NCT00474175已完成4 期
Benzocaine Gel Toothache Dose-Response Study
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 577 人开始时间: 2007年5月最近更新:
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
- 入组人数
- 577
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Response
研究概览
简要总结
To evaluate the efficacy and safety of benzocaine gel products for the relief of toothache and to assess the subject's compliance with proposed label directions.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females at least 12 years of age.
- •Presence of spontaneous toothache pain in only one permanent tooth. Toothache pain is due only to an open tooth cavity and only as a result of dental caries, loss of a restoration or tooth fracture.
- •To qualify for the study, the subject must have a rating of at least moderate pain on the Dental Pain Scale (DPS) and a score of at least 50 mm on the Visual Analog Scale. To be included in the moderate pain stratum, the subjects must have a rating of moderate pain in the DPS and to be included in the severe pain stratum the subjects must have a rating of severe pain in the DPS.
- •Females who are neither pregnant, as verified by a urine-based pregnancy test, nor breast-feeding.
- •Female subjects of childbearing potential and those who are post-menopausal for less than 2 years must be using a medically approved method of contraception (i.e., oral, transdermal or implanted contraceptive devices, intrauterine device, diaphragm, condom, abstinence, or surgical sterility).
- •Subjects must be reliable, cooperative and of adequate intelligence to read and understand the rating scales and other study instructions.
- •Subjects must be able to read, comprehend, and sign the consent form. Minors will provide assent to study participation if age appropriate. Parent/legal guardian must be able to read, comprehend, and sign the informed consent form.
排除标准
- •Presence of spontaneous toothache pain in a primary tooth. Presence of spontaneous toothache pain in more than one tooth. Presence of an open tooth cavity in a tooth adjacent to the painful tooth with the open tooth cavity.
- •Presence of concomitant oral pain due to any other condition such as: soft-tissue lesions (e.g., aphthous or traumatic ulcer, herpes labialis, acute necrotizing ulcerative gingivitis); or multiple hard-tissue (e.g., carious) lesions; pain due to other surgical procedures, injuries or dental surface sensitivity.
- •Presence of a periodontal abscess as diagnosed from an X-ray or clinical examination of the painful tooth.
- •Presence of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- •History of acute or chronic hemolytic anemia.
- •History of sensitivity or allergy to benzocaine or other local anesthetic agents.
- •Use of any short-acting oral or topical analgesic/ anesthetic product within 2 hours of enrollment or any long-acting Rx or OTC analgesic product within 4 hours of enrollment.
- •Use of an investigational drug or participation in an investigational study within the past 30 days.
- •Previous participation in this study.
- •Member or a relative of the study site staff or sponsor directly involved in the study.
研究组 & 干预措施
1
Placebo Comparator
Placebo control
干预措施: Placebo gel (Drug)
2
Active Comparator
10% benzocaine gel formulation
干预措施: benzocaine (Drug)
3
Active Comparator
20% benzocaine gel formulation
干预措施: benzocaine (Drug)
结局指标
主要结局
Percentage of Participants With a Response
时间窗: Baseline, 5, 10, 15 and 20 minutes
Responder was defined as participant experiencing improvement in pain intensity, as exhibited by a pain score reduction on the Dental Pain Scale (DPS) from baseline of at least 1 unit for two consecutive assessments anytime between the 5 and 20-minute time points. Response in DPS scale was assigned values as 0 (None), 1 (Mild), 2 (Moderate) and 3 (Severe).
次要结局
- Time to First Confirmed Perceptible Relief(0 to 120 minutes)
- Time to Meaningful Relief(0 to 120 minutes)
- Duration of Effect(0 to 120 minutes)
- Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores(60 minutes and 120 minutes)
- Time to Dropping Out Due to Lack of Efficacy or Rescue Medication(0 to 120 minutes)
- Pain Relief Combined With Pain Intensity Difference (PRID) Scores(5 to 120 minutes)
- Global Satisfaction Assessment(120 minutes)
研究者
研究点 (1)
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