stop_circleTerminated/Withdrawn

Rhinitis, Allergic

Exploratory study for allergy relief onset

Trial purpose

The purpose of the study is to explore the onset of effect of an antihistamine in a controlled environment.

Key Participants Requirements

Sex

Both

Age

18 - 65 Years

Trial summary

Enrollment Goal
1
Trial Dates
May 2016 - July 2016
Phase
Phase 2
Could I Receive a placebo
Yes
Products
chlorpheniramine maleate (BAYX002134)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Germantown, 38138, United States

Primary Outcome

  • The time to the meaningful relief, as defined by at least 15% of reduction from baseline in Total Symptom Score (TSS)
    date_rangeTime Frame:
    4 hours
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Number of patients with adverse events as a measure of safety
    date_rangeTime Frame:
    3 month
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A Single-blind, Randomized, Placebo Controlled, Crossover Pilot Study to Evaluate the Onset of Action of an Antihistamine in Subjects Following Allergen Exposure in an Allergen Chamber
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Single Blind
Assignment
Crossover Assignment
Trial Arms
2