A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of the Safety, Efficacy and Pharmacokinetics of DPI-386 Nasal Gel for the Prevention and Treatment of Nausea Associated With Motion Sickness
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Adverse Event (AE) Reporting of DPI-386
研究概览
简要总结
Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to identify the safety, efficacy and pharmacokinetics of a repeated-dose regimen of DPI 386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of nausea associated with motion sickness.
详细描述
This Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study to identify the safety, efficacy and pharmacokinetics of a repeated-dose regimen of DPI 386 nasal gel (intranasal scopolamine gel) for the prevention and treatment of nausea associated with motion sickness. The study will have three arms: DPI-386 nasal gel, placebo nasal gel, and TDS patch (1.5 mg/72 hours), the current standard of care for the treatment of motion sickness. The study will include 34 subjects per arm, for a total of 102 subjects (n=102). A double dummy design will be used to mask the treatment assignment. All subjects will receive both a patch and nasal gel randomized to one of the following three arms: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch.
Treatment Day 1 will be conducted aboard an ocean-going vessel to obtain data in an operationally relevant real world environment immediately followed by Treatment Days 2 and 3 at a clinical site or one of its two satellite locations.
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)
盲法说明
study is double-blinded placebo controlled for all treatment arms. All DPI-386 Nasal Gel and placebo nasal gel vials are opaque and indistinguishable. The DPI-386 Nasal Gel and placebo nasal gels are identical in color and viscosity, and without identifiable smell. Each placebo patch is similar in color and size as the TDS patch but does not deliver any medication or contain any excipients. A designated independent (unblinded) applicator will administer all patch application and removal, including an opaque waterproof bandage cover over the patch, to further prevent unblinding.
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 a signed and dated Informed Consent Form (ICF).
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged 18 to 59 (inclusive).
- •At least two responses on the MSSQ must be "Sometimes" or "Frequently".
- •In good general health as evidenced by medical history with no recent history or current diagnosis of uncontrolled clinical problems as assessed by the Principal Investigator (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. The test must be negative within seven days of the Treatment Day
- •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 three Treatment Days.
- •Abstain from alcohol for 24 hours prior to first dose of study medication and during the three Treatment Days.
排除标准
- •Pregnancy, lactation, or positive urine pregnancy test within seven days of Treatment Day
- •Known allergic reactions to scopolamine or other anticholinergics.
- •Currently prescribed any of the following medication types and used within the specified washout periods below:
- •any form of scopolamine (including Transderm Scop®) (washout 5 days)
- •belladonna alkaloids (washout 2 weeks),
- •antihistamines (including meclizine) (washout 2 weeks),
- •tricyclic antidepressants (washout 2 weeks),
- •muscle relaxants (washout 4 days) and
- •nasal decongestants (washout 4 days)
- •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 if any of the following medical conditions were experienced more than two years ago and are deemed clinically significant by the PI or qualified designee:
- •Significant gastrointestinal disorder, asthma, or seizure disorders.
- •History of cardiovascular disease.
- •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 + placebo patch
DPI-386 Nasal Gel: Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr
干预措施: DPI-386 Nasal Gel (Drug)
DPI-386 Nasal Gel + placebo patch
DPI-386 Nasal Gel: Each 0.12 gram of the gel contains 0.2 mg of scopolamine HBr
干预措施: Placebos (Drug)
Placebo nasal gel + Placebo patch
Placebo
干预措施: Placebos (Drug)
placebo nasal gel + TDS patch
Transderm Scop® is a commercial transdermal scopolamine (TDS) patch worn behind the ear containing a 1.5 mg reservoir of scopolamine to be delivered over a 72-hour period.
干预措施: DPI-386 Nasal Gel (Drug)
placebo nasal gel + TDS patch
Transderm Scop® is a commercial transdermal scopolamine (TDS) patch worn behind the ear containing a 1.5 mg reservoir of scopolamine to be delivered over a 72-hour period.
干预措施: Placebos (Drug)
结局指标
主要结局
Adverse Event (AE) Reporting of DPI-386
时间窗: 7 weeks
Number of subjects with indicated AEs receiving DPI-386
Incidence of subjects who developed motion sickness.
时间窗: 8 hours
Number of Subjects who developed motion sickness
次要结局
- Severity of nausea as measured by the Visual Analog Scale (VAS)(During the 8 hour voyage on Treatment Day 1.)
- Severity of motion sickness as measured by the Motion Sickness Assessment Questionnaire (MSAQ) over the treatment period.(During the 8 hour voyage on Treatment Day 1.)
- 3. Cognition as measured by the Automated Neuropsychological Assessment Metrics (ANAM).(During all three Treatment Days.)
- Pharmacokinetic parameters of DPI-386 to be measured will include Maximum Observed Plasma Concentrations (Cmax)(On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.)
- Pharmacokinetic parameters of DPI-386 to be measured will include Time to Reach Maximum Observed Plasma Concentration (tmax).(On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.)
- Pharmacokinetic parameters of DPI-386 to be measured will include Area Under the Curve (AUC).(On Treatment Days 2 -3, PK draws will occur at the following time points: -60, 30, 60, 90, 120, 180, 330, 390, 450, 480 and 600 minutes.)