Maxigesic 325 Acute Dental Pain Study: A Double-blind, Placebo-controlled, Randomized, Parallel Group Comparison of the Effects of Maxigesic 325 Versus Acetaminophen, Ibuprofen and Placebo in Participants With Acute Dental Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 408
- 试验地点
- 4
- 主要终点
- SPID (Summed Pain Intensity Differences)
研究概览
简要总结
The purpose of this study is to determine whether the analgesic effects of Maxigesic USA are greater than acetaminophen, ibuprofen or placebo.
详细描述
The combination of 500mg acetaminophen and 150mg ibuprofen has been shown to improve analgesia compared with the individual components, when given as 2 tablets (i.e. total of 1,000/300 mg) 4 times a day.
Recent concerns over the safety of acetaminophen have led to some regulatory agencies restricting the maximum dose of acetaminophen per tablet to 325 mg, while maintaining the maximum daily dose of 4000mg per day.
A dosing regimen of three tablets of Maxigesic 325 four times a day gives a total daily dose of 3900mg acetaminophen and 1170mg ibuprofen.
The primary objective of the study is to compare time-adjusted SPID of the VAS pain intensity scores up to 48 hours after the first dose of study medication among the four study groups.
Secondary objectives are:
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provides written informed consent before initiation of any study-related procedures.
- •Males and females aged at least 10 years and not more than 60 years old on the day of consent.
- •Undergoing dental surgery for the extraction of at least 2 impacted third molar teeth.
- •A resting VAS pain intensity score at baseline (within 6 hours after the completion of surgery) of greater than or equal to 40 mm on a 100 mm VAS scale with 0 = no pain and 100 = worst pain imaginable.
排除标准
- •Has taken any NSAID or acetaminophen within 12 hours prior to the stat of surgery other than asprin less than or equal to 150 mg/day
- •Subjects who have received any anaesthetics within 24 hours prior to surgery
- •Hypersensitivity to opioids
- •Known to be pregnant or possibly pregnant
- •Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A women of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral oophorectomy.
- •Women of childbearing potential who are unwilling to undergo an urine pregnancy test.
- •Suffering from a neurological disorder relating to pain perception or any acute or chronic condition that, in the opinion of the investigator, makes the subject unsuitable from an efficacy or safety perspective.
- •In the opinion of the investigator, unable to understand the visual analogue pain score or comply with the protocol requirements.
- •Currently, or in the last 30 days, has been in a clinical trial involving another study drug.
- •Currently treated with an ACE inhibitor, warfarin, steroid (other than nasal steroids or topical steroids with the approval of the investigator) cyclosporin, tacrolimus or methotrexate, or any other medication felt by the investigator to interfere with safety or efficacy evaluations.
- •Participant weight < 50 kg or > 120 kg.
- •Has a history of drug or alcohol abuse.
- •Suffering from any other disease or condition which, in the opinion of the investigator, means that it would not be in the participants best interests to participant in the study.
研究组 & 干预措施
Maxigesic 325
Acetaminophen 325mg + ibuprofen 97.5mg per tablet, two tablets every 6 hours, orally
干预措施: Maxigesic 325 (Drug)
Acetaminophen
Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally
干预措施: Acetaminophen (Drug)
Ibuprofen
Ibuprofen 97.5mg per tablet (i.e. low dose ibuprofen), two tablets every 6 hours, orally
干预措施: Ibuprofen (Drug)
Placebo
Placebo tablets, every 6 hours, orally
干预措施: Placebo (Drug)
结局指标
主要结局
SPID (Summed Pain Intensity Differences)
时间窗: 48 hours afte the first dose
The time-adjusted Summed Pain Intensity Differences (SPIDs) of the VAS pain intensity scores up to 48 hours after the first dose of study medication. This was calculated from the visual analogue scale (VAS) pain intensity scores recorded during the 48 hours double blind treatment period, with the last measure taken just prior to the final dose of blinded study medication. The visual analogue scale is 100mm long with 0= no pain and 100=worst pain imaginable. The Visual Analogue Scale It is expected that treatments which can provide superior analgesic effect will demonstrate a greater Summed Pain Intensity Difference.
次要结局
未报告次要终点