EUCTR2004-001637-41-BE进行中（未招募）不适用
A community pharmacy based investigation in the self-medication areaEfficacy and safety of Sinutab® (Paracetamol (500mg)/Pseudoephedrine (30mg)) on subjects with nasal congestion accompanied by headache and/or fever in the setting of a common cold
Pfizer Consumer Healthcare cva/sca0 个研究点开始时间: 2005年8月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Age 18 years or more
- •2. Reported cold symptoms begin = 48 hours prior to visit 1
- •3. Scored = 2 for each of nasal congestion and headache using the Modified Jackson Subject Evaluation Scale
- •4. Willing and able to comply with scheduled visits, treatment plan, and other study procedures
- •5. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Have a history of hypersensitivity to paracetamol or pseudoephedrine or lactose
- •2. Have a fever more than 38.0°C (measured by pharmacist)
- •3. Pregnancy, lactation or intended pregnancy
- •4. Are unwilling or unable to abstain from the use of antihistamines or cold/cough/pain preparations during the treatment period
- •5. Use of concomitant drugs that could interfere with the study drug; See concomitant medication Questionnaire
- •Drugs not allowed are: Analgesics, Antipyretics, Cough medicines, Antihistaminics,
- •Corticosteroids (inhalation corticosteroids included), Sympathomimetics and
- •Anticholinergic drugs
- •6. Take or have taken monoamine oxidase inhibitors within the past 2 weeks
- •7. Respiratory and/or bacterial sinusitis infection or have used antibiotics during the past 2 weeks
- •8. Any important intercurrent medical condition; The subject has given the answers under Medical History
- •8.1. Bronchial asthma, clinical bronchitis or other significant respiratory diseases such as chronic obstructive pulmonary disease (COPD), emphysema or diseases requiring any use of assisted ventilation or continuous Positive Airway Pressure. Allergies to household allergens (e.g. dust, pets, etc.) and active seasonal allergies, excepted: (1) non-active seasonal allergies, (2) drug allergies, and (3) food allergies.
- •8.2. Have significant nasal abnormalities such as significant nasal mucosa thickening or severe nasal septal deviation, polyps, or other known significant structural abnormalities of the nasal cavity (based on subject medical history)
- •8.3. History of nasal reconstructive surgery
- •8.4. Subjects with known hypertension (active or history)
- •8.5. Any male subjects with a positive history of Benign Prostatic Hypertrophy (BPH) who are symptomatic or who are not currently well-controlled
- •8.6. Have a history of alcohol and/or drug abuse within a 6-month period immediately
- •preceding the screening visit
- •8.7. Have conditions that might interfere with the drug studied e.g. cardiovascular (a gradation will be taken into account), respiratory, neurological, renal, urogenital, hepatic or malignant diseases, malnutrition or any chronic systemic infection (e.g. HIV)
- •9. Other severe acute or chronic medical or psychiatric condition or known laboratory
- •abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the sub-investigator, would make the subject inappropriate for entry into this study
- •10. Participation in other clinical trials the last three months and during study participation
- •11. Employees of the clinical research centers at Pfizer, the CRO’s contracted for this study, or their immediate family members, are not permitted to participate in this study.
研究者
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A community pharmacy based investigation in the self-medication areaEfficacy and safety of Sinutab® [Paracetamol (500mg) and Pseudoephedrine (30mg)] on subjects with nasal congestion accompanied by headache in the setting of a common coldThe medical rationale = to investigate this combination drug in the symptomatic relief of common cold with nasal symptoms. The reduction of symptom severity may allow subjects receiving active medication to return to work or school earlier than those receiving placebo. To study the drug in it’s ‘natural environment’, community pharmacists will function as local investigators. They will include subjects with early (= 48 hours) cold symptoms of blocked nose with headache.EUCTR2006-000058-35-BEPfizer Consumer Healthcare Comm. VA/SCA
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