NCT00810485已完成2 期
A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-ranging, Multi-centre Study to Investigate the Efficacy, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 in Patients With Gastroesophageal Reflux Disease (GERD) Who Are Partial Responders to Proton Pump Inhibitor (PPI) Treatment
Addex Pharma S.A.4 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 298
- 试验地点
- 4
- 主要终点
- Number of GERD symptom free days in week 4 of study medication treatment
研究概览
简要总结
The purpose of this study is to evaluate the effect of ADX10059 in patients with gastroesophageal reflux disease who are partial responders to proton pump inhibitors
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
- Double (Participant, 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
- •diagnosis of typical GERD
- •partial responder to a stable standard clinical symptoms control dose of PPI therapy
- •body mass index ≤ 32 kg/m2
排除标准
- •exclusively atypical symptoms of GERD
- •symptoms that have been shown not to be associated with GERD
- •erosive oesophagitis
- •treated with a dose of PPI greater than the dose indicated for clinical symptom control of GERD
- •hiatus hernia > 3 cm
- •current diagnosis of co-existing psychiatric disease
- •known clinical significant allergy or known hypersensitivity to drugs
- •is pregnant or breast-feeding
- •has received sodium valproate or topiramate within 30 days of Screening
- •has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study
研究组 & 干预措施
ADX10059 100 mg
Experimental
twice-daily
干预措施: ADX10059 (Drug)
ADX10059 50 mg
Experimental
twice-daily
干预措施: ADX10059 (Drug)
ADX10059 150 mg
Experimental
twice-daily
干预措施: ADX10059 (Drug)
ADX10059 Matching Placebo
Placebo Comparator
twice-daily
干预措施: ADX10059 Matching Placebo (Drug)
结局指标
主要结局
Number of GERD symptom free days in week 4 of study medication treatment
时间窗: 4 weeks
次要结局
- GERD symptoms(4 weeks)
- Sleep disturbance(4 weeks)
- Use of antacid medications(4 weeks)
- Global assessment of GERD(4 weeks)
- Safety and tolerability assessments(4 weeks)
研究者
研究点 (4)
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