NCT00565760已完成3 期
A Double-Blind, Multi-Center Extension Study to Evaluate the Safety and Efficacy of Q8003 in Patients With Acute Moderate to Severe Pain
QRxPharma Inc.6 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2007年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Safety: adverse events
研究概览
简要总结
This is a Phase 3 double-blind, multiple dose safety extension study of Q8003 administered at daily doses up to 36 mg morphine/24 mg oxycodone (Q8003 36mg/24mg) over a treatment period of up to 4 weeks. Patients with acute moderate to severe pain who have completed participation in one of the designated QRxPharma, Inc. acute pain lead-in studies will be eligible for this trial.
详细描述
The currently designated acute pain lead-in study is Study Q8003-007, which is a safety and efficacy study of Q8003 in the management of post-bunionectomy 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
- Double (Participant, Investigator)
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
- •Patient has completed participation in one of the designated eligible QRxPharma, Inc. acute pain lead-in studies.
- •Patient has a BMI ≤
- •Patient will anticipate taking the first dose of study medication in this Extension Study no longer than 24 hours after taking the final dose of study medication in the lead-in study.
- •Patient is in good health as determined by the Investigator via physical examination at the Extension Study Baseline Visit.
- •If female, patient is at least one year post-menopausal (defined as one year without menses), surgically sterile (must be documented), or practicing effective contraception, in the opinion of the Investigator, and be willing to continue to use effective contraception for the duration of participation in the study.
- •If female, patient is non-lactating, and if of child-bearing potential, has a negative urine pregnancy test result at Baseline Visit.
- •Patient has a pulse-oximetry measurement ≥95%, a respiration rate ≥12 breaths/minute, systolic blood pressure ≥100 mm Hg, and diastolic blood pressure ≥50 mm Hg at the Extension Study Baseline Visit.
- •Patient is willing to refrain from driving throughout the duration of participation in the study.
排除标准
- •Patient has acute asthma, head injury, elevated intracranial pressure, convulsive states, congestive heart failure (NYHA classification of III or IV), current cardiac arrhythmia, current transient cerebral ischemic attacks, current uncontrolled unstable co-existent systemic disease, serious intercurrent illness, other medical condition, laboratory abnormality, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the study.
- •Patient has allergy, hypersensitivity, or contraindications to opioids.
- •Patient has poorly controlled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >95 mm Hg despite antihypertensive medication) at the Extension Study Baseline Visit.
- •Patient is currently taking tramadol or anticipates taking tramadol during the course of the study.
- •Patient is currently taking antipsychotic drugs, monoamine oxidase inhibitors, muscle relaxants, or medications for the treatment of depression.
- •Patient is currently taking any opioid analgesic other than Q8003 or other opioid study medication, or anticipates taking any opioid analgesic other than Q8003 or other opioid study medication during the course of the study.
- •Patient is at high risk of addiction: patient has a history of substance abuse (excluding nicotine or caffeine), a family history of substance abuse, or a history of adverse consequences related to substance abuse including legal issues.
- •Patient has a history of drug or alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements.
- •Patient has any medical, psychological, cognitive, social and/or legal conditions that could, in the opinion of the Investigator, compromise patient safety or interfere with the ability of the patient to give informed consent and/or comply with all study requirements, including the necessary time commitment.
- •Patient has received any investigational medication within 30 days prior to the first dose of study drug in this study other than Q8003 or is scheduled to receive any investigational drug other than Q8003 during the course of this study.
- •Patient has previously been admitted to the study.
研究组 & 干预措施
1
Experimental
干预措施: Q8003 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety: adverse events
时间窗: Up to 4 weeks with 3 weeks follow-up
次要结局
- Efficacy: difference in pain intensity scores from baseline(Up to 4 weeks with 3 weeks follow-up)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
2 期
Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy PatientsPostoperative PainNCT00831051QRxPharma Inc.197
已完成
3 期
Comparison of the Safety of Q8003 Versus Morphine Equivalent Doses of Its Components (Oxycodone and Morphine) in Bunionectomy PatientsPostoperative PainNCT01280331QRxPharma Inc.375
进行中（未招募）
3 期
A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPDChronic Obstructive Pulmonary DiseaseNCT06208306Sanofi700
已完成
3 期
Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy PatientsModerate to Severe Postoperative PainNCT01016808QRxPharma Inc.522
已完成
3 期
Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn's DiseaseCrohn's DiseaseNCT01541579Tigenix S.A.U.278