CTRI/2016/03/006763尚未招募3 期
A Phase III, Multi-Center, Open Label, Comparative, Active-Control, Parallel group, Randomized, Study to Evaluate the Efficacy and Safety of Acotiamide in Indian Adult Patients with Functional Dyspepsia-Post Prandial Distress Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 5
- 主要终点
- Responder rates for Overall treatment effect (OTE) by using 7-point Likert scale
研究概览
简要总结
This is a phase III, openlabel, active control, parallel group, randomized, prospective, multicenter, efficacy,and safety study. Adult male and female (18-64 years) patients with functionaldyspepsia-post prandial distress syndrome as defined by the Rome IIIclassification, who will meet all the inclusion criteria and none of theexclusion criteria will be enrolled in the study. The randomization would be in1:1 ratio among the study treatments. The primary objective of the study is toevaluate the efficacy of Acotiamide in patients with functional dyspepsia-postprandial distress syndrome. The secondary objective is to evaluate thetolerability and safety of Acotiamide.
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 64.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ The patient is willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures • Patients with Functional Dyspepsia-Post Prandial distress syndrome (FD-PDS) as defined by the Rome III classification “(Postprandial fullness or early satiation for at least 6 months or two or more of the following symptoms at a moderate or severe level within the previous 3 months: upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, nausea, vomiting or excessive belching.)†• Patients experienced two or more of the following symptoms at a moderate or severe level for 2 days or longer during the baseline period: postprandial fullness, upper abdominal bloating, or early satiety.
- •â€¢ If patients have coexisting epigastric pain syndrome symptoms (epigastric pain, epigastric burning), but the symptom causing the most distress at the time of obtaining informed consent had to be one of the following meal-related symptoms: postprandial fullness, upper abdominal bloating or early satiation.
- •â€¢ Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study • Clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the results are deemed not clinically significant for inclusion into this study by the investigator.
排除标准
- •â€¢ Patients with structural disease that is likely to explain the symptom (GERD, erosion, ulcer, hiatal hernia, bleeding, malignancy or Barretts esophagus) • Patients have heartburn in last 12 weeks before obtaining informed consent and during the baseline period • Patients with irritable bowel disease (IBS) • Patients with diabetes mellitus requiring treatment • Patients with serious anxiety disorder • Patients with depression and/or sleep disorder • Patients with biliary tract disease and/or pancreatitis (including chronic pancreatitis) • Patients with presence of any symptom indicating serious or malignant disease • Abnormality in the electrocardiogram at rest • Hypersensitive to any of the investigational product or its components • Currently have a clinically significant neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal and/or urological disorder • History of drug or alcohol abuse • Currently participating in another investigational study or has participated in an investigational study within 90 days prior to randomization • Patients with the current/past infections such as tuberculosis, herpes and/or patients with immune system disorders like HIV and SLE • Any other disease state which could interfere with trial participation or trial evaluation as per investigator’s discretion • Women of child-bearing potential, pregnant or lactating women, women practicing contraception by other than barrier methods or intending to donate eggs within the projected duration of the study and post-study follow-up period • The physician is of the opinion that patient’s trial medications would put the patient at risk.
结局指标
主要结局
Responder rates for Overall treatment effect (OTE) by using 7-point Likert scale
时间窗: Baseline to Week 4 or End of treatment
次要结局
- Elimination rate of post-prandial fullness, upper abdominal bloating and early satiety(Baseline to last reporting time point)
- Overall treatment effect (OTE) by using 7-point Likert scale(Baseline to Weekly)
- The improvement of individual symptom (upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiation, excessive belching, nausea, vomiting and heartburn) score on a severity scale of 0-3 (none, mild, moderate and severe)(Baseline to Weekly)
- Assessment of the effects of treatment on disease-specific QoL by using Short Form-Nepean Dyspepsia Index questionnaire (SF-NDI)(Baseline to Week 4 or End of treatment)
- Treatment emergent clinical & laboratory adverse events (TEAEs)(All time points)
研究者
研究点 (5)
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