NCT00942448已完成3 期
Efficacy and Safety Study of Diclofenac HPBCD 25, 50 mg/ml Administered as Single s.c. Dose, in the Treatment of Acute Moderate-to-severe Post-surgical Pain From Dental Surgery (Impacted 3rd Molar Extraction)
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
- 306
- 试验地点
- 6
- 主要终点
- Pain Intensity Difference (PID) on a 0-100 VAS
研究概览
简要总结
The present study is proposed to evaluate the efficacy and safety of single doses of Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) 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
Diclofenac HPBCD s.c. 25mg/ml
Experimental
干预措施: Diclofenac HPBCD (Drug)
Diclofenac HPBCD s.c. 50mg/ml
Experimental
干预措施: Diclofenac HPBCD (Drug)
Diclofenac HPBCD s.c. 75mg/ml
Active Comparator
干预措施: Diclofenac HPBCD (Drug)
Placebo s.c. (1ml)
Placebo Comparator
干预措施: Placebo s.c. (Other)
结局指标
主要结局
Pain Intensity Difference (PID) on a 0-100 VAS
时间窗: at 1.5 hours after treatment administration
Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
次要结局
- PID(at 8 hours post-dose.)
研究者
研究点 (6)
Loading locations...
相似试验
已完成
3 期
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental SurgeryDental PainNCT00943098IBSA Institut Biochimique SA142
已完成
2 期
Effect of Preoperative Diclofenac Potassium on Postoperative Endodontic PainPulpitis - IrreversibleNCT03341260Cairo University70
已完成
3 期
Voltaren Emulgel 2% Acute Ankle Sprain Non Inferiority StudyPainNCT04052620GlaxoSmithKline313
终止
4 期
Efficacy of Diclofenac Potassium Versus Acetaminophen in Febrile Children With Acute Upper Respiratory Tract InfectionsFeverNCT01019980Novartis Pharmaceuticals2
Unknown
不适用
Efficacy of Preoperative Diclofenac Potassium- Acetaminophen Combination on Anesthetic Success in Patients With Symptomatic Irreversible Pulpitis: a Randomized Controlled TrialSymptomatic Irreversible PulpitisNCT04593160Cairo University72