A Phase III, Randomized, Active-Comparator-Controlled, 2-period, Crossover, Double-Blind Study in China to Assess the Safety and Efficacy of Etoricoxib 120 mg Versus Ibuprofen up to 2400 mg (600 mg Q6h) in the Treatment of Patients With Primary Dysmenorrhea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 139
- 主要终点
- Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose
研究概览
简要总结
This is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.
详细描述
Participants who meet all the study entry criteria will be randomly allocated to 2 possible sequences of the 2 treatment regimens over the course of 2 menstrual cycles.
In treatment sequence 1, participants will receive etoricoxib 120 mg daily in menstrual cycle 1, and ibuprofen up to 2400 mg/daily in menstrual cycle 2. In treatment sequence 2, participants will receive ibuprofen up to 2400 mg/daily in menstrual cycle 1 and etoricoxib 120 mg daily in menstrual cycle 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Agree to remain abstinent or use double-barrier contraception throughout the study. Participants who are status post tubal ligation are exempt from this requirement.
- •Moderate or severe primary dysmenorrhea during a minimum of 4 of the previous 6 menstrual cycles. Moderate: Over-the-counter analgesics provide significant relief in most menstrual cycles; discomfort interferes with usual activity. Severe: Over-the-counter analgesics not consistently effective, or prescription analgesics required in at least some menstrual cycles; discomfort is incapacitating causing an inability to work or do usual activity.
- •Willing to limit alcohol intake to 2 drinks or equivalent per day for the duration of the study and follow-up period as well as to avoid exercise during the first 24 hours postdose in each menstrual cycle.
- •Able to read, understand, and complete diary.
排除标准
- •Use of an intrauterine device. Pregnant, breast feeding, or <6 weeks postpartum.
- •Active gastric ulcer or history of inflammatory bowel disease.
- •Uncontrolled hypertension.
- •Uncontrolled diabetes mellitus or renal disease.
- •Class II-IV congestive heart failure.
- •Coronary artery bypass graft surgery, angioplasty, myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months.
- •Unstable angina.
- •Mild, moderate, or severe hepatic insufficiency.
- •Any personal or family history of an inherited or acquired bleeding disorder.
- •History of neoplastic disease; Exceptions: 1)adequately treated basal cell carcinoma or carcinoma in situ of the cervix; 2) other malignancies which have been successfully treated > or equal to 5 years prior to screening. Participants with a history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease are ineligible for the study regardless of the time since treatment.
- •Allergic to etoricoxib, ibuprofen, acetaminophen, indomethacin, or other nonsteroidal anti-inflammatory drugs (NSAIDs), or cyclooxygenase (COX)-2 inhibitors, or to components in Saridon (propyphenazone/paracetamol/caffeine).
- •Recent history of chronic analgesic or tranquilizer use or dependence.
- •Morbidly obese and demonstrates significant health problems stemming from the obesity.
- •Current user of recreational or illicit drugs or had a recent history of drug or alcohol abuse or dependence.
- •Participated in another clinical study within the last 4 weeks.
- •Not able to swallow oral medications: surgical or anatomical conditions that will preclude from swallowing and absorbing oral medications on an ongoing basis.
研究组 & 干预措施
Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen
Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.
干预措施: Etoricoxib (Drug)
Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen
Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.
干预措施: Ibuprofen (Drug)
Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen
Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.
干预措施: Placebo to etoricoxib (Drug)
Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen
Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.
干预措施: Placebo to ibuprofen (Drug)
Etoricoxib+placebo ibuprofen then placebo etorcoxib+ibuprofen
Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.
干预措施: Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Drug)
Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen
Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.
干预措施: Etoricoxib (Drug)
Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen
Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.
干预措施: Ibuprofen (Drug)
Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen
Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.
干预措施: Placebo to etoricoxib (Drug)
Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen
Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.
干预措施: Placebo to ibuprofen (Drug)
Ibuprofen+placebo etoricoxib then etoricoxib+placebo ibuprofen
Participants will receive one tablet (active or placebo etoricoxib) and 3 capsules (active or placebo ibuprofen) as their first dose of study medication in Cycle 1 and Cycle 2. They can also take 3 capsules (active or placebo ibuprofen) up to 3 times more per day in Cycle 1 and Cycle 2.
干预措施: Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg (Drug)
结局指标
主要结局
Total Pain Relief Score Over the First 6 Hours (TOPAR6) After the Initial Dose
时间窗: Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours
TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24, with increasing scores indicating greater pain relief.
次要结局
- Sum of Pain Intensity Difference Scores Over the 6-Hour Time Period (SPID6)(Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours)
- Mean Participant Global Evaluation of Pain at 6 Hours After the Initial Dose (GLOBAL6)(6 hours)
- Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 6 Hours After the Initial Dose(6 hours)
- Mean Time to >=1 Unit Improvement From Baseline in Pain Intensity During the 6 Hours After the Initial Dose(Baseline and 6 hours)
- Peak Pain Intensity Difference (PID) During the 6 Hours After the Initial Dose(Baseline and 0.5, 1, 1.5, 2, 3, 4, 5 and 6 hours)
- Peak Pain Relief (Peak PR) During the 6 Hours After the Initial Dose(Up to 6 hours)
- Number of Participants Using Rescue Medication 24 Hours After the Initial Dose(24 Hours)
- Number of Participants With a Global Evaluation of Study Medication of Good, Very Good, or Excellent at 24 Hours After the Initial Dose(24 Hours)
- Mean Participant Global Evaluation of Pain at 24 Hours After the Initial Dose (GLOBAL24)(24 hours)
- PR at Up to 24 Hours Following the Initial Dose(Up to 24 hours)
- PID at Up to 12 Hours Following the Initial Dose(Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 and 12 hours)
- PR at Up to 12 Hours Following the Initial Dose(Up to 12 hours)
- PID at Up to 24 Hours Following the Initial Dose(Baseline and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 20 and 24 hours)