A Phase 4, Multicenter, Randomized, Double-Blinded, Controlled Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- Nerve injury
研究概览
简要总结
The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.
详细描述
This Phase 4 clinical study is designed as a multicenter, randomized, double-blinded, controlled study to evaluate the safety and efficacy of OraVerse in approximately 150 children 2 to 5 years of age. OraVerse or sham injection is administered at the completion of a dental procedure requiring local anesthesia with lidocaine 2% with 1:100,000 epinephrine. The dental procedure(s) comprising restoration/fillings shall be performed in a single quadrant of the mouth.
The primary endpoint is safety and tolerability of OraVerse as measured by adverse events, vital signs, oral cavity assessments, nerve injury, and analgesics for intraoral pain. Secondary objectives in subjects 4 and 5 years of age include the safety and tolerability of OraVerse as measured by pain assessments using W-B PRS and evaluation of efficacy assessed by a pediatric Functional Assessment Battery (pFAB) and standardized lip and tongue palpation procedure.
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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 2 to 5 years of age
- •Sufficiently healthy as determined by the Investigator to receive routine dental care
- •Requires a restorative procedure (restoration/filling) in a single quadrant of the mouth
- •Requires local anesthesia with lidocaine 2% with 1:100,000 epinephrine administered by submucosal injection
- •For subjects undergoing mandibular procedures, require an inferior alveolar nerve block for the restorative procedure
- •Dental procedure(s) completed within 60 minutes of injection of local anesthetic
- •For subjects 4 and 5 years of age, can be trained in standardized lip/tongue palpation procedure and pFAB
- •Subjects who are trainable in pFAB and standardized lip/tongue palpation procedure have either:
- •normal pFAB at baseline prior to administration of local anesthetic and
- •at least one abnormal function (smiling, speaking, drinking or drooling) at the completion of the dental procedure OR
- •normal lip sensation at baseline prior to administration of local anesthetic and
- •numbness of the relevant lip quadrant at completion of the dental procedure
- •Subjects give written or verbal assent, as capable and appropriate, and parent(s) or legal guardian(s) give written informed consent
排除标准
- •Weight less than 10 kg
- •Weight less than 15 kg if 4 or 5 years of age
- •History or presence of any condition that contraindicates routine dental care or use of local anesthetic
- •Requires more than ¼ cartridge of local anesthetic if weight is ≥ 10 kg and < 15 kg, more than ½ cartridge of local anesthetic if weight is ≥ 15 kg and < 30 kg, and more than 1 cartridge of local anesthetic if weight is ≥ 30 kg, excluding supplemental injections
- •Allergy or intolerance to lidocaine, epinephrine, sulfites, phentolamine, nitrous oxide or topical benzocaine
- •Has used any investigational drug and/or participated in any clinical study within 30 days of study drug administration
- •Has participated in this study or any previous study of phentolamine mesylate for reversal of local soft tissue anesthesia (STA)
- •Any use of commercial OraVerse™ within 30 days of study drug administration
- •Use of opioid or opioid-like analgesics within 24 hours prior to administration of local anesthetic
- •Requires the use of local anesthetic other than lidocaine 2% with 1:100,000 epinephrine to perform the scheduled dental procedure
- •Requires the use of general anesthesia or sedatives except for nitrous oxide to perform the scheduled dental procedure
- •Any condition which in the opinion of the Investigator increases the risk to the subject of participating in this study or decreases the likelihood of compliance with the protocol
研究组 & 干预措施
OraVerse
OraVerse in doses of either 1/4, 1/2 or 1 cartridge (1.8mL)
干预措施: OraVerse (Drug)
Sham injection
Dentist simulates injection with dental syringe
干预措施: Sham injection (Other)
结局指标
主要结局
Nerve injury
时间窗: Up to 3 days
Incidence and severity of adverse events
时间窗: Up to 3 days
Clinically significant changes in oral cavity assessments
时间窗: Up to 3 days
Analgesics required for intraoral pain
时间窗: Up to 3 days
Clinically significant changes in vital signs
时间窗: Up to 3 days
Blood pressure and pulse
次要结局
- Time to normal tongue sensation(Up to 3 days)
- Time to normal function(Up to 3 days)
- incidence, severity and duration of intraoral pain as measured by W-B PRS(Up to 3 days)
- Time to normal lip sensation(Up to 3 days)