NCT01357837已完成2 期
A Randomized 4 Week Phase IIa Trial Evaluating the Efficacy, Safety, and Tolerability of GRT6005, a New Centrally Acting Analgesic, in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 207
- 试验地点
- 26
- 主要终点
- Change from baseline in the pain intensity scores during the last week of the 4-week treatment period
研究概览
简要总结
The purpose of the trial is to determine whether GRT6005 is effective in patients with pain due to osteoarthritis of the knee.
详细描述
The purpose of this study is to evaluate the safety, tolerability and efficacy of 3 doses of GRT6005 taken once daily for 4 weeks in outpatients with moderate-to-severe painful osteoarthritis of the knee.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •painful Osteoarthritis of the knee based on American College of Rheumatology Criteria
- •signed informed consent
- •on stable analgesic medications for painful osteoarthritis with regular analgesic intake for at least 3 months
- •pain intensity score of 4 or greater on the 11-point numeric rating scale (where 0 indicates "no pain" and 10 indicates "pain as bad as you can imagine").
排除标准
- •Substance Abuse
- •Significant cardiac disease
- •Presence of risk factors for Torsades de Pointes and chronic severe cardiac disease
- •History of seizure disorder
- •Chronic gastrointestinal disease
- •Conditions that contribute and confound to the assessment of pain
- •Surgery or painful procedure during or within 3 months of enrollment
- •Subjects with impaired renal function
- •Subjects with impaired hepatic function
- •Female subjects who are breastfeeding
- •History of chronic hepatitis B or C or human immunodeficiency virus infection, or presence of acute hepatitis A, B, or C within the past 3 months.
- •Clinically relevant history of hypersensitivity or allergy to paracetamol, opioids or the excipients.
研究组 & 干预措施
Matching Placebo
Placebo Comparator
Once daily oral administration of matching placebo for 4 weeks.
干预措施: Matching Placebo (Drug)
75 µg GRT6005
Experimental
Once daily oral administration of GRT6005 for 4 weeks.
干预措施: GRT6005 (Drug)
200 µg GRT6005
Experimental
Once daily oral administration of GRT6005 for 4 weeks.
干预措施: GRT6005 (Drug)
400 µg GRT6005
Experimental
Once daily oral administration of GRT6005 for 4 weeks.
干预措施: GRT6005 (Drug)
结局指标
主要结局
Change from baseline in the pain intensity scores during the last week of the 4-week treatment period
时间窗: 4 weeks
次要结局
- Patient's Global Impression of Change (PGIC)(4 weeks)
- Weekly current pain intensity changes from baseline(4 weeks)
- Rescue medication use(4 weeks)
- Change from baseline in quality of health as measured by Short Form-12 Health Survey(4 weeks)
- Response measured in percentage change of pain intensity since baseline(4 weeks)
- Clinician's Global Impression of Change (CGIC)(4 weeks)
- Change from baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the 4 week treatment period(4 weeks)
- Plasma concentration(4 weeks)
- Time to withdrawal from study(4 weeks)
- Leeds Sleep Evaluation Questionnaire to quantify subjective impressions of sleep and waking(4 weeks)
- Quality of Life EuroQoL-5 Dimension score, change from baseline(4 weeks)
- Clinical Opioid Withdrawal Scale(4 weeks)
- Discontinuation from study due to treatment related adverse events(4 weeks)
研究者
研究点 (26)
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