NCT01413958已完成3 期
A Randomized, Placebo-Controlled Trial to Evaluate the Effects of Phenylephrine HCl 30 mg Extended-Release Tablets on Nasal Congestion in Subjects With Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 575
- 主要终点
- Mean Change From Baseline in Daily Reflective Nasal Congestion Score
研究概览
简要总结
This study will compare the nasal congestion symptom relief of phenylephrine extended release tablets and placebo in participants with allergic rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understands study procedures and agrees to participate by giving signed consent form
- •Male or female, aged 18 years or older, at the Screening Visit.
- •Female participants must demonstrate a negative urine pregnancy test, at Screening (Visit 1) and Visit 2 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control are abstinence, or two of the following:
- •hormonal contraceptives (with documented use for at least 30 days prior to Screening )
- •intrauterine device (IUD)
- •diaphragm with spermicide
- •contraceptive sponge
- •vasectomy
- •Willing to stop use of current decongestant and allergy medications during the trial
- •Documented or self-reported history of allergic rhinitis caused by fall pollen within the last 4 years
- •and documented or self-reported symptoms over at least the last 2 fall allergy seasons
- •Documented skin testing (prick with wheal ≥3 mm larger than the diluent or intradermal with wheal ≥7 mm larger than the diluent control) within the last 4 years to fall pollen allergens present and prevalent in his/her geographic region.
- •Signs and symptoms of nasal congestion (defined as stuffy or blocked nose) of at least mild severity (sign/symptom clearly present, but minimal awareness; easily tolerated) following the washout period (if applicable). Participant's diary evaluation must document at least mild symptoms for reflective and instantaneous scores on 4 consecutive days prior to randomization.
- •Mean seated (after 5 minutes of rest) systolic/diastolic blood pressure ≤ 138/88 mmHg.
- •Clinically acceptable physical exam and 12-lead ECG (recorded at 25 mm/s) that is clinically acceptable to the investigator.
- •Free of any clinically significant disease that requires a physician's care and/or would interfere with trial evaluations, procedures, or participation.
- •Agrees not to take monoamine oxidase inhibitors (MAOIs) from 14 days before trial participation until 14 days after the last dose of study drug.
- •Capable of reading English.
排除标准
- •Significant medical condition that is a contraindication to the use of phenylephrine, might
- •interfere with the trial, or requires treatment expected to affect blood pressure
- •History or presence of hypertension
- •Started allergen immunotherapy within 1 month of enrollment, will start immunotherapy during
- •the trial, or anticipates immunotherapy dose change during the trial
- •Used Xolair (omalizumab) within 4 years prior to trial participation
- •Known allergy or intolerance to phenylephrine, loratadine, or desloratadine
- •History of rhinitis medicamentosa
- •Documented evidence of acute or significant chronic sinusitis
- •Clinically significant nasal disorders such as deviated septum and nasal polyposis
- •Asthma, with the exception of mild intermittent asthma
- •Have used systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone
- •permitted), or nasal corticosteroids in the last 30 days
- •Mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit or expected during the conduct of the study, or has a history of a clinically significant psychiatric disorder over the last 5 years. Those who have had situational depression may be enrolled in the study at the discretion of the investigator.
- •History of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the participant by their participation in the study.
- •History of immunological disease or cancer within the past 5 years, with the exception of nonmelanoma skin cancer
- •Positive drug screen (participants on prescribed medication resulting in a positive drug screen result may still be enrolled at the discretion of the investigator).
- •Major surgery or participation in another investigational study within 30 days prior to the Screening Visit.
- •Body mass index (BMI) ≥ 40
研究组 & 干预措施
Phenylephrine
Experimental
干预措施: Phenylephrine (Drug)
Phenylephrine
Experimental
干预措施: Loratadine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Loratadine (Drug)
结局指标
主要结局
Mean Change From Baseline in Daily Reflective Nasal Congestion Score
时间窗: Baseline and Days 1-7
The reflective assessment is a self-evaluation of the symptom severity over the preceding 12 hours. Baseline values were calculated as the mean from 4 consecutive 24-hour periods in which a symptom score was ≥1, prior to randomization. The nasal congestion score was calculated from data captured twice daily (morning and evening) in the participant's diary during the run-in and treatment periods. Participants rated congestion on a 4-point scale of severity: 0 = absent symptoms (no sign/symptom evident), 1 = mild symptoms (sign/symptom clearly present, but minimal awareness; easily tolerated), 2 = moderate symptoms (definite awareness of sign/symptom that is bothersome but tolerable), and 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The average of individual reflective nasal scores was reported as the daily reflective nasal congestion score over the entire treatment period.
次要结局
- Mean Change From Baseline in Daily Reflective Nasal Congestion Score Per Day(Baseline and Day 1, 2, 3, 4, 5, 6, and 7)
- Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score Per Day(Baseline and Day 1, 2, 3, 4, 5, 6, 7)
- Mean Change From Baseline in Morning Predose Instantaneous Nasal Congestion Symptom Score(Baseline and Days 1-7)
- Mean Change From Baseline in the Morning Reflective Symptom Assessment Score(Baseline and Days 1-7)
- Mean Change From Baseline in the Evening Reflective Symptom Assessment Score(Baseline and Days 1-7)
- Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score(Baseline and Days 1-7)
- Time to Maximal Phenylephrine Effect(Baseline up to Day 7)
- Day 7 Mean Change From Baseline in Daily Instantaneous Symptom Assessment Score(Baseline and Day 7)
- Mean Change From Baseline for the Morning Reflective Symptom Assessment Scores for Each Day During the Treatment Period.(Baseline and Day 2, 3, 4, 5, 6, and 7)
- Mean Change From Baseline for the Evening Reflective Symptom Assessment Scores for Each Day During the Treatment Period(Baseline and Day 1, 2, 3, 4, 5, 6, and 7)
- Mean Change From Baseline for the Morning Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period(Baseline and Day 2, 3, 4, 5, 6, and 7)
- Mean Change From Baseline for the Evening Instantaneous Symptom Assessment Scores for Each Day During the Treatment Period.(Baseline and Day 1, 2, 3, 4, 5, 6, and 7)
- Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities (RQLQ)(Up to Day 8)
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