A Double-blind, 5 Parallel-group, Placebo-controlled, Randomised, Single Dose, 3-site Study to Compare the Analgesic Efficacy and Tolerability of a Combination of Ibuprofen 400 mg Plus Paracetamol 1000 mg; a Combination of Ibuprofen 200 mg Plus Paracetamol 500 mg; a Combination of Ibuprofen 400 mg Plus Codeine 25.6 mg (Nurofen Plus®); a Combination of Paracetamol 1000 mg Plus Codeine 30 mg (Panadeine® Extra) in Postoperative Adult Dental Pain Following Third Molar Extraction.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 678
- 试验地点
- 1
- 主要终点
- Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)
研究概览
简要总结
The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.
详细描述
RB has developed a fixed-dose combination of ibuprofen and acetaminophen (paracetamol). Since the pharmacological actions of ibuprofen and acetaminophen (paracetamol) differ in their site and mode of action, the combination would be expected to be more effective than either active alone, given that pain is multi-factorial with different mediators.
The purpose of this study was to compare the efficacy and tolerability of ibuprofen/acetaminophen (paracetamol) combination with leading market analgesics.
The efficacy and tolerability was assessed in terms of total analgesic effect, peak analgesic effect, onset and duration of action and the subject's overall assessment of the study medication.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experiencing moderate to severe pain after extraction of impacted third molars
排除标准
- •Any ongoing painful condition other than that associated with the current third molar surgery that could significantly interfere with the subject's suitability Any condition that would render the subject unsuitable to receive an NSAID, acetaminophen or codeine
研究组 & 干预措施
Ibuprofen/acetaminophen (higher dose)
Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg
干预措施: Ibuprofen/acetaminophen (higher dose) (Drug)
Ibuprofen/acetaminophen (lower dose)
One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet
干预措施: Ibuprofen/acetaminophen (Drug)
Nurofen Plus®
Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®)
干预措施: Nurofen Plus® (Drug)
Panadeine® Extra
Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra)
干预措施: Panadeine® Extra (Drug)
Placebo
Two placebo tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Area Under the Curve (AUC) of Pain Intensity and Relief Scores (SPRID)
时间窗: 0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose
SPRID 0-12h: Sum of pain intensity difference (PID) and the pain relief (PR) score over the twelve-hour follow-up period. Score range: 0mm = No pain and 100mm = Worst pain. This was calculated as the area under the curve (AUC) using the method of linear trapezoids assuming that the baseline assessment took place at time zero. Pain intensity (PI) was measured by pain assessment questionnaire, where subject tick the appropriate box in a 4-point ordinal scale ranging from 0 = No pain, 1 = Mild pain, 2 = Moderate pain, and 3 = Severe pain, in response to the question 'What is your pain level at this time?' Total Pain Relief (TOTPAR) was measured using pain assessment diary, where subject tick the appropriate box on a 5-point Ordinal Rating Scale: 0 = None, 1 = A Little, 2 = Some, 3 = A Lot, and 4 = Complete, in response to the question 'How much relief have you had from your starting pain?'
次要结局
- Change From Baseline in AUC (0-8h) of SPRID(0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose)
- Change From Baseline in AUC for Pain Intensity Difference Scores (SPID)(0-4, 0-6, 0-8 and 0-12 hours)
- Change From Baseline in AUC of Pain Relief Scores (TOTPAR)(0-4, 0-6, 0-8 and 0-12 hours)
- Change From Baseline in AUC of Individual Reading Pain Intensity and Relief Scores (SPRID)(15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours)
- Individual Pain Intensity Differences (Ordinal)(15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours)
- Individual Pain Intensity Differences Visual Analogue Scale (VAS)(15, 30, 45, 60, 90 minutes and 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 hours)
- Change From Baseline in Peak Pain Intensity Difference (Peak PID - Ordinal)(0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose)
- Change From Baseline in Peak Pain Relief (PR)(0 (baseline), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12 hours post-dose)
- Subjects' Overall Assessment of the Study Medication Assessed at 12 Hours or Just Before Administration of Rescue Medication(At 12 hours)