Symptomatic Treatment of Common Cold Symptoms - Full Text View

Purpose

A two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel groups study evaluating efficacy and tolerability of 800 mg Acetylsalicylic Acid (Aspirina C) in adult patients with a common cold during a two hour in patient phase; and a follow-up period of five days of home treatment as required.

Condition	Intervention	Phase
Common Cold	Drug: Aspirin (Acetylsalicylic acid, BAYE4465) Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Two-arm, Multicenter, Randomized, Double-blind, Single Dose Placebo-controlled Parallel Groups Study Evaluating Efficacy and Tolerability of 800 mg Acetylsalicylic Acid (Aspirina® C) in Adult Patients With a Common Cold During a Two Hour in Patient Phase; and a Follow-up Period of Five Days of Home Treatment as Required

Resource links provided by NLM:

MedlinePlus related topics: Common Cold

Drug Information available for: Aspirin

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline [ Time Frame: 2 hours following intake of the first study medication dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in Common Cold Profile (sum of WURSS domains 1 182 3) [ Time Frame: At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) ] [ Designated as safety issue: No ]
Changes in Global Cold Severity (WURSS domain 1) [ Time Frame: At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) ] [ Designated as safety issue: No ]
Changes in Cold Symptoms (WURSS domain 2) [ Time Frame: At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) ] [ Designated as safety issue: No ]
Changes in Cold-specific Functional Impairments (WURSS domain 3) [ Time Frame: At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) ] [ Designated as safety issue: No ]
Changes in Global Cold Severity (WURSS domain 4) [ Time Frame: At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period) ] [ Designated as safety issue: No ]
Adverse Event Collection [ Time Frame: Until end of study ] [ Designated as safety issue: Yes ]

Enrollment:	388
Study Start Date:	October 2005
Study Completion Date:	June 2007

Arms	Assigned Interventions
Placebo Comparator: Arm 2	Drug: Placebo 1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days
Experimental: Arm 1	Drug: Aspirin (Acetylsalicylic acid, BAYE4465) 1-2 tablets Acetylsalicylic Acid 400 mg (in combination with Ascorbic Acid 240 mg) as needed every 4-6 hours over a maximum of 5 days

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 18 and 65 years
Onset of cold symptoms within 48 hours before screening
Objective symptoms of common cold
Subjective symptoms of common cold

Exclusion Criteria:

Pregnancy or lactation period
Active peptic ulcer
Hemorrhagic diathesis
History of chronic or recurrent ulcer disease or history of gastro-intestinal bleeding
Hypersensitivity to acetylsalicylic acid, to paracetamol, to any other component of the study medication, to anti-inflammatory or antirheumatic drugs, to other allergens

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033526

Locations

Italy

Borgo Di Terzo, Bergamo, Italy, 24060

Brembate, Bergamo, Italy, 24041

Calusco d'Adda, Bergamo, Italy, 24033

Capriate San Gervasio, Bergamo, Italy, 24042

Caravaggio, Bergamo, Italy, 24043

Casazza, Bergamo, Italy, 24060

Cologno Al Serio, Bergamo, Italy, 24055

Covo, Bergamo, Italy, 24050

Dalmine, Bergamo, Italy, 24044

Mozzanica, Bergamo, Italy, 24050

Ponte San Pietro, Bergamo, Italy, 24036

Seriate, Bergamo, Italy, 24068

Verdello, Bergamo, Italy, 24049

Vertova, Bergamo, Italy, 24029

Villa d'Adda, Bergamo, Italy, 24030

Angera, Varese, Italy, 21021

Carnago, Varese, Italy, 21040

Cavaria, Varese, Italy, 21044

Comerio, Varese, Italy, 21025

Cunardo, Varese, Italy, 21035

Fagnano Olona, Varese, Italy, 21054

Induno Olona, Varese, Italy, 21056

Sesto Calende, Varese, Italy, 21018

Solbiate Olona, Varese, Italy, 21058

Vedano Olona, Varese, Italy, 21040

Vergiate, Varese, Italy, 21029

Albano Sant'Alessandro, Italy, 24061

Varese, Italy, 21100

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier:	NCT01033526 History of Changes
Other Study ID Numbers:	11756, EudraCT: 2004-004683-71
Study First Received:	December 15, 2009
Last Updated:	December 15, 2009
Health Authority:	Italy: Ethics Committee

Keywords provided by Bayer:

Symptomatic treatment of Common Cold symptoms

Additional relevant MeSH terms:

Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 18, 2013