A Study to Investigate the Genetic Variation of Dopamine Pathway Associated With the Observed Effects of a New Treatment in Former Studies in Patients With Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 8
- 主要终点
- Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase
研究概览
简要总结
Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling for genotyping purposes. In addition they will compete the personality questionnaires they had completed in the former trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have completed T1001-01 or T1001-02 study (Visit 5 completed)
- •are men or women of at least 18 years of age
- •have given written informed consent approved by the relevant Ethics Committee governing the study sites
排除标准
- •have any close relationship with the Investigators or the Sponsor
- •are under legal protection, according to the national law
研究组 & 干预措施
Unique study arm
干预措施: Blood sampling for genotyping (Genetic)
Unique study arm
干预措施: Personality Questionnaires completion (Other)
结局指标
主要结局
Number of participants with Single Nucleotide Polymorphisms (SNPs) variation of catechol-O-methyltransferase
时间窗: Time zero equals baseline
SNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of monoamine oxidase
时间窗: Time zero equals baseline
SNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of dopamine B hydroxylase
时间窗: Time zero equals baseline
SNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of dopamine receptor 3
时间窗: Time zero equals baseline
SNPs will be analyzed with Sanger based genotyping or equivalent method
Number of participants with SNPs variation of brain-derived neurotropic factor genes
时间窗: Time zero equals baseline
SNPs will be analyzed with Sanger based genotyping or equivalent method
次要结局
- Number of participants with SNPs variation of tryptophan hydroxylase-2(Time zero equals baseline)
- Number of participants with SNPs variation of 5-hydroxytryptamine transporter(Time zero equals baseline)
- Number of participants with SNPs variation of 5-hydroxytryptamine receptor 2A(Time zero equals baseline)
- Number of participants with SNPs variation of serotonin transporter gene-linked polymorphic region genes(Time zero equals baseline)
- Number of participants with SNPs variation of opioid receptor gene(Time zero equals baseline)
- Number of participants with SNPs variation of fatty acid amid hydrolase gene(Time zero equals baseline)
- Assessment of Cronbach alpha of the personality questionnaire used in this study and the former ones(Time zero equals baseline)