NCT01685684已完成3 期
A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-Controlled, Safety, Tolerability, and Efficacy Study of Oxycodone DETERx™ Versus Placebo in Opioid-Experienced and Opioid-Naive Subjects With Moderate-to-Severe Chronic Low Back Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 740
- 主要终点
- Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase
研究概览
简要总结
The purpose of this study is to evaluate the analgesic efficacy of Oxycodone DETERx compared with placebo in opioid-experienced and opioid-naive subjects with moderate-to-severe chronic low back pain requiring around-the-clock opioid analgesia for an extended period of time.
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
- Double (Participant, Investigator)
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 female 18-75 years of age (inclusive) at the time of consent.
- •Must have a clinical diagnosis of moderate-to-severe CLBP for a minimum of 6 months prior to screening.
- •Must qualify for ATC opioid therapy for treatment of CLBP.
- •Must be classified as non-malignant and non-neuropathic (Class 1 and 2), neuropathic (Class 3), or symptomatic for more than 6 months after low back pain surgery (Class 9) based on the Quebec Task Force Scale score.
- •Female subjects of childbearing potential will use an acceptable method of birth control.
- •Must be in general good health based on screening physical examination.
- •Must be willing and able to comply with all study procedures and visit requirements.
排除标准
- •Known to be refractory or intolerant to the analgesic effects of opioids or have failed previous opioid therapy.
- •A medical condition that would compromise the subject's ability to swallow, absorb, metabolize, or excrete the study drug, including (but not limited to) intractable nausea and/or vomiting and/or severe gastrointestinal narrowing (pathologic or iatrogenic), bowel obstruction, ileostomy, colostomy, or is suspected of having paralytic ileus.
- •A surgical procedure for back pain within 6 months prior to the Screening Visit.
- •Any other chronic pain condition other than CLBP that would interfere with the assessment of CLBP (e.g., osteoarthritis, rheumatoid arthritis, post-herpetic neuralgia, pain associated with diabetic neuropathy, fibromyalgia, migraine headaches requiring opioid therapy).
- •Known history of major depressive disorder that is not controlled with medication or has other conditions that produce significant cognitive or emotional disability.
- •Any clinically significant unstable medical abnormality or acute or chronic disease of the cardiovascular, gastrointestinal, respiratory (e.g., chronic obstructive pulmonary disease), hepatic, or renal systems.
- •Known history of alcohol and/or drug abuse.
- •Positive urine drug screen for illegal or non-prescribed drugs
- •Known history of seizure disorder, epilepsy, convulsions, or increased intracranial pressure anytime during the subject's life except pediatric febrile seizures.
- •Known history of head injury within 6 months of Screening Visit.
- •Current malignancy or a history within past 2 years of malignancy, with the exception of basal cell carcinoma or cervical carcinoma in situ that have been successfully treated.
- •Positive for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or hepatitis C antibody
- •Subject is not able or is unwilling to meet the study attendance requirements.
- •Other protocol specific inclusion and exclusion criteria may apply.
研究组 & 干预措施
Oxycodone DETERx
Experimental
干预措施: Oxycodone DETERx (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Average Pain Intensity Measured by the Change in Pain Intensity-Numeric Rating Scale (PI-NRS) Scores From Randomization Baseline to Week 12 of the Double-blind Maintenance Phase
时间窗: Randomized Baseline through Week 12
The PI-NRS is an 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst possible pain).
次要结局
- Time-to-exit From the Study for All Causes(Randomization Baseline through Week 12)
- Percent Reduction in Pain Intensity for Responders(Screening Baseline through Week 12)
- Weekly Changes in Pain Intensity(Randomization Baseline and weekly through Week 12)
- Rescue Medication Usage by Dose(Randomization Baseline through Week 12)
- Rescue Medication Use by Dosage(Randomization Baseline through Week 12)
- Patient Global Impression of Change (PGIC)(Screening Baseline through Week 12)
- Changes in Quality of Life(Randomization Baseline through Week 12)
- Change in Level of Physical Disability Using the Roland Morris Disability Questionnaire (RMDQ)(Randomization Baseline and Week 12)
研究者
相似试验
已完成
2 期
Evaluation of DEX-IN During Outpatient ProceduresPainNCT03348423Baudax Bio45
终止
2 期
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following BunionectomyPain, Post-operativeNCT02169336Baudax Bio95
已完成
4 期
Morphine vs. Oxycodone for Postoperative Pain ManagementHysterectomyMyomaPostoperative PainOpioidsNCT00528177Ullevaal University Hospital90
已完成
3 期
Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization ProcedurePain PostoperativeLiver CancerNCT03059238Sun Yat-sen University213
已完成
4 期
Dose Response Study of Dexmedetomidine in Orthopaedic Spine Surgery PatientsPain, PostoperativeNCT02454881Turku University Hospital107