Ibuprofen 600 Mg Immediate Release/Extended Release (IR/ER) Caplet Self-selection, Safety And Compliance Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,083
- 试验地点
- 17
- 主要终点
- Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours
研究概览
简要总结
A self-selection and actual use trial to evaluate the extent to which consumers will appropriately select and use the 600 mg immediate release/extended release caplets and comply with dosing instructions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 12 years of age
- •use of at least 5 doses per month of over-the-counter pain relievers over the past 3 months
- •provide written informed consent (subjects 12-<18 years of age provide a written assent and parent/guardian will provide written informed consent)
- •capable of and willing to swallow the study medication
排除标准
- •participated in other research studies in the last 6 months
- •they or someone else in their household work for a pharmaceutical company, is a relative of study site personnel involved with the study, or an immediate family member is already enrolled in the study
- •have a history of known allergies to ibuprofen, aspirin, or other NSAIDs
- •have a history of heart surgery in the last 60 days or planned heart surgery in the next 60 days
- •female subjects are pregnant or breast feeding
研究组 & 干预措施
Ibuprofen 600 mg Immediate Release/Extended Release Caplet
干预措施: Ibuprofen 600 mg Immediate Release/Extended Release Caplet (Drug)
结局指标
主要结局
Percentage of Participants Who Select to Use Ibuprofen 200 mg IR Medication With a Typical Pain Duration of Greater Than or Equal to (>=) 6 Hours
时间窗: Day 1
Percentage of participants with selection of Ibuprofen 200 mg IR medication with a typical duration of pain \>=6 hours were reported in this outcome measure. These participants were classified as ''missed opportunity'' cases.
Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 Milligram (mg) Immediate Release (IR) or Extended Release (ER) Study Medication
时间窗: Day 1
Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of less than (\<) 6 hours, if left untreated.
Percentage of Participants Who Correctly Select to Use or Correctly De-select Not to Use Ibuprofen 600 mg IR/ER Study Medication Excluding Those Classified as Missed Opportunity
时间窗: Day 1
Participants as correct selectors included all participants who selected Ibuprofen 600 mg IR/ER medication with the last episode of pain of \>=6 hours, if left untreated. Participants as correct de-selectors included all participants who either selected Ibuprofen 200 mg or selected 'neither' with a typical pain duration of \<6 hours, if left untreated. Participants were classified as "missed opportunity" cases when they selected the Ibuprofen 200 mg IR medication with their typical duration of pain \>=6 hours.
Percentage of Participants Who Select to Use Ibuprofen 600 mg IR/ER Medication With a Typical Pain Duration of Less Than (<) 6 Hours
时间窗: Day 1
Percentage of participants with correct selection of Ibuprofen 600 mg IR/ER medication with a typical duration of pain \<6 hours were reported in this outcome measure.
Percentage of Participants With the Use of Study Medication For Greater Than (>) 10 Days With an Average Daily Dose of Greater Than (>) 1600 mg
时间窗: Day 1 up to Day 30
Percentage of participants with the use of study medication for \>10 days with an average daily dose of \>1600 mg were reported in this outcome measure.
Percentage of Participants With the Use of Study Medication For Less Than or Equal to (<=) 10 Days and Use More Than 20 Tablets With an Average Daily Dose of Greater Than (>) 1600 mg
时间窗: Day 1 up to Day 30
Percentage of participants who used the study medication for \<=10 days and used more than 20 tablets with an average daily dose of \>1600 mg were reported in this outcome measure.
次要结局
- Average Daily Dose of Study Medication(Day 1 up to Day 30)
- Number of Dosing Days Among Inappropriate Users(Day 1 up to Day 30)
- Maximum Daily Dose of Study Medication(Day 1 up to Day 30)
- Average Daily Dose Among Excessive Users(Day 1 up to Day 30)
- Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram Excluding Treatment of Severe Symptoms(Day 1 up to Day 30)
- Number of Pain Episodes Treated With Single Dose or Multiple Dose Among Inappropriate Users(Day 1 up to Day 30)
- Number of Treatment Days Exceeding the Daily Dose of 1200 Milligram(Day 1 up to Day 30)
- Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram(Day 1 up to Day 30)
- Number of Dosing Occasions Exceeding the Single Dose of 600 Milligram Excluding Treatment of Severe Symptoms(Day 1 up to Day 30)