A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic Rhinitis
A Non-controlled, Open Study for Assessing the Safety and Effectiveness of a Twice-daily FEX 60 mg - PE 10 mg (FEX60/PE10) Fixed Combination Tablet in Patients With Allergic Rhinitis
Primary Objective:
To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet in patients with allergic rhinitis.
Secondary Objective:
To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.
調査の概要
詳細な説明
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Tokyo、日本
- Sanofi Administrative Office
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
- Outpatients with a history of seasonal or perennial allergic rhinitis for at least 1 year confirmed by positive skin prick test to out or indoor allergens (wheal ≥3mm compared to control [diluent]) or positive specific IgE Antibody test (ie, radioallergosorbent test [RAST], etc.) on the day of provisional inclusion in the trial.
Patients who meet the following criteria of symptom score. (The symptom score is rated according to the 'Severity of nasal symptoms'):
- Nasal congestion score is consistently from 2 to 3 but not 4 for the last 3 days of the screening period.
- Score of sneezing or rhinorrhea is consistently 2 or 3 but not 4 throughout the last 3 days of the screening period.
- Patients aged 15 years or older, with no restriction on gender.
- Patients written informed consent.
- Females with childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of study drug and adequate contraception during the study.
Exclusion criteria:
- Patients with nasal diseases (hypertrophic rhinitis, paranasal sinusitis, nasal polyps, acute rhinitis, deviation of the nasal septum, etc.) that could interfere with judgment of the efficacy of the investigational product (IP) and patients developing cold-like symptoms during screening period.
- Patients with severe asthma, bronchiectasis, severe hepatic, renal, or cardiac dysfunction, hematological, endocrine disease, and other serious complications.
- Patients with unstable medical conditions like diabetes mellitus, heart failure, hepatic and renal impairment.
- Patients with a history of epilepsy or with organic brain disease, which may cause epilepsy.
Patients who have taken any of the following medications that may affect the evaluation of the IP, Patients using intranasal or systemic decongestants if they are not stopped 3 days before the inclusion visit.
Within 1 week prior to the day of registration:
Intranasal or oral:
- Antiallergic drugs, antihistamines, anticholinergic agents, vasoconstrictor, antihistamine-containing cold remedies, agents that can be expected to have an antiallergic/antihistaminic effect (including Chinese medicines and glycyrrhizin), and other agents that are indicated for allergic symptoms (sneezing, rhinorrhea, nasal congestion, etc.).
- Agents that may affect the blood concentration of Fexofenadine (FEX) (macrolide antibiotics, azole fungicides, and preparations containing aluminum hydroxide/magnesium hydroxide).
Within 2 weeks prior to the day of registration:
o Steroids, immunosuppressant, and nonspecific alternative therapy (histamine-containing gamma-globulin preparations etc).
Within 4 weeks prior to the day of registration:
- Patients receiving oral, nasal, inhaled corticosteroids.
- Depot steroid preparations.
- Patients using sodium cromoglycate/nedocromil or leukotriene modifiers if they are not stopped 14 days before the inclusion.
- Patients under immunotherapy if specific immunotherapy has been started or dose changed approximately 1 month preceding enrolment in the study, (doses should maintain the same dose throughout the trial).
- Patients suffering from Upper Respiratory Tract Infection, sinusitis or acute otitis media within 30 days before the inclusion visit.
- Patients who are participating in another study or who have previously participated in another study within the previous 6 months prior to the day of registration.
- Patients who are considered by the Investigator/sub-investigator to be unsuitable for enrolment in the study for any other criterion or previously participated in this study.
- Patients with a history of hypersensitivity to antihistamines or antiallergic agents including FEX.
- Patients with severe hypertension or severe coronary artery disease, narrow angle glaucoma, urinary retention, or those who have shown sensitivity to adrenergic agents (manifestations include insomnia dizziness, weakness, tremor, or arrhythmias).
- Patients receiving monoamine oxidase (MAO) inhibitor therapy or within 2 weeks prior to the day of registration.
- Women who are pregnant, possibly pregnant, or breast-feeding.
- Patients with underlying hepatobiliary disease. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:FEX60/PE10
Internal use of FEX60/PE10 combination tablet will be administered twice daily (1 tablet per intake) for 2 weeks
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Pharmaceutical form:tablet Route of administration: oral
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Number of adverse events (Solicited AE reporting)
時間枠:From intake of FEX60/PE10 up to approximately 2 weeks
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From intake of FEX60/PE10 up to approximately 2 weeks
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Changes from baseline in the nasal congestion score based on the patient's symptom diary
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Change from baseline in the total score of 3 nasal symptoms (sneezing, rhinorrhea, and nasal congestion)
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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Change in the total score of 3 nasal symptoms on a daily basis
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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Change in the total score of 3 nasal symptoms during daytime
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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Change in the total score of 3 nasal symptoms during night-time
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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Change in the daily activity impairment score
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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Change in the daily activity impairment score on a daily basis
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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Change in the daily activity impairment score during daytime
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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Change in the daily activity impairment score during night-time
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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Change in nasal findings from baseline: color of inferior turbinate mucosa
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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Change in nasal findings from baseline: congestion of inferior turbinate mucosa
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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Change in nasal findings from baseline: consistency of discharge
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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Assessment of patient's impression after treatment based on patient's symptom diary
時間枠:After 2 weeks treatment
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After 2 weeks treatment
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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