Efficacy and Safety of Sinutab on Subjects in the Setting of a Common Cold
Information source: Pfizer
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Common Cold; Headache; Nasal Congestion
Intervention: Sinutab (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CTgov Call Center, Phone: 1-800-718-1021
Summary
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.
Clinical Details
Official title: A Community Pharmacy Based Investigation in the Self-Medication Area Efficacy and Safety of Sinutab [Paracetamol (500 mg) and Pseudoephedrine (30 mg)] on Subjects With Nasal Congestion Accompanied by Headache in the Setting of a Common Cold
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change in nasal congestion and headache.
Secondary outcome: Change in additional symptoms of common cold. (e.g. sore throat)Number of lost days at work/school
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Reported cold symptoms less than 48 hours to visit 1
A score of 2 or more for nasal congestion and headache, respectively, on an evaluation
scale
Exclusion Criteria:
Fever over 38 degrees centigrade (Celsius)
Locations and Contacts
Pfizer CTgov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Wilrijk, Antwerp, Belgium; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: February 2007
Last updated: November 19, 2007
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