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Exploratory Study for Allergy Relief Onset

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02722083
Recruitment Status : Terminated
First Posted : March 29, 2016
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic Drug: Chlorpheniramine maleate (BAY X002134) Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 7, 2016
Actual Primary Completion Date : May 27, 2016
Actual Study Completion Date : July 13, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BAY X002134
Subjects will be given BAY X002134
Drug: Chlorpheniramine maleate (BAY X002134)
4 mg tablet, single dose, orally

Placebo Comparator: Placebo
Subjects will be given a placebo
Drug: Placebo
placebo tablet, single dose, orally




Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of patients with adverse events as a measure of safety [ Time Frame: 3 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722083


Locations
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United States, Tennessee
Germantown, Tennessee, United States, 38138
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02722083     History of Changes
Other Study ID Numbers: 18573
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Chlorpheniramine
Antipruritics
Dermatologic Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents