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

• Conditions: 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.

• Registration Number: EUCTR2006-000058-35-BE
• Lead Sponsor: Pfizer Consumer Healthcare Comm. VA/SCA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-14
• Last Update Posted: 7 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

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, 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified