stop_circleTerminated/Withdrawn

Rhinitis, Allergic

Bayer Identifier:

18573

ClinicalTrials.gov Identifier:

NCT02722083

EudraCT Number:

Not Available

EU CT Number:

Not Available
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
  • - Ambulatory healthy male and female subjects between 18 to 65 years of age inclusive;  
    - Self-reported to have seasonal allergic rhinitis for at least 2 years prior 
    - Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen; prick with wheal > 4mm larger than the diluent within the previous 12 months  
    - Total Symptom Score (TSS) ≥ 40 mm at the 90 or 120 minute time point during one of the Priming Visits and at 90 or 120 minute time points during ragweed challenge Symptom Induction Phase of each Treatment Visit;  
    - Body Mass Index (BMI) in the range of 18 to 30 kg/m2
    - Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, injectable contraceptive (e.g. Depo-Provera®), or a double barrier and have a negative pregnancy test at Screening and prior to IMP administration on Day 1 and Day 7 ± 1 day. Female subjects of non-childbearing potential must be amenorrheic for at least two years or had a hysterectomy and/or bilateral oophorectomy

  • - Evidence or self-reported history of significant medical condition which, in the judgment of the investigator, is a contraindication to the use of chlorpheniramine, or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease , symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, narrow-angle glaucoma, pyloroduodenal obstruction, or stenosing peptic ulcer;
    - Known allergy to chlorpheniramine, dexchlorpheniramine, or any of its inactive ingredients
    - Self-reported non-responders (lack of therapeutic effect) to antihistamines
    - Administration of epinephrine is contra-indicated;
    - Current use of oral steroids, including prednisone and prednisolone;  
    - Females who are pregnant or lactating  
    - A history of anaphylaxis to ragweed allergen
    - Subjects with a history of asthma, lower respiratory tract disease, emphysema or chronic bronchitis; At the discretion of the investigator, subjects with self-reported mild intermittent asthma or exercise induced asthma may be included.

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.