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TerminatedNCT02722083Updated Dec 12, 2018

Exploratory Study for Allergy Relief Onset

A Phase 2 interventional study of Chlorpheniramine maleate (BAY X002134) and Placebo in Rhinitis, Allergic, sponsored by Bayer. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-12-12.

Sponsored by Bayer · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Rhinitis, Allergic
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 1 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    BAY X002134

    Subjects will be given BAY X002134

    Drug: Chlorpheniramine maleate (BAY X002134)

  • Placebo comparator
    Placebo

    Subjects will be given a placebo

    Drug: Placebo

Interventions

  • DrugChlorpheniramine maleate (BAY X002134)

    4 mg tablet, single dose, orally

  • DrugPlacebo

    placebo tablet, single dose, orally

06

What researchers measure

Primary outcomes

  1. The time to the meaningful relief, as defined by at least 15% of reduction from baseline in Total Symptom Score (TSS)

    Time frame: 4 hours

Secondary outcomes

  1. Number of patients with adverse events as a measure of safety

    Time frame: 3 month

07

Study locations

1 site
  • Germantown, Tennessee 38138, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02722083
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Mar 29, 2016
Start date
May 7, 2016
Primary completion
May 27, 2016
Completion
Jul 13, 2016
Last update
Dec 12, 2018

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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