Ibuprofen 600 mg Extended-Release (ER) Multiple-Dose Dental Pain Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth.
详细描述
This is a single-center, multiple-dose, randomized, placebo-controlled, double-blinded, parallel group trial to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth. The surgery will consist of surgical extraction of 1-2 impacted third molars, of which one must be a mandibular impaction that is partially impacted in either tissue or bone. Subjects will be stratified according to baseline pain intensity, as rated on an 11-point pain intensity numerical rating scale (PI-NRS)and gender.
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 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 16 to 45 years of age;
- •Outpatients scheduled to undergo surgical extraction of 1-2 impacted third molar(s), one of which must be a mandibular impaction that is partially impacted in either tissue or bone;
- •At least a score of 5 on the 11-point pain intensity numerical rating scale (PI-NRS) at baseline;
- •Use of only the following preoperative medication(s) / anesthetic(s): short-acting local anesthetic (e.g., mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide;
- •Reliable, cooperative, and adequate intelligence to record the requested information on the analgesic questionnaire form;
- •Subjects (or the parent or legal guardian of subjects under the age of 18 years) are required to read, comprehend, and sign the informed consent. Subjects requiring a parent or legal guardian to sign the informed consent will be required to sign an assent;
- •Examined by the attending dentist or physician and medically cleared to participate in the study; and,
- •In general good health and have no contraindications to any of the study meds.
排除标准
- •Presence of a serious medical condition (e.g., poorly controlled hypertension, poorly controlled diabetes, significantly impaired cardiac, renal or hepatic function, hyper- or hypothyroidism);
- •Use of a prescription or nonprescription drug with which the administration of ibuprofen, celecoxib, any other non-steroidal anti-inflammatory drug (NSAID), or acetaminophen, is contraindicated;
- •Acute local infection at the time of surgery that could confound the post-surgical evaluation;
- •Females who are pregnant, lactating, of child-bearing potential, or postmenopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test;
- •Presence or history (within 2 years of enrollment) of bleeding disorder(s) or peptic ulcer disease;
- •Presence or history (within the past year) of alcoholism or substance abuse. Subjects who are taking CNS or other psychotropic drugs (including St. John's Wort, or any other nutritional supplement known to have psychotropic effects) may be enrolled if they have been on stable doses of medication for at least 2 months, will maintain this dose throughout the study, and their condition is judged by the Principal Investigator to be well-controlled;
- •Habituation to analgesic drugs (i.e., routine use of oral analgesics 5 or more times per week);
- •History of allergic reaction (eg, asthma, rhinitis, swelling, shock, or hives) to ibuprofen, naproxen, aspirin, celecoxib, any other NSAID, or acetaminophen;
- •Prior use of any type of analgesic or NSAID 5 half-lives of that drug or less before taking the first dose of study medication, except for pre-anesthetic medication and anesthesia for the procedure;
- •Ingestion of any caffeine-containing beverages, chocolate, or alcohol 4 hours or less before taking the first dose of study medication;
- •Has taken an investigational product within the past 30 days;
- •Has previously been entered into this study; and,
- •The subject is a member of the study site staff either directly involved with the study, an employee of the Sponsor, or a relative of study site personnel directly involved with the study or Sponsor.
研究组 & 干预措施
Ibuprofen 600 mg ER group
One-hundred and sixty subjects will be randomly assigned to the Ibuprofen 600 mg ER treatment group based on gender and baseline pain intensity, as rated on an 11-point numerical rating scale (PI-NRS; 5-7 moderate pain, or 8-10, severe pain).
干预措施: Ibuprofen 600 mg Extended-Release Tablets (Drug)
Placebo group
Eighty subjects will be randomly assigned to the Placebo treatment group based on gender and baseline pain intensity, as rated on an 11-point numerical rating scale (PI-NRS; 5-7 moderate pain, or 8-10, severe pain).
干预措施: Placebo (Drug)
结局指标
主要结局
Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale
时间窗: from baseline to 12 hours after dose 1
Analgesic efficacy for the 8-12 hour measurement interval after dose 1 using Sum of Pain Intensity Differences (SPID). An 11-point Pain Intensity Numerical Rating Scale (PI-NRS) was used to record pain intensity at baseline and 8, 9, 10, 11, 12 hours after dose 1. The scale went from 0 (no pain) to 10 (Worst possible pain). The outcome measure is based a mean of the sum of each of the five time points evaluated. The total time scale ranges from 0 to 50. Subjects were asked to select the number that best describes how much pain they had at the time of observation.
Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours
时间窗: 24, 36, and 48 hours
Response rate measured the durability of effect and was measured by the number of subjects achieving a reduction of at least 2 points (greater than or equal to 20%) from baseline on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at all 3 assessment periods of 24, 36 and 48 hours. The scale went from 0 (no pain) to 10 (Worst possible pain). Subjects were asked to select the number that best describes how much pain they had at the time of observation.
次要结局
- Time to Confirmed "First Perceptible" Relief(Within 4 hours post Dose 1)
- Time to Confirmed "Meaningful" Relief(Within 4 hours post Dose 1)
- Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1(Within 1 hour of Dose 1)
- Percentage of Subjects Achieving "Meaningful" Relief as Indicated by the Time Recorded on the Second Stopwatch Following "First Perceptible" Relief(Within 4 hours post Dose 1)
- Analgesic Efficacy for the 0-12, 0-4, 4-8, and 4-12 Hour Dosing Intervals After Dose 1 Using Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference(SPID)(0-12 hours after Dose 1)
- Duration of Relief After Dose 1(Time to rescue or time of Dose 2 (up to 12 hours following dose 1))
- Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1(0-12 hours after taking Dose 1)
- Pain Relief and PID Scores at Individual Time Points for Dose 1(24, 36, 48 hours after taking Dose 1)
- Global Evaluation for Dose 1(At 12 hours after Dose 1 or at time of rescue)
- Global Evaluation, Maximum Relief, and Overall Relief for Dose 2(At 24 hours or at time of rescue between 12 and 24 hours)
- Global Evaluation, Maximum Relief, and Overall Relief for Dose 3(At 36 hours or at time rescue between 24 and 36 hours)
- Global Evaluation, Maximum Relief, and Overall Relief for Dose 4(At 48 hours or at time of rescue between 36 and 48 hours.)