A Phase IIa, Double-blind, Randomized, 2-way Cross-over Study to Evaluate the Effect of a Single Dose of AZD1386 95 mg Compared to Placebo in a Multimodal Experimental Pain Model on Esophageal Sensitivity in GERD Patients With a Partial Response to PPI Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
研究概览
简要总结
The purpose of the study is to compare sensitivity of visceral pain in the esophagus using different pain stimuli.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Provision of signed informed consent form
- •BMI 18.5-35.0, inclusive
- •Continuous PPI treatment for GERD during the last 4 weeks
排除标准
- •Patients that have not experienced any GERD symptoms improvement at all after PPI treatment
- •Unstable or clinically significant disorders including cardiovascular, respiratory, renal, hepatic, metabolic, psychiatric, other gastrointestinal and esophageal disorders besides GERD
- •Prior surgery of the upper GI tract
研究组 & 干预措施
First AZD1386, then washout, then placebo
干预措施: AZD1386 (Drug)
First AZD1386, then washout, then placebo
干预措施: Placebo to AZD1386 (Drug)
First placebo, then washout, then AZD1386
干预措施: AZD1386 (Drug)
First placebo, then washout, then AZD1386
干预措施: Placebo to AZD1386 (Drug)
结局指标
主要结局
Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 1.5 Hours Post-Dose.
时间窗: 1.5 hours post dose
A probe (bag) was inserted 7cm above the lower esophageal sphincter (LES). Heat stimuli were applied by recirculation of heated water in the bag. Prior to recirculation the bag is filled with 7mL to ensure adequate mucosal contact. Water was heated up to a maximum of 63° C and the stimulation was continued until VAS 7 was reached. The intensities of the non-painful sensations were scored with the following descriptors added to facilitate the scoring: 1. = vague perception of mild sensation 2. = definite perception of mild sensation 3. = vague perception of moderate sensation 4. = definite perception of moderate sensation For painful sensations the patients will use the scale from 5-10 anchored at: 5. = pain detection 6. = slight pain 7. = moderate pain 8. = medium pain intensity 9. = intense pain 10. = unbearable pain
次要结局
- DBP(1.5 hours post dose)
- Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 0.5 Hours Post Dose(0.5 hours post dose)
- Time to Visual Analogue Scale 7 (VAS7) During Thermal Stimulation at 2.5 Hours Post Dose(2.5 hours post dose)
- Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 0.5 Hours Post Dose(0.5 hours post dose)
- Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 1.5 Hours Post-Dose(1.5 hours post dose)
- Volume at Visual Analogue Scale 7 (VAS7) During Mechanical Stimulation at 2.5 Hours Post-Dose.(2.5 hours post dose)
- Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation 0.5 Hours Post Dose(0.5 hours post dose)
- Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 1.5 Hours Post Dose(1.5 hours post dose)
- Current at Visual Analogue Scale 7 (VAS7) During Electrical Stimulation at 2.5 Hours Post Dose(2.5 hours post dose)
- AUCt(0 to 4 hours post dose)
- Cmax(0 to 4 hours post dose)
- Tmax(0 to 4 hours post dose)
- SBP(1.5 hours post dose)
- Pulse(1.5 hours post dose)
- QTcF(1.5 hours post dose)
- Body Temperature(1.5 hours post dose)
- Clinically Relevant Change of Laboratory Variables(Pre-entry to follow-up)