NCT00820079已完成2 期
A Phase 2B, Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Study to Investigate the Efficacy, Mechanism of Action, Pharmacokinetics, Safety and Tolerability of the mGluR5 Negative Allosteric Modulator ADX10059 as Monotherapy in Patients With Gastroesophageal Reflux Disease (GERD)
Addex Pharma S.A.11 个研究点 分布在 4 个国家目标入组 120 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
- 120
- 试验地点
- 11
- 主要终点
- Number of GERD symptom free days in week 2 of study medication treatment
研究概览
简要总结
Evaluation of the effect of ADX10059 on symptom control in patients with gastroesophageal reflux.
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
- •well controlled on a standard clinical symptoms controlled dose of PPI treatment
- •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
- •hiatus hernia > 3 cm
- •current diagnosis of co-existing psychiatric disease
- •known clinically significant allergy or known hypersensitivity to drugs
- •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 120 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 2 of study medication treatment
时间窗: 2 weeks
次要结局
- GERD symptoms(2 weeks)
- Sleep disturbance(2 weeks)
- Use of antacid rescue medication(2 weeks)
- Global assessment of GERD(2 weeks)
- Effect on lower oesophageal sphincter and reflux episodes(2 weeks)
研究者
研究点 (11)
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