Comparison of the Analgesic Effect of a New Paracetamol Formulation (Paracetamol UNIFLASH) for Buccal Use and Two Different Doses of an Oral Paracetamol Form Controlled Versus Placebo in Patients Suffering From Moderate Pain Due to a Tooth Extraction.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 407
- 试验地点
- 20
- 主要终点
- Ranked Efficacy Endpoints: 1. Sum of Pain Intensity Difference (SPID0-60min)
研究概览
简要总结
This study aims to evaluate the analgesic efficacy of single dose of a new paracetamol formulation (paracetamol UNIFLASH) for buccal use in comparison to two different doses of an oral paracetamol form controlled versus placebo.
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)
盲法说明
Double-blind. Participants, Investigators, and all persons involved in the conduct, data management, and analysis of the study will be fully blind to the participant's treatment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged from 18 years of age
- •Patients scheduled to undergo the removal of one third soft-tissue impacted or not-impacted mandibular molar (associated or not to an ipsilateral erupted maxillary molar) under short-acting local anaesthetic preoperatively;
- •Patients weighing > 50 kg;
- •Additional inclusion criteria
- •Patients experiencing a moderate pain within 4 hours after the dental extraction, defined by a baseline pain intensity Visual Analogic Scale (VAS) score ≥ 40 mm and ≤ 60 mm;
- •Third mandibular molar extraction completed without any immediate complication, that in the opinion of the investigator, would interfere with the study conduct and/or assessments (e.g., suspected neurosensory complication, incomplete removal of tooth).
排除标准
- •Patient who undergoes an extraction of contralateral molar in the same procedure or a bony-impacted molar;
- •Patients treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within the 3 days prior to the day of randomization (or within 5 times the elimination half-life whichever the longest);
- •Patient who received other analgesic than short-acting preoperative or intraoperative local anaesthetic agents within 12 hours before the start of the surgery or peri-operatively until randomization;
- •Patients with any known hypersensitivity to paracetamol, ibuprofen or ingredients contained in IMPs and Non-Investigational Medicinal Product (NIMP);
研究组 & 干预措施
Paracetamol UNIFLASH 125mg
1 sachet Paracetamol UNIFLASH 125mg + 2 placebo capsule
干预措施: Paracetamol Uniflash 125mg (Drug)
Paracetamol UNIFLASH 125mg
1 sachet Paracetamol UNIFLASH 125mg + 2 placebo capsule
干预措施: Placebo (Drug)
Placebo
1 Placebo sachet + 2 placebo capsule
干预措施: Placebo (Drug)
Paracetamol 500mg
1 Placebo sachet + 1 placebo capsule + 1 capsule Panadol 500mg
干预措施: Panadol 500 MG Oral Tablet X1 (Drug)
Paracetamol 500mg
1 Placebo sachet + 1 placebo capsule + 1 capsule Panadol 500mg
干预措施: Placebo (Drug)
Paracetamol 1000mg
1 Placebo sachet + 2 capsules Panadol 500mg
干预措施: Panadol 500 MG Oral Tablet X2 (Drug)
Paracetamol 1000mg
1 Placebo sachet + 2 capsules Panadol 500mg
干预措施: Placebo (Drug)
结局指标
主要结局
Ranked Efficacy Endpoints: 1. Sum of Pain Intensity Difference (SPID0-60min)
时间窗: At 60 minutes
Pain Intensity Difference will be calculated using the scores of pain intensity assessed by the patient at defined time-points (T5, T10, T15, T20, T30, T45, T60 min) after the IMP intake and/or right before first intake of rescue medication using a 100-mm Visual Analogic Scale (0= no pain and 100= worst imaginable pain) compared to baseline
Proportion of responder patients at 60 minutes (versus 500 mg of the reference oral paracetamol (Panadol®)).
时间窗: At 60 minutes
A responder patient is defined as a subject who achieves a reduction of 50 % of pain intensity compared to baseline.
Patient Global Impression of Change (PGIC) versus 1000 mg of the reference oral paracetamol (Panadol®)
时间窗: At 60 minutes
Onset of pain relief (versus 500 mg of the reference oral paracetamol (Panadol®)
时间窗: At 60 minutes
Defined as the period for the patient to reach a meaningful pain relief during the first 60 min post-IMP intake. After completion of the 5-point verbal rating scale (VRS) at T5, T10, T15, T20, T30, T45, T60 min post-IMP intake assessment time points, the patient will have to answer this question "Do you consider this level of pain relief as meaningful - Yes or No?"
Onset of pain relief (versus 1000 mg of the reference oral paracetamol (Panadol®)).
时间窗: At 60 minutes
Defined as the period for the patient to reach a meaningful pain relief during the first 60 min post-IMP intake. After completion of the a 5-point verbal rating scale at T5, T10, T15, T20, T30, T45, T60 min post-IMP intake assessment time points, the patient will have to answer this question "Do you consider this level of pain relief as meaningful - Yes or No?"
次要结局
- Sum of Pain Intensity Difference at 5 minutes (SPID0-5min), 10 minutes (SPID0-10min), 30 minutes (SPID0-30min), 45 minutes (SPID0-45min), 1 hour (SPID0-1h), 2 hours (SPID0-2h), 4 hours (SPID0-4h), and 6 hours (SPID0-6h).(At 5 minutes, 10 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, and 6 hours.)
- Proportion of patients taking a rescue analgesic treatment.(At 6 hours)
- Proportion of responders at 60 minutes (versus 1000 mg of the reference oral paracetamol (Panadol®)).(At 60 minutes)
- Proportion of responders at 5 minutes, 10 minutes, 30 minutes, 45 minutes, 2 hours, 4 hours and then 6 hours.(At 5 minutes, 10 minutes, 30 minutes, 45 minutes, 2 hours, 4 hours and then 6 hours.)
- Patient Global Impression of Change (PGIC) versus 500 mg of the reference oral paracetamol (Panadol®)(At 60 minutes)
- Total Pain Relief at 1 hour (TOTPAR0-1h), 2 hours (TOTPAR0-2h), 4 hours (TOTPAR0-4h) and 6 hours (TOTPAR0-6h)(At 1 hour, 2 hours, 4 hours and 6 hours.)
- Period of time before taking rescue analgesic treatment intake.(Up to 24 hours after dose)
- Patient Global Impression of Change (PGIC) versus 500 mg and 1000 mg of the reference oral paracetamol (Panadol®)(At 360 minutes)