NCT00943098已完成3 期
Efficacy and Safety of a Single s.c. Diclofenac HPBCD 75mg/1ml Injection as Compared to a Single i.m. Voltarol® 75mg/3ml, in the Treatment of Acute Moderate-to-severe Post-surgical Pain Following Dental Surgery (Impacted 3rd Molar Removal).
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
- 142
- 试验地点
- 3
- 主要终点
- Pain Intensity Difference (PID)
研究概览
简要总结
The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD 75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment of acute moderate-to-severe pain after dental impaction surgery.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal.
- •Patients experiencing moderate to severe post-operative pain within 6 hours from end of surgery.
- •Pre-operative laboratory tests in the reference ranges or without clinically significant abnormalities as judged by the Investigator.
排除标准
- •Surgery performed under general anaesthesia, or sedation.
- •Complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator.
- •Acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation.
- •Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other GI disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of NSAIDs.
- •Clinical signs or history of coagulation disorders that could be negatively affected by NSAIDs administration.
- •Hepatic or renal impairment.
- •Patients with significant cardiac impairment, history of cerebrovascular disease, history or peripheral arterial disease, uncontrolled hypertension.
- •Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication components.
- •Patients under chronic treatment with topical or systemic analgesics/NSAIDs.
- •Patients under treatment with any medication that may affect the treatment efficacy evaluation.
- •Patients under treatment with any medication whose concomitant use may be susceptible to interactions with diclofenac or may affect safety.
研究组 & 干预措施
Voltarol 75mg/3ml i.m.
Active Comparator
干预措施: Voltarol 75mg/3ml i.m. (Drug)
Diclofenac HPBCD s.c. 75mg/ml
Experimental
干预措施: Diclofenac HPBCD s.c. 75mg/ml (Drug)
结局指标
主要结局
Pain Intensity Difference (PID)
时间窗: 1.5 hours
Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
次要结局
- PIDs(at 8 hours post-dose.)
研究者
研究点 (3)
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