Symptomatic Treatment of Common Cold Symptoms

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01033526
• Collaborator: (none)
• Enrollment: 388
• Locations: 28
• Arms: 2
• Duration (Months): 20
• Patients Per Site: 13.9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Common Cold	Drug: Aspirin (Acetylsalicylic acid, BAYE4465); Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 388 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: Oct 1, 2005
• Actual Study Completion Date: Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline [2 hours following intake of the first study medication dose]

Secondary Outcome Measures

1. Changes in Common Cold Profile (sum of WURSS domains 1 182 3) [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)]

2. Changes in Global Cold Severity (WURSS domain 1) [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)]

3. Changes in Cold Symptoms (WURSS domain 2) [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)]

4. Changes in Cold-specific Functional Impairments (WURSS domain 3) [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)]

5. Changes in Global Cold Severity (WURSS domain 4) [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)]

6. Adverse Event Collection [Until end of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Borgo Di Terzo	Bergamo	Italy	24060
2		Brembate	Bergamo	Italy	24041
3		Calusco d'Adda	Bergamo	Italy	24033
4		Capriate San Gervasio	Bergamo	Italy	24042
5		Caravaggio	Bergamo	Italy	24043
6		Casazza	Bergamo	Italy	24060
7		Cologno Al Serio	Bergamo	Italy	24055
8		Covo	Bergamo	Italy	24050
9		Dalmine	Bergamo	Italy	24044
10		Mozzanica	Bergamo	Italy	24050
11		Ponte San Pietro	Bergamo	Italy	24036
12		Seriate	Bergamo	Italy	24068
13		Verdello	Bergamo	Italy	24049
14		Vertova	Bergamo	Italy	24029
15		Villa d'Adda	Bergamo	Italy	24030
16		Angera	Varese	Italy	21021
17		Carnago	Varese	Italy	21040
18		Cavaria	Varese	Italy	21044
19		Comerio	Varese	Italy	21025
20		Cunardo	Varese	Italy	21035
21		Fagnano Olona	Varese	Italy	21054
22		Induno Olona	Varese	Italy	21056
23		Sesto Calende	Varese	Italy	21018
24		Solbiate Olona	Varese	Italy	21058
25		Vedano Olona	Varese	Italy	21040
26		Vergiate	Varese	Italy	21029
27		Albano Sant'Alessandro		Italy	24061
28		Varese		Italy	21100

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01033526
• Other Study ID Numbers: 11756; EudraCT: 2004-004683-71
• First Posted: Dec 16, 2009
• Last Update Posted: Dec 16, 2009
• Last Verified: Dec 1, 2009

• Keywords provided by , ,: Symptomatic treatment of Common Cold symptoms
• Additional relevant MeSH terms: Common Cold; Aspirin

Study Results

No Results Posted as of Dec 16, 2009