EN20-01: A 24 Week Study to Evaluate the Safety and Efficacy of CNTX-6970 in Subjects With Moderate to Severe Knee Osteoarthritis Pain.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 16
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)
研究概览
简要总结
The primary objective of this study is to evaluate the safety and efficacy of CNTX-6970 for the treatment of pain related to OA of the knee compared to placebo. CNTX-6970 is being developed as a new treatment for chronic pain, including painful osteoarthritis of the knee.
详细描述
The study will employ a randomized, allocation-concealed, multicenter, placebo-controlled, multi-period crossover design (Schmid et al, 2018). This multi-period crossover randomized, controlled trial allows comparability and assessment of efficacy through repeated exposures within each subject to the active treatment and a control (placebo) in randomized sequence. Such multi-period crossover designs are ideal for treatments with rapid onset of action and short half-life such as the asset under study here. We have strived to minimize the complexity of this powerful design by using only 2 blocks with 2 periods each. The modest additional complexity of the proposed multi-period crossover design, compared to a parallel-groups design, is justified by the marked improvement in efficiency. The gains in efficiency afforded by the multi-period crossover design allow a substantial reduction in sample size without sacrificing statistical power.
The trial will compare an active treatment vs. placebo. Each block will consist of two treatment periods with each period lasting 6 weeks. Treatment assignments (active drug versus placebo) will be randomized for each patient to the two periods within each block. The period length of 6 weeks was chosen based on several considerations: (i) Most efficacious analgesic drugs demonstrate separation from placebo by 6 weeks; (ii) The decision to move CNTX-6970 forward to Phase 3 will require a clinically meaningful separation from placebo by 6 weeks; (iii) In this Phase 2 study, implementing a treatment block longer than 6 weeks would make the overall design more challenging and burdensome by extending the duration of overall testing beyond 6 months; (iv).
In this study, the placebo will consist of inactive tablets identical to the active treatment tablets. Treatment assignments (active drug versus placebo) will be randomized for each patient to the two treatment periods within each block.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding of the randomization assignment from trial subjects, staff from the Clinical Sites, CCC, and DCC will be ensured through the use of the IXRS.
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
300mg BID CNTX-6970, Then Placebo
Participants initially received 300 mg BID of CNTX-6970 for 6 weeks (Block 1, Period 1). Following this, they were administered matching placebo BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received 300 mg BID of CNTX-6970 again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received a matching placebo for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.
干预措施: CNTX-6970 (Drug)
300mg BID CNTX-6970, Then Placebo
Participants initially received 300 mg BID of CNTX-6970 for 6 weeks (Block 1, Period 1). Following this, they were administered matching placebo BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received 300 mg BID of CNTX-6970 again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received a matching placebo for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.
干预措施: Placebo (Drug)
Placebo, then 300 mg BID CNTX-6970
Participants initially received placebo BID for 6 weeks (Block 1, Period 1). Following this, they were administered 300 mg CNTX-9670 BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received placebo BID again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received a 300 mg CNTX-6970 BID for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.
干预措施: CNTX-6970 (Drug)
Placebo, then 300 mg BID CNTX-6970
Participants initially received placebo BID for 6 weeks (Block 1, Period 1). Following this, they were administered 300 mg CNTX-9670 BID for another 6 weeks (Block 1, Period 2). After a total of 12 weeks, participants received placebo BID again for 6 weeks (Block 2, Period 1). Finally, after 18 weeks of total treatment, participants received a 300 mg CNTX-6970 BID for an additional 6 weeks (Block 2, Period 2), completing a 24-week study period.
干预措施: Placebo (Drug)
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-A)
时间窗: 24 Weeks
The primary outcome measure used to assess efficacy will be patient-reported knee pain using the WOMAC Part A (Bellamy, et al., 1988).We will use the numerical rating scale version of the WOMAC, with the subject assessing each of 5 questions using an 11-point (0 to 10) scale; the total score is the sum of the individual item scores (range 0-50). A higher WOMAC score represents worse symptom severity.
Treatment Emergent Adverse Events (TEAEs)
时间窗: 24 Weeks
The primary safety endpoint is the incidence of treatment emergent adverse events (TEAEs), reported between the administration of study drug on Day 1 and the completion of the study at week 24 or early termination.
次要结局
- Numeric Rating Scale (NRS)(24 Weeks)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC-C)(24 Weeks)
- Hospital Anxiety and Depression Scale (HADS) - Anxiety(24 Weeks)
- Patient Global Impression of Change (PGIC)(24 Weeks)
- Serum Levels of Cytokines and Chemokines(24 Weeks)
- MCP-1/CCR-2(24 Weeks)
- Hospital Anxiety and Depression Scale (HADS) - Depression(24 Weeks)
- PROMIS - 6A(24 Weeks)
- Staircase-evoked Pain Assessment(24 Weeks)
研究者
Maurizio Fava, MD
Psychiatrist in Chief
Massachusetts General Hospital