NCT00448110已完成3 期
Randomized, Double-Blind, Active- and Placebo-Controlled Study of the Efficacy and Safety of Repeated Dosing of DIC075V Relative To Parenteral Ketorolac and Placebo in Patients With Acute Post-Op Pain After Abdominal or Pelvic Surgery
Javelin Pharmaceuticals13 个研究点 分布在 1 个国家目标入组 331 人开始时间: 2006年5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
- 331
- 试验地点
- 13
- 主要终点
- Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.
研究概览
简要总结
This study will compare repeated intermittent IV dosing of diclofenac in patients with moderate to severe post-surgical pain from abdominal or pelvic surgery.
详细描述
The primary objective is to evaluate the efficacy and safety of two dosage levels of parenteral diclofenac in providing pain relief as compared to placebo or Ketorolac tromethamine.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled within two weeks of the screening visit to undergo abdominal or pelvic surgery
- •Moderate to severe pain within 6 hours following completion of the required surgery.
排除标准
- •Surgical procedure involves a subcostal incision.
- •Chronic disease or recent cardiovascular events.
- •Known allergy or hypersensitivity to the active compounds or any of the excipients used in the study.
- •Additional Inclusion/Exclusion Criteria May Apply
研究组 & 干预措施
A
Experimental
intravenous diclofenac dosage level 1
干预措施: Intravenous Diclofenac (DIC075V) (Drug)
B
Experimental
intravenous diclofenac dosage level 2
干预措施: Intravenous Diclofenac (DIC075V) (Drug)
C
Active Comparator
intravenous ketorolac
干预措施: Intravenous Ketorolac (Drug)
D
Placebo Comparator
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Sum of the pain intensity differences (SPID) over the 0-48 hour time interval.
时间窗: 0-48 hours
次要结局
- SPID over the 0-24 hour interval(0-24 hours)
- Other measures of pain relief(Multiple)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic SurgeryPostoperative PainNCT00507026Pfizer277
已完成
3 期
Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)Osteoarthritis, KneeNCT01967550Novartis304
已完成
4 期
Topical Diclofenac Gel in Patients With Superficial Inflammation of the VeinsSuperficial Thrombophlebitis of the Upper LimbNCT00377806Novartis200
已完成
3 期
Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or ContusionAcute PainNCT00869063Cerimon Pharmaceuticals214
已完成
3 期
A Clinical Trial to Study the Effects of a Fixed Dose Combination of Diclofenac and Eperisone Hydrochloride With Plain Eperisone Hydrochloride in Patients With Low Back PainAcute Musculoskeletal Spasm Due to Low Back PainNCT01300312Eisai Co., Ltd.239