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 Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 3
- 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 adults.
详细描述
The study will employ a multi-center, randomized, double-blind, placebo-controlled, parallel-groups design to assess the safety and efficacy of Kovacaine Mist delivered intranasally for inducing pulpal anesthesia of maxillary teeth numbers 4 to 13 (maxillary right second premolar to maxillary left second premolar) sufficient to allow completion of the Study Dental Procedure. The maxillary teeth will be categorized in two subsets, anteriors (teeth numbers 6 to 11) and premolars (teeth numbers 4, 5, 12 and 13).
The intent is to treat 150 subjects at 3 study sites, 2:1 randomization within each study site, and an overall goal of 100 subjects treated with Kovacaine Mist and 50 treated with placebo. Recruitment will be from diverse dental patient populations with at least 25% of subjects over 50 years of age. Randomization will be within strata defined by age (≤50 and >50 years).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 years of age or older.
- •Need for an operative restorative dental procedure requiring local anesthesia for a single vital maxillary tooth (anterior or premolar tooth #4 to #13) with no evidence of pulpal pathology.
- •Normal lip, nose, eyelid, and cheek sensation.
- •Able to understand and sign the study informed consent document, communicate with the Investigators, and understand and comply with the requirements of the protocol.
- •Patency of the naris ipsilateral to the tooth undergoing the Study Dental Procedure (the treatment tooth).
- •Resting heart rate (HR) between 55 and 100 beats per minute (bpm), inclusive.
- •Seated systolic blood pressure (SBP) between 95 and 150 mm Hg, inclusive, and seated diastolic blood pressure (DBP) between 60 and 100 mm Hg, inclusive.
排除标准
- •Inadequately controlled hypertension (blood pressure greater than 150/100 mm Hg).
- •Inadequately controlled active thyroid disease of any type.
- •Frequent nose bleeds (≥ 5 per month).
- •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 articaine, 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 take a urine pregnancy test on the day of, but prior to, study drug administration to rule out pregnancy.)
- •Having received any investigational drug and/or participation in any clinical trial within the 30 days prior to study participation.
- •History of congenital or idiopathic methemoglobinemia.
研究组 & 干预措施
Kovacaine Mist
Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
干预措施: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% (Drug)
Placebo
Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.
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: 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 (≤50 and >50 Years)(at 15 minutes (+3 minute window) or 25 minutes (+3 minute window) if third intranasal spray is used)
- Number of Participants With a Heart Rate Higher Than 125 Bpm(at any time within 120 minutes following drug administration)
- Number of Participants With a Heart Rate Lower Than 50 Bpm(at any time within 120 minutes following drug administration)
- Number of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and/or to a Value Higher Than 160 mm Hg(at any time within 120 minutes following drug administration)
- Number of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Lower Than 90 mm Hg(at any time within 120 minutes following study drug administration)
- Number of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and/or to a Value Higher Than 105 mm Hg(at any time within 120 minutes following study drug administration)
- Number of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 10 mm Hg and/or to a Value Lower Than 50 mm Hg(at any time within 120 minutes following study drug administration)
- Maximum Change From Baseline in Heart Rate(from baseline to 120 minutes following drug administration)
- Maximum Change From Baseline in Systolic Blood Pressure(from baseline to 120 minutes following drug administration)
- Maximum Change From Baseline in Diastolic Blood Pressure(from baseline to 120 minutes following drug administration)
- The Profile Over Time of Heart Rate(from baseline to 120 minutes following drug administration)
- Alcohol Sniff Test(administered at approximately 24 hours after drug administration)
- The Profile Over Time of Systolic Blood Pressure(from baseline to 120 minutes following drug administration)
- The Profile Over Time of Diastolic Blood Pressure(from baseline to 120 minutes following drug administration)