NCT00993863已完成2 期
A Randomized, Single-Dose, Double-Blind, Active- and Placebo-Controlled Study of ADL5859 for the Treatment of Pain After Surgical Removal of Impacted Third Molars
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Total pain relief 0-4 hours after study medication
研究概览
简要总结
The objective of this study is to evaluate the analgesic efficacy and safety of ADL5859 compared with placebo and an active control (ibuprofen) in subjects with acute dental pain after third molar extraction.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have 2 or more 3rd molars requiring extraction, including at least 1 partially or completely bone-impacted mandibular molar
- •experience moderate to severe pain intensity as measured by the Numeric Pain Rating Scale (NPRS) (score ≥ 5) within 6 hours after surgery
- •for male subjects, be surgically sterile or agree to use an appropriate method of contraception or have a sexual partner who is surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive
- •for female subjects, be using contraceptives, be postmenopausal, or have undergone hysterectomy or tubal ligation
- •be able to take oral study medications
排除标准
- •have positive results either on the urine screening tests for opiates, tetrahydrocannabinol,cocaine, amphetamines, barbiturates, benzodiazepines, phencyclidine, or propoxyphene or on the alcohol breathalyzer test
- •have a history of alcoholism or drug addiction or abuse within 5 years before dosing with study medication
- •have a history of chronic use (defined as daily use for > 2 weeks) of glucocorticoids,nonsteroidal anti-inflammatory drugs, or opiates for any condition within 6 months of study medication administration
- •have a known allergy or history of significant reaction to any of the known treatment medications (ADL5859-like compounds or ibuprofen) or rescue pain medication (acetaminophen)
- •have significant renal or hepatic disease, as indicated by clinical laboratory assessment
- •have a known history of epilepsy or seizure disorder, including history of febrile seizure, or any other medical or psychiatric condition that, in the judgment of the investigator, would put the subject at risk while in the study, could influence the results of the study, or could negatively affect the subject's ability to participate in the study
- •have a history or evidence of orthostatic hypotension at screening have a history of significant head trauma (head injury with loss of consciousness)
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
ADL5859 30 mg
Experimental
干预措施: ADL5859 30 mg (Drug)
ADL5859 100 mg
Experimental
干预措施: ADL5859 100 mg (Drug)
ADL5859 200 mg
Experimental
干预措施: ADL5859 200 mg (Drug)
ibuprofen 400 mg
Active Comparator
干预措施: ibuprofen 400 mg (Drug)
结局指标
主要结局
Total pain relief 0-4 hours after study medication
时间窗: 4 hours after study medication
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Safety and Efficacy Study of ADL5859 in Participants With Neuropathic Pain Associated With Diabetic Peripheral NeuropathyNeuropathic PainPeripheral NeuropathyNCT00603265Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)226
已完成
2 期
Study Evaluating the Analgesic Efficacy and Safety of ADL5859 in Participants With Rheumatoid ArthritisRheumatoid ArthritisNCT00626275Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)46
终止
2 期
Study to Assess the Efficacy, Safety, and Tolerability of ADL5747 in Participants With Postherpetic NeuralgiaPostherpetic NeuralgiaNCT01058642Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)41
已完成
2 期
Efficacy and Safety Study Evaluating ADL5859 and ADL5747 in Participants With Pain Due to Osteoarthritis of the KneeOsteoarthritis of the KneeNCT00979953Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)408
已完成
2 期
Study to Evaluate the Efficacy, Safety and Tolerability of N1539HysterectomyNCT01084161Alkermes, Inc.486