E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The 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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the effectiveness of Sinutab on the symptom relief of nasal congestion and headache in the setting of a common cold. |
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E.2.2 | Secondary objectives of the trial |
1. To assess the effectiveness of Sinutab on the major symptom complex (MSC) of common cold which consists of 4 signs/symptoms: nasal congestion, headache, sore throat, and pressure around the eyes 2. To assess the effectiveness of Sinutab on the symptom relief of individual sign/symptoms, including nasal congestion, headache, sore throat, and pressure around the eyes 3. To assess the number of days lost at work or school 4. To assess the effect of Sinutab on the quality of life (day/night) 5. To assess time-to-resolution of common cold 6. Overall safety evaluation
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
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
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E.4 | Principal exclusion criteria |
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: Analgesics Antipyretics Cough medicines Antihistaminics Corticosteroids Metformine 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, β-blockers, calcium antagonists, angiotensine conversion enzyme inhibitors, angiotensine-II-receptor antagonists, vasodilatation drugs, α-blockers or centrally acting antihypertensives. History of nasal reconstructive surgery. 6.3. Any male subjects taking medication for treatment of Benign Prostate Hypertrophy (BPH): α1-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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in the sum of nasal congestion and headache sign/symptom scores during the treatment period. The nasal congestion and headache scores will be summed by day; the daily sums will be averaged over the treatment days; and the change from the baseline will be calculated. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of Trial in all Participating Pharmacies is defined when data from 300 evaluable subjects are collected and verified.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |