A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Safety and Efficacy of DPI-386 Nasal Gel Under Military Operational Conditions for the Prevention of Nausea Associated With Motion Sickness
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Efficacy of DPI-386 Nasal Gel
研究概览
简要总结
This multi-site Phase 3 clinical trial is a randomized, double-blind, placebo-controlled and open label active-controlled study to identify the safety and efficacy of a repeated-dose regimen of DPI-386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of motion sickness. The study will be conducted aboard Navy fleet or Marine ships undergoing military operations to obtain data in an operationally relevant real world environment.
详细描述
The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and Transderm Scop® (1.5 mg/72 hours; transdermal scopolamine patch [TDS], the current standard of care for the treatment of motion sickness). The study will include 100 subjects per arm, for a total of 300 subjects (n=300). Multiple ships and ships' crews will be used, until the required enrollment is completed. The DPI-386 Nasal Gel and placebo nasal gel arms will be double-blinded, whereas the TDS arm will remain unblinded. Both DPI-386 Nasal Gel and placebo nasal gel will be administered twice daily over the six consecutive Treatment Days. The two daily doses of DPI-386 Nasal Gel or placebo nasal gel will be separated by a minimum of six hours ± 15 minutes, and will occur during the subject's on-duty period. The TDS patch will be administered on Treatment Days 1 and 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated ICD.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged 18 to 59 (inclusive).
- •Active duty military or reserves on active status. All potential subjects must be able to provide a current military ID to be viewed by PI or qualified designee prior to signing the ICD.
- •At least minimally susceptible to provocative motion as evidenced by a minimum score of 3.0 on the Motion Sickness Susceptibility Questionnaire (MSSQ).
- •In good general health as evidenced by medical history with no recent history or current diagnosis of clinical problems as recommended by the PI or qualified designee.
- •Ability to take intranasal medication and willingness to adhere to the study schedule and time constraints.
- •For females of child-bearing potential: willingness to provide a urine sample for the hCG pregnancy test. Test must be negative.
- •Agreement to adhere to the following lifestyle compliance considerations:
- •Refrain from consumption of grapefruit and any substance containing grapefruit for seven days prior to, during, and for seven days after the six treatment days.
- •Abstain from alcohol for 24 hours prior to first dose of study medication and during the six Treatment Days.
排除标准
- •Pregnancy, lactation, or positive urine pregnancy test at screening.
- •Known allergic reactions to scopolamine or other anticholinergics.
- •Currently prescribed any of the following medication types: belladonna alkaloids, antihistamines (including meclizine), tricyclic antidepressants, and muscle relaxants.
- •Hospitalization or significant surgery requiring hospital admittance within the past six months.
- •Treatment with another investigational drug or other intervention within the past 30 days.
- •Having donated blood or plasma or suffered significant blood loss within the past 30 days.
- •Having any of the following medical conditions within the last two years or deemed clinically significant by the PI or qualified designee as being exclusionary:
- •Significant gastrointestinal disorder, asthma, or seizure disorders.
- •History of vestibular disorders.
- •History of narrow-angle glaucoma.
- •History of urinary retention problems.
- •History of alcohol or drug abuse.
- •Nasal, nasal sinus, or nasal mucosa surgery.
研究组 & 干预措施
DPI-386 nasal gel
DPI-386 Nasal Gel is formulated to contain 0.2 mg scopolamine HBr per 0.1 g dose, with each dose therefore described as "0.2 mg / 0.1 g"
干预措施: scopolamine HBr (Drug)
placebo nasal gel
Placebo nasal gel product is the same but does not contain scopolamine HBr
干预措施: scopolamine HBr (Drug)
Transderm Scop®
TDS patch delivers 1.5 mg of scopolamine over a 72-hour period. TDS arm will apply two TDS patches over the six treatment days.
干预措施: Transdermal Scopolamine (Drug)
结局指标
主要结局
Efficacy of DPI-386 Nasal Gel
时间窗: 3 days
Compare the efficacy of DPI-386 Nasal Gel (0.2 mg scopolamine HBr per dose, maximum of two doses per day, for a maximum of six doses over three consecutive days) with that of the TDS patch and placebo nasal gel in the prevention and treatment of nausea associated with motion sickness. The efficacy endpoint will be determined by comparing the Motion Sickness Assessment Questionnaire (MSAQ) scores over the treatment period across all three treatment arm. Sixteen symptoms are listed, with symptoms differentiated along four dimensions: gastrointestinal, central, peripheral, and sopite-related. Each symptom is scored from 1 to 9 in severity and scores then calculated. All 16 items were collected from the general public instead of experts, allowing for a more accurate wording of the symptomology experienced by persons outside of hysiological sciences.
Safety of DPI-386 Nasal Gel in terms of cognitive effects
时间窗: 24 hours
Compare the safety of DPI-386 Nasal Gel with that of the TDS patch and placebo nasal gel, with an emphasis on cognitive effects by incidence of treatment related adverse events.
次要结局
- Efficacy of DPI-386 and severe nausea(3 days)
- Safety of DPI-386 Nasal Gel in terms of cognition(24 hours)