NCT00986882已完成2 期
A Double-blind, Randomized, Single Dose, Placebo Controlled, Three Part Study to Evaluate the Safety and Tolerability, Efficacy and Dose Response of SAF312 in Postoperative Dental Pain Patients
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
- Novartis
- 入组人数
- 183
- 试验地点
- 1
- 主要终点
- To evaluate the safety, tolerability, efficacy and dose response of single oral doses of SAF312 in patients with postoperative dental pain
研究概览
简要总结
The study will assess the analgesic efficacy and safety and tolerability of a single oral dose of SAF312 in postoperative dental pain patients after 3rd 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Extraction of two or more impacted (partial or full) third molars. At least one of the impaction should be lower jaw.
- •Each patient will evaluate her/his post-surgical pain intensity prior to taking trial medication.
- •To be eligible for this trial, post surgical pain must be moderate to severe -- Subjects should be in good health otherwise as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening.
- •Female subjects should be either postmenopausal or should have had surgical sterilization.
排除标准
- •Patients with known hypersensitivity to diclofenac, aspirin, acetaminophen or to antipyretics or with allergies manifested by attacks of asthma, urticaria or acute rhinitis following treatment with aspirin or other agents with cyclooxygenase-inhibiting activity such as NSAIDs.
- •Use of antipyretic/analgesic drugs from 48 hrs pre-dose to 24 hrs postdose
- •Presence of bleeding disorder (history of excessive bleeding after dental procedures or minor injuries)
- •Patients with Diabetes mellitus.
- •Presence, history of, or family history of malignant hyperthermia or anesthesia-related events that may be suggestive of malignant hyperthermia.
- •An abnormal ECG at screening, including PR>200 ms, QRS>110 ms, QTcF<380 or >450 ms, lead II T wave abnormalities. Non-specific T wave abnormalities in leads other than lead II are permissible if not accompanied by any other morphological abnormalities.
- •Patients with infection e.g. dental abscess
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
SAF312A (2 doses in part B; 5 - 6 doses in part C)
Experimental
干预措施: SAF312A (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Ibuprofen
Active Comparator
干预措施: Ibuprofen (Drug)
结局指标
主要结局
To evaluate the safety, tolerability, efficacy and dose response of single oral doses of SAF312 in patients with postoperative dental pain
时间窗: 24 hours
次要结局
- To assess the pharmacokinetics of the single oral doses of SAF312 and Ibuprofen in patients with postoperative dental pain(24 hours)
- To measure: time-specific pain relief (PR), Total pain relief (TOTPAR), time to onset of analgesia, time to rescue medication(24 hours)
研究者
研究点 (1)
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