EUCTR2006-000058-35-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) and Pseudoephedrine (30mg)] on subjects with nasal congestion accompanied by headache in the setting of a common cold
Pfizer Consumer Healthcare Comm. VA/SCA0 个研究点开始时间: 2006年4月14日最近更新:
适应症
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
- •Only subjects asking for Sinutab® in the pharmacy can participate in the study. These subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •1. Age 18 years or more
- •2. Reported cold symptoms begin = 48 hours prior to visit 1
- •3. Scored > or = 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. Patients without an electronic medication record in the pharmacy
- •2. Have a history of hypersensitivity to paracetamol or pseudoephedrine or lactose
- •3. Have a fever more than 38.0°C (measured by pharmacist)
- •4. Women in the fertile years who do not practise a hormonal contraception or an intra-uterine device
- •5. Use of concomitant drugs that could interfere with the study drug; See concomitant medication Questionnaire.
- •Not allowed is current use (nasal, oral or inhalation) of:
- •Antipyretics
- •Cough medicines
- •Antihistaminics
- •Corticosteroids
- •Sympathomimetics and
- •Anticholinergic drugs
- •Not allowed is current or past (= 2 weeks) use of:
- •Monoamine oxidase inhibitors
- •Antibiotics
- •6. Any important intercurrent medical condition will be excluded based on the available medication record of the patient. (cf. exclusion criterium 1)
- •6.1. Bronchial asthma and Chronic Obstructive Pulmonary Disease (COPD) will be excluded by the use of sympathomimetics, anticholinergics, theofylline and derivatives, inhalation steroids, inhibitors of mediator release, leukotriene receptor antagonists, Dopram®, Alvofact® or Survanta®; Allergies will be excluded by the use of treatment for desensitization to household or seasonal allergies, such as Pollinex® or individually tailored preparations. Excepted are: (1) non-active seasonal allergies, (2) drug allergies other than paracetamol and pseudoephedrine (cf. 1), and (3) food allergies.
- •6.2. Subjects using antihypertensive treatment: diuretics, ß-blockers, calcium antagonists, angiotensine conversion enzyme inhibitors, angiotensine-II-receptor antagonists, vasodilatation drugs, a-blockers or centrally acting antihypertensives. History of nasal reconstructive surgery.
- •6.3. Any male subjects taking medication for treatment of Benign Prostate Hypertrophy (BPH): a1-blockers, 5-alpha-reductase-inhibitors or phytotherapy based on Serenoa repens.
- •6.4. A history of alcohol and/or drug abuse within a 6-month period immediately preceding the screening visit.
- •6.5. Use of medication for treatment of cardiovascular conditions other than hypertension: drugs for treatment of heart failure, antianginal drugs, antiarrhythmics or Omacor®.
- •6.6. Use of medication for treatment of cholelithiasis (urodesoxychol acid), and drugs used for a whole spectrum of symptoms in the hepatobiliary scope, including Cantabiline®, Hebucol®, Vibtil® and relatives.
- •6.7. Use of antitumour agents.
- •6.8. Use of tuberculostatics or antiviral medicines (e.g. HIV).
- •6.9. The use of tricyclic antidepressants (TCA’s), Trazodone® or antipsychotics: fenothiazine, thioxanthene, butyrofenone, difenylpiperidine, benzamine or atypical neuroleptics.
- •Any such medication or indication that might point to an increased 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.
- •7. Participation in other clinical trials the last three months and during study participation.
- •8. Employees of the clinical research centers Pfizer, the CRO’s contracted for this study, or their immediate family members are not permitted to participate in this study.
研究者
相似试验
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 coldMedical rationale= Investigation of combination drug Sinutab in symptomatic relief of common cold with nasal symptoms. Community pharmacists are considered as local investigators including subjects with early (= 48 hours) cold symptoms of blocked nose with headache and/or fever.EUCTR2004-001637-41-BEPfizer Consumer Healthcare cva/sca
尚未招募
不适用
Evaluating the feasibility and acceptability of the MedsCheck Plus service amongst community pharmacists and home-dwelling people living with dementiaDementiaACTRN12622001172796niversity of New South Wales (UNSW)25
尚未招募
不适用
Improving the management of sleep disorders in the communitySleep disordersSleep-related symptomsPublic Health - Health service researchACTRN12612000825853Zaswiza Mohamad Noor110
尚未招募
Unknown
Evaluation of efficacy of the community pharmacy intervention to optimize serum potassium levels in patients with chronic kidney diseasechronic kidney diseaseJPRN-UMIN000049814ational Hospital Organization Mie Chuo Medical Center40
招募中
不适用
Increasing Community Pharmacy Involvement in the Prevention of Cardiovascular Disease ProjectACTRN12609000705280Monash450