EUCTR2017-000186-76-Outside-EU/EEA进行中（未招募）1 期
A Phase III, Multi-Center, Randomized, Parallel-Group, Placebo-Controlled and Double- Blind Trial to Study the Efficacy and Safety of MK-4117 in Japanese Subjects with PerennialAllergic Rhinitis. - A Phase III clinical trial of MK-4117 in Japanese subjects with perennial allergic rhinitis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 606
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
- •At Visit 1/Screening
- •Perennial allergic rhinitis subject (Subject expected to meet the inclusion criteria 7 at Visit 2, based on nasal symptoms).
- •Subject either male or female who is 12 years and older when informed consent is given.
- •Out-patient
- •Subject who can make entries in the Subjects Allergy Diary or has a legal representative who can make entries.
- •Subject is a male, or a female that is unlikely to conceive as indicated by a response of yes to any one or more of the following questions: (1) Subject undergone a surgically sterilized female (hysterectomy, ligation of both fallopian tubes, or oophorectomy of both sides) (2) Subject reached natural menopause (defined as =12 months of spontaneous amenorrhea in woman =46 years of age) (3) Subject of reproductive potential and agrees to (a) remain abstinent or (b) use (or have her partner use) 2 acceptable method of birth control within the projected duration of the study (from giving written informed consent) and for 14 days after the last dose of study medication.
- •Subject who could understand the study objective and procedure, and has the ability to give informed assent/consent (informed assent and informed consent must also be obtained from a minor subject and legal representative, respectively, in the case of minors) before the study by subject’s own voluntary.
- •At Visit 2/Week 0/ Randomization
- •Investigator assessed that subject’s symptoms which meet both 2 criteria below during 7 days just before Visit 2. (1) Subject having symptoms of PAR of moderate to severe degree, according to the classification of severity in the Nasal Allergy Treatment Guideline - perennial rhinitis and pollinosis - 2013 (the revised 7th edition)” in Japan [2] (partial revision) (2) Subject having symptoms of PAR as a total score of at least 4 for nasal symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching).
- •Subjects confirmed to be perennial allergic background for mite and/or house dust antigen based on the allergic tests as indicated in the protocol.
- •Subjects whose drug incompliance during the screening period (up to 10 days) is less than 2 days.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 93
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 508
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •At Visit 1/Screening
- •Subject with lower respiratory tract infection and subject who has a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) judged by the investigator to require treatment.
- •Subject with coexisting infections or systemic mycosis for which there are no effective antibiotics.
- •Subject who has asthma complication under treatment.
- •Subject who has nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed.
- •Subject with complication of vasomotor rhinitis or eosinophilic rhinitis.
- •Subject with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
- •Subject with a history of hypersensitivity to antihistamines or ingredients of study drug.
- •Subject who cannot conduct the wash-off the drugs shown in the protocol from the Visit 1, or cannot avoid the use of these drugs during the study period.
- •Subject who had the following treatment within 7 days or 21 days before Visit 1. 1) Within 7 days before Visit 1: a. Corticosteroids (oral, nasal drops [including nasal inhaler], injectable, suppository) b.Immunological drugs 2) Within 21 days before Visit 1. a.Corticosteroids (depot drugs [injectable])
- •Subject who cannot avoid the use of prohibited drugs or therapiesduring the study period.
- •Subject who is currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months.
- •Subject who has the negative results both in skin test and the specific IgE test to house dust and mite antigens.
- •Subject who has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent.
- •Subject with severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor (symptom/disease assessed as grade 3 by severity grading of adverse drug reaction, MHLW Yaku-hatsu No. 80, 29 June 1992).
- •Subject has a history of malignancy or clinically important hematological disorder.
- •Subject has a history of severe drug allergy (e.g., anaphylactoid reaction).
- •Pregnant or lactating woman or woman who may be pregnant.
- •Subject has one or more of the following laboratory abnormalities. (1) AST and/or ALT >2 fold above the ULN (2) Serum creatinine >1.5 mg/dL in male and >1.3 mg/dL in female. (3) Positive urine pregnancy test in females who may be potential to be pregnant.
- •Subject is mentally or legally incompetent to give written assent/consent to participate in the study.
- •Subject is judged inappropriate for study by the investigator or sub-investigator.
- •Visit 2/ Week 0/ at randomization
- •Before 7 days of randomization, subject with coexisting diseases which may affect nasal symptoms, e.g., acute upper respiratory tract infection, acute pharyngolaryngitis and acute tonsillitis.
- •Subject allergic to pollen (cedar, Japanese cypress, birch, gramineae, mugwort, common ragweed, etc.) in the specific IgE test or skin test for whom the pollen season coincides with the study period (at any time from 7 days prior to the randomization to the end of treatment).
- •Positive urine pregnancy test in female who may be potential to be pregnant.
- •Subject is j
研究者
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