Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold - Full Text View

Sponsored by:	Johnson & Johnson Consumer & Personal Products Worldwide
Information provided by:	Johnson & Johnson Consumer & Personal Products Worldwide
ClinicalTrials.gov Identifier:	NCT00378144

Purpose

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
Common Cold Headache Nasal Congestion	Drug: Pseudoephedrine/Paracetamol	Phase IV

MedlinePlus related topics: Common Cold Headache

Drug Information available for: Acetaminophen

U.S. FDA Resources

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

Further study details as provided by Johnson & Johnson Consumer & Personal Products Worldwide:

Primary Outcome Measures:

Change from baseline in the sum of nasal congestion and headache sign/symptom scores [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in the mean MSC score over the treatment days. The MSC score is defined as the sum of nasal congestion, headache, sore throat, and pressure around the eyes sign/symptom scores [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Change from baseline in the mean individual sign/symptom score, including nasal congestion, headache, sore throat, and pressure around the eyes [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Number of lost days at work or school [ Time Frame: 7 Days ] [ Designated as safety issue: No ]
Mean scores for: (a) interference with concentration; and (b) interference with sleep for days during treatment with study medication only [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Safety evaluation by adverse event recording [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Exploratory Endpoint: time to reach the first of two consecutive total Modified Jackson Subject Evaluation Scale (MJS) scores (defined as sum of 8 signs/symptoms) ≤ 1 [ Time Frame: Up to seven days ] [ Designated as safety issue: No ]

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
1: Experimental Pseudoephedrine/Paracetamol	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)]

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age 18 years or more
reported cold symptoms beginning ≤ 48 hours prior to visit 1
scored ≥ 2 for each of nasal congestion and headache using the Modified Jackson Subject Evaluation Scale
willing and able to comply with scheduled visits, treatment plan, and other study procedures
evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial

Exclusion Criteria:

patients without an electronic medication record in the pharmacy
history of hypersensitivity to paracetamol or pseudoephedrine or lactose
fever more than 38.0°C (measured by pharmacist)
women in the fertile years who do not use a hormonal contraception or an intra-uterine device
use of concomitant drugs, medications or treatments that could interfere with the study drug
important intercurrent medical condition based on the available medication record of the patient. (cf. exclusion criterium 1)
history of nasal reconstructive surgery
alcohol and/or drug abuse within a 6-month period immediately preceding the screening visit
any 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 study personnel, would make the subject inappropriate for inclusion
participation in other clinical trials the last three months and during study participation.
employees of the clinical research centers, sponsor, the CRO's contracted for this study, or their immediate family members

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378144

Locations

Belgium, Antwerp
JJCPPW Investigational Site
Wilrijk, Antwerp, Belgium

Sponsors and Collaborators

Johnson & Johnson Consumer & Personal Products Worldwide

Investigators

Study Director:

Elisabeth A Kruse, PhD

JJCPPW

More Information

Responsible Party:	JJCPPW ( Joyce Hauze/Senior Project Manager )
Study ID Numbers:	A7801002
Study First Received:	September 5, 2006
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00378144
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Pseudoephedrine
Picornaviridae Infections
Pain
Naphazoline
Virus Diseases
Oxymetazoline
Signs and Symptoms
Respiratory Tract Infections
Respiratory Tract Diseases

Guaifenesin
Common Cold
Phenylephrine
Headache
Neurologic Manifestations
Ephedrine
Phenylpropanolamine
Acetaminophen

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Nervous System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Central Nervous System Stimulants
Cardiovascular Agents

Pharmacologic Actions
Nasal Decongestants
Autonomic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Analgesics
Peripheral Nervous System Agents
Bronchodilator Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009