NCT02604576已完成3 期
Efficacy of Fixed-dose Combination of Bromopride and Simethicone Versus Isolated Bromopride in Participants With Functional Dyspepsia.
EMS10 个研究点 分布在 1 个国家目标入组 339 人开始时间: 2017年1月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 339
- 试验地点
- 10
- 主要终点
- Symptoms assessed by proportion of participants who have reduction equal to or greater than 50% in symptoms through questionnaire PADYQ
研究概览
简要总结
Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of fixed-dose combination of bromopride and simethicone versus isolated bromopride on research participants diagnosed with functional dyspepsia.
详细描述
Multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of fixed-dose combination of bromopride and simethicone versus isolated bromopride in the relief os dyspepsia symptoms on research participants diagnosed with functional dyspepsia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent;
- •Participants aged 18- 70 years;
- •Clinical diagnosis of functional dyspepsia according to Rome III criteria;
- •Minimum score of 22 points in PADYQ questionnaire
排除标准
- •Diagnosis of gastroesophageal reflux disease, irritable bowel syndrome, inflammatory bowel disease, gallstones, strongyloidiasis, giardiasis or ascariasis, clinical disease or significant psychological;
- •Positive diagnosis for Helicobacter pylori;
- •Clinically significant organic diseases in the HDE (High Digestive Endoscopy) prior to randomization;
- •History of esophageal surgery, gastrointestinal or other intra-abdominal surgery;
- •Hypersensitivity to the components of the formulations;
- •Allergy tartrazine yellow dye;
- •Allergy to aspirin;
- •Use of PPIs, H2 blockers, prokinetics, antibiotics, prostaglandins or bismuth salts in the last week before the screening visit;
- •Use of NSAIDs or aspirin more than two days a week (except AAS <325mg / day), other drugs that induce gastrointestinal symptoms;
- •Pregnant women or women without adequate contraception;
- •Advance Participation in clinical trial protocols in the last twelve (12) months (CNS Resolution 251 of August 7, 1997, Part III, subsection J), unless the investigator considers that there may be direct benefit to it;
- •Changes in hematological and biochemical tests: hemoglobin less than 12 g / dl, results with value 2 times the reference for AST, ALT, Gamma GT and alkaline phosphatase;
- •Diagnosis of neurological or psychiatric diseases or decompensated diabetes;
- •Use of drugs with anticholinergic action, narcotic analgesics, sedatives, hypnotics or tranquilizers;
- •Alcoholism or sporadic use of alcohol and illicit drug use.
研究组 & 干预措施
Group 1
Experimental
FDC Bromopride 10 mg and Simethicone 80 mg
干预措施: FDC Bromopride 10 mg and Simethicone 80 mg (Drug)
Group 2
Active Comparator
Bromopride 10 mg (Digesan ® - Sanofi Aventis)
干预措施: Bromopride 10 mg (Drug)
结局指标
主要结局
Symptoms assessed by proportion of participants who have reduction equal to or greater than 50% in symptoms through questionnaire PADYQ
时间窗: 4 weeks
次要结局
- Adverse events(4 weeks)
研究者
研究点 (10)
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