NCT01118273已完成4 期
A Double-Blind, Randomized, Pilot Study Assessing the Analgesic and Hypnotic Effect of Naproxen Sodium and Diphenhydramine Combination in Dental Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 162
- 主要终点
- Total Sleep Time Measured by Actigraphy
研究概览
简要总结
The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination
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
- Triple (Participant, Care Provider, Investigator)
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
- 否
入选标准
- •Healthy, ambulatory, male and female volunteers between 16-45 years of age;
- •Scheduled to undergo surgical removal of 1 to 3 impacted third molars, one of which must be at least a partial bony mandibular impaction;
- •Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of >/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale by 2030 h +/- 15 minutes on the day of surgery;
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g. oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy;
- •Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects <18 years of age must sign a written assent and have parental or guardian consent).
排除标准
- •History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal antiinflammatory drugs (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the products;
- •Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
- •Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator;
- •Current or past history of bleeding disorder(s);
- •Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator;
- •Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months;
- •Positive alcohol breathalyzer test and negative urine drug test prior to surgery;
- •Females who are pregnant or lactating;
- •Chronic or severe sleep problems that do not respond to Over the counter (OTC) medication and requires a prescription hypnotic or sedative;
研究组 & 干预措施
Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg
Experimental
干预措施: Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg (Drug)
Naproxen Sodium 440 mg (BAYH6689)
Active Comparator
干预措施: Naproxen Sodium 440 mg (BAYH6689) (Drug)
Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg
Experimental
干预措施: Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg (Drug)
Naproxen Sodium 220 mg (BAYH6689)
Active Comparator
干预措施: Naproxen Sodium 220 mg (BAYH6689) (Drug)
DPH 50mg
Active Comparator
干预措施: DPH 50mg (Drug)
Ibuprofen 400 mg / Diphenhydramine citrate 76 mg
Active Comparator
干预措施: Ibuprofen 400 mg / Diphenhydramine citrate 76 mg (Drug)
结局指标
主要结局
Total Sleep Time Measured by Actigraphy
时间窗: Up to 10 hours
Actigraphy is a non-intrusive tool that measures an individual's movement during sleep. Actigraphy was used to obtain data in discriminating between sleep and wake states in the subjects. In calculating the total sleep time, subjects who took rescue medication were treated as "awake" from the time the rescue medication was given until the end of the sleep period. In addition, if subjects rescued before sleep onset, their total sleep time was set to zero.
次要结局
- Global Assessment of Study Medication as a Sleep-aid(Up to 10 hours)
- Karolinska Sleep Diary - Sleep Quality(Up to 10 hours)
- Karolinska Sleep Diary - Calmness of Sleep(Up to 10 hours)
- Karolinska Sleep Diary - Easiness to Fall Asleep(Up to 10 hours)
- Karolinska Sleep Diary - Premature Awakening(Up to 10 hours)
- Wake After Sleep Onset (WASO) Measured by Actigraphy(Up to 10 hours)
- Karolinska Sleep Diary - Ease of Awakening(Up to 10 hours)
- Sleep Latency Measured by Actigraphy(Up to 10 hours)
- Karolinska Sleep Diary - Well Rested(Up to 10 hours)
- Karolinska Sleep Diary - Sufficient Sleep(Up to 10 hours)
- Total Sleep Time by Subject Assessment(Up to 10 hours)
- Sleep Quality Index(Up to 10 hours)
- Overall Rating of Severity in Categorical Pain Rating Scale Score(Up to 10 hours)
- Change From Baseline in Categorical Pain Rating Scale Score(Baseline and up to 10 hours)
- Overall Rating of Severity in Visual Analog Scale (VAS) Score(At 10 hours)
- Change From Baseline in Visual Analog Scale (VAS) Score(Baseline and up to 10 hours)
- Overall Rating of Pain Relief(Up to 10 hours)
- Time to Rescue Medication(Up to 10 hours)
- Cumulative Proportion of Participants Taking Rescue Medication by Hour(Up to 10 hours)
- Global Assessment of Study Medication as a Pain Reliever(Up to 10 hours)
- Number of Times Participants Took Rescue Medication(Up to 10 hours)
- Total Wake Time Measured by Actigraphy(Up to 10 hours)
- Sleep Efficiency Measured by Actigraphy(Up to 10 hours)
- Activity Mean Measured by Actigraphy(Up to 10 hours)
- Wake Episode Measured by Actigraphy(Up to 10 hours)
研究者
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