A Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Nasal CO2 in the Symptomatic Treatment of Temporomandibular Disorders
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Capnia, Inc.
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in pain status from baseline over a 3 hour period
研究概览
简要总结
This purpose of this study is to evaluate the safety and efficacy of treatment with nasal CO2 in the treatment of pain and other symptoms related to temporomandibular disorder (TMD).
详细描述
This is a randomized, controlled trial evaluating the safety and efficacy of nasal carbon dioxide for the treatment of pain and other symptoms related to temporomandibular disorders (TMD). Approximately 115 men and women ages 18 to 70 years old who have a history consistent with TMD-related pain for at least 3 months and meet all other eligibility criteria will be enrolled in this study. There may be up to two (2) visits to the clinic, screening and treatment. Screening and treatment may occur on the same day.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a history consistent with TMD-related pain for at least 3 months prior to screening
- •Agree not to use certain medications prior to randomization within the study specified
- •Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test.
排除标准
- •Have recent history of alcohol or drug abuse within 2 years prior to randomization
- •Current major psychiatric disorder such as suicidal ideation, bipolar, panic disorder, schizophrenic, or psychoses
- •History of asthma (other than mild or intermittent)
- •Have an existing serious unstable systemic disease (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study
- •Clinically significant nasal disorder (such as deviated septum, presence of polyps, evidence of significant congestion, rhinitis, or other nasal abnormalities)
- •Current diagnosis of fibromyalgia
- •History or clear clinical evidence of osteoarthritis of temporomandibular joint (TMJ)
- •A TMD diagnosis of disc displacement without reduction, "locking"
研究组 & 干预措施
1
Nasal Carbon Dioxide
干预措施: Nasal Carbon Dioxide (Drug)
2
Air
干预措施: Air (Other)
结局指标
主要结局
Change in pain status from baseline over a 3 hour period
时间窗: within 3 hours of the first dose
次要结局
未报告次要终点