseline(Day 3 and Day 6 and Day 9 and Day 12 and Day 18 and Day 21 and Day 24)