Back to resultsMotion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Primary Purpose
Motion Sickness
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tradipitant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Motion Sickness
Eligibility Criteria
Inclusion Criteria:
- Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);
- Body Mass Index (BMI) of ≥18 and ≤30 kg/m2;
- History or symptoms consistent with motion sickness
Exclusion Criteria:
- Chronic nausea due to condition other than motion sickness;
- A positive test for drugs of abuse at the screening or evaluation visits;
- Clinically significant deviation from normal clinical laboratory results
Sites / Locations
- Vanda Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tradipitant
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Reduction in the incidence of vomiting
As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement
Improvement in the cardinal symptoms of motion sickness
As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03772340
Brief Title
Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Official Title
Motion Sifnos: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
June 6, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motion Sickness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tradipitant
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tradipitant
Intervention Description
Oral capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral capsule
Primary Outcome Measure Information:
Title
Reduction in the incidence of vomiting
Description
As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement
Time Frame
1 Day
Title
Improvement in the cardinal symptoms of motion sickness
Description
As measured by the Motion Sickness Severity Scale Motion Sickness Severity Scale (NRS 0-6); Lower score indicates improvement
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);
Body Mass Index (BMI) of ≥18 and ≤30 kg/m2;
History or symptoms consistent with motion sickness
Exclusion Criteria:
Chronic nausea due to condition other than motion sickness;
A positive test for drugs of abuse at the screening or evaluation visits;
Clinically significant deviation from normal clinical laboratory results
Facility Information:
Facility Name
Vanda Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness
We'll reach out to this number within 24 hrs