EUCTR2014-004919-36-Outside-EU/EEA进行中（未招募）不适用
PLACEBO-CONTROLLED STUDY OF MOMETASONE FUROATE NASAL SPRAY (MFNS) 200 MCG QD IN THE RELIEF OF NASAL CONGESTION ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS (SAR) - Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis
Schering-Plough Research Institute, a Division of Schering Corporation0 个研究点目标入组 351 人开始时间: 2015年2月24日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 351
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. A subject must have been 12 years of age or older, of either sex, and of any race.
- •2. A subject must have had at least a 2-year history of SAR which exacerbated during the study season.
- •3. A subject must have had a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
- •4. A subject must have been clinically symptomatic at the Screening Visit. The following reflective (PRIOR) scores, as assessed by the subject, must have been attained: nasal congestion score =2 and TNSS =6. In addition, the overall evaluation of SAR, as assessed by the subject, must have been =2.
- •5. A subject must have been clinically symptomatic at the Baseline Visit. The total of the seven run-in diary reflective (PRIOR) scores for the 3 days prior to Baseline and the AM of the Baseline Visit must have been: nasal congestion score =14 and TNSS =42.
- •6. A subject must have been in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ECG) results. All laboratory tests must have been within normal limits or clinically acceptable to the investigator and sponsor.
- •7. A subject must have been free of any clinically significant disease, other than seasonal allergic rhinitis, which could have interfered with the study evaluations.
- •8. A subject and/or parent/guardian must have been willing to give written informed consent and must have been able to adhere to dosing and visit schedules and meet study requirements.
- •9. In a female subject of childbearing potential, the serum pregnancy test (human chorionic gonadotropin [hCG]) must have been negative at Screening. Nonsterile and premenopausal female subjects must have been using a medically acceptable method of birth control, ie, double-barrier method, or systemic contraceptive prior to Screening and during the study.
- •10. A female subject of child-bearing potential who was not sexually active must have agreed to use a medically accepted method of contraception if she became sexually active while participating in the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 318
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •1. A subject whose ability to provide informed consent was compromised.
- •2. A subject with a history of noncompliance with medications or treatment protocols.
- •3. A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
- •4. A subject who received any prohibited medication more recently than the indicated washout period prior
- •to Screening, or who continued to receive prohibited medication as defined in the protocol.
- •5. A subject with significant medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment.
- •6. A subject who had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who had a viral upper respiratory infection within 7 days prior to the Screening Visit.
- •7. A subject who used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
- •8. A subject who was participating in any other clinical study.
- •9. A subject who was part of the staff personnel directly involved with this study.
- •10. A subject who was a family member (parent, spouse, or sibling) of the investigational study staff.
- •11. A female subject who was breast-feeding, pregnant, or intended to become pregnant.
- •12. A subject previously randomized into this study.
- •13. A subject who had a family member (parent, spouse, or sibling) currently enrolled in this study.
研究者
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