NCT02155309

Brief Summary

Part 1, the pharmacokinetic (PK) phase, will expand upon the pilot study conducted at Naval Medical Research Laboratory (NAMRL) and has the goal of determining bioavailability and time to Cmax in a larger representative sample. Part 2, the efficacy phase, is to determine the efficacy of the aqueous spray solution via exposure to a nausea-inducing stimulus.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 17, 2018

Completed
Last Updated

January 17, 2018

Status Verified

December 1, 2017

Enrollment Period

1.8 years

First QC Date

June 2, 2014

Results QC Date

November 6, 2017

Last Update Submit

December 15, 2017

Conditions

Motion Sickness

Keywords

scopolaminemotionsickness

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Number of Head Movements During Rotation

    During rotation, efficacy is measured by the number of head movements subjects are able to make (12 per minute). While seated yaw-axis rotating, a pre-recorded computerized voice informed subjects to make paced head tilts of 30 ̊ to the right and left at a rate of 0.125 Hz (right, center, left, and back to center over 16 seconds).

    40 min

Study Arms (2)

Scopolamine

EXPERIMENTAL

0.2 mg intranasal scopolamine, single dose

Drug: Scopolamine

Placebo

PLACEBO COMPARATOR

placebo intranasal (0.1 mg per nostril), single dose

Drug: Placebo

Interventions

ScopolamineDRUG
Scopolamine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females, 18 to 59 years old, inclusive, in good general health as determined by physical examination and without clinically significant laboratory profiles
  • Normal weight for body size, based on Physical Readiness Test Body Composition Assessment (PPRTBCA) table
  • Willing and able to comply with study requirements and restrictions; and read and sign the informed consent.

You may not qualify if:

  • Known and/or documented drug allergies, especially to scopolamine
  • Use of an investigational drug within 30 days of starting the study
  • Smoking or use of tobacco products, including "chew" or "snuff", within six months
  • Blood donation or significant blood loss within 30 days of starting the study
  • Significant gastrointestinal disorder, asthma, or seizure disorders
  • History of narrow-angle glaucoma
  • History of urinary retention problems
  • History of alcohol or other drug abuse
  • Pregnancy or suspected pregnancy, or lactation
  • Hematocrit values less than 41% for males and 37% for females
  • Recent nasal, nasal sinus or nasal mucosa surgery
  • Use of prescription, over-the-counter, or herbal medication in past 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Naval Medical Research Unit

Dayton, Ohio, 45433, United States

Location

Related Publications (1)

  • Klocker N, Hanschke W, Toussaint S, Verse T. Scopolamine nasal spray in motion sickness: a randomised, controlled, and crossover study for the comparison of two scopolamine nasal sprays with oral dimenhydrinate and placebo. Eur J Pharm Sci. 2001 May;13(2):227-32. doi: 10.1016/s0928-0987(01)00107-5.

    PMID: 11297908BACKGROUND

MeSH Terms

Conditions

Motion Sickness

Interventions

Scopolamine

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Results Point of Contact

Title
Daniel Geyer, MPH
Organization
Henry Jackson Military Foundation for Naval Medical Research Unit - Dayton
daniel.geyer.1.ctr@us.af.mil
(937) 938-3922

Study Officials

  • Willliam J Becker, Phd

    Naval Medical Research Unit - Dayton

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2014

First Posted

June 4, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

January 17, 2018

Results First Posted

January 17, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)