A Phase 3 Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NKTR-181 in Opioid-Naive Subjects With Moderate to Severe Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,189
- 试验地点
- 54
- 主要终点
- The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline)
研究概览
简要总结
The purpose of this study is to determine whether a new opioid molecule, NKTR-181, is effective for the relief of moderate to severe chronic low back pain as compared to a placebo.
详细描述
This is an enriched enrollment, randomized withdrawal study with an open label, dose-titration period followed by a randomized, double-blind, placebo-control treatment of twelve weeks. During the double-blind treatment period, this study will evaluate the analgesic effect of NKTR-181 versus placebo in patients with moderate to severe chronic low back pain.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or non-pregnant, non-nursing female aged 18 to 75 years old
- •Clinical diagnosis of moderate to severe, chronic non-neuropathic low back pain for at least six months
- •Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics
- •Opioid analgesia is necessary
- •Currently taking no more than 10 mg morphine sulfate equivalents per day of short acting opioids for 14 days prior to entry
- •Females of child bearing potential must be using a highly effective form of birth control. All subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug.
- •Willing and able to provide informed consent
排除标准
- •Taking extended release or long-acting opioids within 6 months
- •History of hypersensitivity, intolerance, or allergy to opioids
- •Compression of spinal nerve root; spinal fracture, tumor, or abscess
- •Surgical procedures on the low back in the last 12 months or facet nerve root block or radiofrequency ablation in the last 3 months
- •Untreated moderate to severe sleep apnea
研究组 & 干预措施
Placebo
Placebo to match NKTR-181 twice daily (BID) tablets
干预措施: Placebo to match NKTR-181 BID tablets (Drug)
NKTR-181
NKTR-181 twice daily (BID) tablets
干预措施: NKTR-181 BID tablets (Drug)
结局指标
主要结局
The Change in Weekly (ie, 7-day Average) Pain Score at the End of Double-blind, Randomized Treatment Period, Relative to the Weekly Score at the End of Titration (Double-blind Baseline)
时间窗: 12 Weeks of randomized double blinded period
The daily pain intensity is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
次要结局
- Responder Analysis Based on Percent Reduction in Pain Intensity(Screening Baseline through Week 12)
- Patient Global Impression of Change (PGIC): Number of Responders(Screening Baseline through Week 12)
- Change in Sleep Quality in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)(Screening Baseline through Week 12)
- Change in Sleep Quantity Measure in Hours in the Medical Outcome Study Sleep Scale - Revised (MOS Sleep-R)(Screening Baseline through Week 12)
- Change in Roland Morris Disability Questionnaire (RMDQ)(Screening Baseline through Week 12)