A Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Groups Clinical Trial Comparing The Efficacy And Safety Of Intranasally Administered Kovacaine Mist To Placebo For Anesthetizing Maxillary Teeth In Pediatric Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
研究概览
简要总结
The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in pediatric patients.
详细描述
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to demonstrate the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary permanent teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) or maxillary primary teeth numbers A to J (maxillary right second primary molar to maxillary left second primary molar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will be categorized in two subsets, anterior teeth (permanent teeth numbers 6 to 11 and primary teeth numbers C to H) and posterior teeth (permanent teeth numbers 4, 5, 12, 13 and primary teeth numbers A, B, I, J).
The intent is to treat 90 male and female subjects aged 3 to 17 years, inclusive, at 3 study sites, 2:1 randomization within each study site, and an overall goal of 60 subjects treated with Kovacaine Mist and 30 treated with placebo. Subjects will receive Kovacaine Mist or placebo (2:1) according to the kit randomization plan within three dosing strata (100 µL, 200 µL or 400 µL) based on subject weight at entry: subjects weighing 10 to <20 kg, 20 to <40 kg and ≥ 40 kg will be assigned to the 100 µL, 200 µL or 400 µL dose group, respectively. Recruitment will be from diverse pediatric dental patient populations. To ensure adequate representation in the 3 dose/weight groups, each stratum will contain at least 25% of subjects.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 3-17 years of age inclusive.
- •Need for an operative restorative dental procedure and requiring local anesthesia on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), with no evidence of pulpal pathology.
- •Normal lip, nose, eyelid, and cheek sensation.
- •Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
- •Subject able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation).
- •Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol.
- •Patency of the naris on the same side as the tooth undergoing the Study Dental Procedure (the Study Treatment Tooth).
排除标准
- •Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
- •History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
- •History of allergy or hypersensitivity to lidocaine, oxymetazoline, epinephrine, or sulfite preservatives.
- •Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
- •Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to undergo urine testing on the day of, but prior to, study drug administration to rule out pregnancy.)
- •Inadequately controlled thyroid disease of any type.
- •Having received any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation.
- •Frequent nose bleeds (≥ 5 per month).
- •History of congenital or idiopathic methemoglobinemia.
- •Presence of an upper respiratory infection and/or fever defined as body temperature ≥100.4° (38°C) on the day of and prior to study drug administration.
研究组 & 干预措施
Kovacaine Mist
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
干预措施: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% (Drug)
Placebo
Placebo - Subjects weighing more than 10kg and less than 20kg, will receive 1 spray of 100µL; Subjects weighing more than 20kg and less than 40kg, will receive 2 sprays of 100µL (200µL total); subjects weighting more than 40kg will receive 2 sprays of 200µL (400µL total);
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.
时间窗: 100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window
If the participant does not have sufficient anesthesia to complete the Study Dental Procedure, the participant is given a rescue injection of local anesthetic and is considered a failure for this outcome.
次要结局
- Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive).(100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window)
- Maximum Change From Baseline in Heart Rate(from baseline to 24 hours following drug administration)
- Incidence of Adverse Events (AEs) by Dosage Cohort(from baseline to 24 hours following drug administration)
- Incidence of Adverse Events (AEs) by Age Group(from baseline to 24 hours following drug administration)
- Results of Naris Examination (NE) - Patency and Ulcerations(120 minutes post drug administration)
- Results of Naris Examination (NE) - Color(120 minutes post drug administration)
- Results of Naris Examination (NE) - Bleeding(120 minutes post drug administration)
- Maximum Change From Baseline in Diastolic Blood Pressure(from baseline to 24 hours following drug administration)
- Results of Naris Examination (NE) - Inflammation(120 minutes post drug administration)
- Maximum Change From Baseline in Systolic Blood Pressure(from baseline to 24 hours following drug administration)
- Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort.(100µL dose - at 10 minutes, +3 minute window; for subjects who receive the 200µL or 400µL dose - at 15 minutes, +3 minute window)