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Sponsored by: |
Johnson & Johnson Consumer & Personal Products Worldwide |
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Information provided by: | Johnson & Johnson Consumer & Personal Products Worldwide |
ClinicalTrials.gov Identifier: | NCT00378144 |
The purpose of this study is to investigate the efficacy and safety for a marketed sinus allergy product, Sinutab, in the treatment of nasal congestion and headache.
Condition | Intervention | Phase |
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Common Cold Headache Nasal Congestion |
Drug: Pseudoephedrine/Paracetamol |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Community Pharmacy Based Investigation in the Self-Medication Area Efficacy and Safety of Sinutab and Pseudoephedrine on Subjects With Nasal Congestion Accompanied by Headache in the Setting of a Common Cold |
Enrollment: | 469 |
Study Start Date: | January 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Pseudoephedrine/Paracetamol
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Drug: Pseudoephedrine/Paracetamol
Fixed oral tablet doses, 2 tablets 3 times a day for 5 days with at least 4 hours between each treatment (morning-noon-evening) and last dose not later than 2 hours before bedtime [Paracetamol (500 mg) and Pseudoephedrine (30 mg)]
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In response to a mandated requirement from the Belgium Medicines Agency - rising from the perforce switch of Sinutab® to a 2 active ingredients Pseudoephedrine+Paracetamol combination - we have made a commitment to demonstrate the safety and efficacy of Sinutab®.
In agreement with the Medicines Agency, an in-use Pharmacy-based study has been designed to demonstrate efficacy and safety of Sinutab® for the approved indications (symptomatic relief in the common cold).
This will be a randomized, double blind, placebo-controlled, comparative phase 4, multi-centre study in parallel groups between Sinutab and placebo. To study the drug in it's 'natural environment', community pharmacists will function as local investigators. Approximately 25 community pharmacists will be carefully selected, and only be taken into consideration if appropriate software programs are used in their pharmacy.
This implicates that the pharmacist has a medication record of his patients at his disposal which he will use to check the exclusion criteria. They will include subjects with early (≤ 48 hours) cold symptoms of blocked nose with headache. Subjects fulfilling the inclusion/exclusion criteria will be assigned to one of the two treatment groups, according to a computer-generated randomization list. A sufficient number of subjects will be randomized in the order of their enrolment, targeting at 300 evaluable subjects at the conclusion of study.
The following information will be collected every evening from subjects during 7 days: symptom assessment, compliance, adverse events and the ability to go to work or school.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium, Antwerp | |
JJCPPW Investigational Site | |
Wilrijk, Antwerp, Belgium |
Study Director: | Elisabeth A Kruse, PhD | JJCPPW |
Responsible Party: | JJCPPW ( Joyce Hauze/Senior Project Manager ) |
Study ID Numbers: | A7801002 |
Study First Received: | September 5, 2006 |
Last Updated: | January 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00378144 History of Changes |
Health Authority: | Belgium: Institutional Review Board |
Neurotransmitter Agents Adrenergic Agents Pain Nasal Decongestants Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Common Cold Phenylephrine Headache Vasoconstrictor Agents Analgesics Acetaminophen |
Pseudoephedrine Picornaviridae Infections Anti-Asthmatic Agents Central Nervous System Stimulants Cardiovascular Agents Virus Diseases Oxymetazoline Analgesics, Non-Narcotic Neurologic Manifestations Ephedrine Peripheral Nervous System Agents Bronchodilator Agents |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Physiological Effects of Drugs Pain Nasal Decongestants Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Common Cold Sensory System Agents Therapeutic Uses Headache Vasoconstrictor Agents |
Analgesics Acetaminophen Pseudoephedrine RNA Virus Infections Sympathomimetics Nervous System Diseases Anti-Asthmatic Agents Picornaviridae Infections Central Nervous System Stimulants Cardiovascular Agents Pharmacologic Actions Virus Diseases Autonomic Agents Analgesics, Non-Narcotic Neurologic Manifestations |