Motion Sifnos: A Study to Investigate the Efficacy of Tradipitant in Subjects Affected by Motion Sickness

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2019-06-27

Brief Summary

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Randomized, double-blind, placebo-controlled investigating the efficacy of tradipitant in the treatment of motion sickness.

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Detailed Description

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Conditions

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Motion Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tradipitant

Group Type EXPERIMENTAL

Tradipitant

Intervention Type DRUG

Oral capsule

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral capsule

Interventions

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Tradipitant

Oral capsule

Intervention Type DRUG

Placebo

Oral capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or non-pregnant, non-lactating female patients aged 18 - 75 years (inclusive);
* Body Mass Index (BMI) of ≥18 and \<40 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No