A Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Tolerability of 50 mg Diclofenac Potassium Soft Gelatin Capsules Compared With 400 mg Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose
研究概览
简要总结
The study is designed to assess the efficacy and tolerability of diclofenac potassium soft gelatin capsules compared with ibuprofen tablets in patients with moderate to severe postoperative dental pain.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring surgical removal of 2 ipsilateral third molars, of which the mandibular must be fully or partially impacted. The ipsilateral maxillary third molar may be of any impaction level.
- •Patients having a moderate to severe Baseline pain intensity as assessed by a score of 2 (moderate) or 3 (severe) on the 4-point categorical pain intensity VRS, confirmed by a VASPI score of ≥ 50 mm within 5 hours of surgical completion, after local anesthetic dissipation.
排除标准
- •Patients who require the removal of a single third molar, or 2 ipsilateral third molars where mandibular molar is not fully or partially impacted.
- •Patients with active peptic ulcer disease or a history of significant gastrointestinal disease or any gastrointestinal bleeding.
- •Patients with coagulation or bleeding disorders.
- •Patients with a positive drug or alcohol screen.
- •Patients who have received an anti-inflammatory agent, analgesic, sedative, hypnotic, muscle relaxant, or tranquilizer within 5 elimination half-lives before administration of study drug (other than surgical anesthetic prior to and during dental surgery).
研究组 & 干预措施
Dilcofenac potassium + placebo to Ibuprofen
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
干预措施: Diclofenac potassium (Drug)
Dilcofenac potassium + placebo to Ibuprofen
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
干预措施: Placebo to ibuprofen (Drug)
Ibuprofen + placebo to diclofenac potassium
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
干预措施: Ibuprofen (Drug)
Ibuprofen + placebo to diclofenac potassium
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
干预措施: Placebo to diclofenac potassium (Drug)
结局指标
主要结局
Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose
时间窗: 60 minutes postdose
VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled "no pain" (0 mm) as the left anchor and "worst possible pain" (100 mm) as the right anchor. A positive change represents a reduction in pain.
次要结局
- Time to Onset of Meaningful Pain Relief (MPR)(Within 8 hours postdose)
- Sum of Pain Intensity Difference (SPID)(1, 2, 4, 6, and 8 hours postdose)
- Time to Onset of First Perceptible Pain Relief (FPR)(Within 8 hours postdose)
- Duration of Analgesia(From dose administration to 8 hours post dose)
- Time to Confirmed First Perceptible Pain Relief(Within 8 hours postdose)
- Number of Patients With Different Responses Based on Patient's Global Assessment of Response to Treatment (PGART)(At 8 hour postdose prior to use of rescue medication)
- Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points(15, 30, 45, and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose)
- Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points(15, 30, 45, 60 and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose)
- Summed Total Pain Relief (TOTPAR) at Different Time Points(1, 2, 4, 6, and 8 hours postdose)
- Number of Patients Needing Rescue Medication(From dose administration to 8 hours post dose)
- Number of Patients With Any Adverse Events, Serious Adverse Events and Death(time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days))
- Peak Analgesic Effect(From dose administration to 8 hours post dose)