Trial Condition(s):
Common Cold
Symptomatic treatment of common cold symptoms
Bayer Identifier:
11756
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations ASL Prov Varese - Lombardia Varese, Italy, 21100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr Mauro Pigni Fagnano Olona, Italy, 21054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Maurizio Viganò Vergiate, Italy, 21029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Claudio Bulla Capriate San Gervasio, Italy, 24042 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Luigi Donzelli Verdello, Italy, 24049 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Alessandro Filippi Mozzanica, Italy, 24050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr Raimondo Giuliana Brembate, Italy, 24041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr Sergio Nicoli Borgo di Terzo, Italy, 24060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Marina Pezzano Covo, Italy, 24050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Paola Pini Seriate, Italy, 24068 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr Francesco Rizza Cologno al Serio, Italy, 24055 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr Manuela Mariuz Dalmine, Italy, 24044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fagnano Olona, Italy, 21054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Calusco d'Adda, Italy, 24033 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cavaria, Italy, 21044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Cunardo, Italy, 21035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Mauro Calzolari Vedano Olona, Italy, 21040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Valter Colombo Solbiate Olona, Italy, 21058 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr Marco Passamonti Fagnano Olona, Italy, 21054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Vincenzo Spada Induno Olona, Italy, 21056 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Ettore Mantione Cologno al Serio, Italy, 24055 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Claudio Mascaretti Caravaggio, Italy, 24043 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Fabio Villa Villa d'Adda, Italy, 24030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ambulatorio Dr. Mario Zappa Casazza, Italy, 24060 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Angera, Italy, 21021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sesto Calende, Italy, 21018 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Comerio, Italy, 21025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Carnago, Italy, 21040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ponte San Pietro, Italy, 24036 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vertova, Italy, 24029 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albano Sant'Alessandro, Italy, 24061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baselineTimeframe: 2 hours following intake of the first study medication dose
Secondary Outcome
- Changes in Common Cold Profile (sum of WURSS domains 1 182 3)Timeframe: 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)
- Changes in Global Cold Severity (WURSS domain 1)Timeframe: 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)
- Changes in Cold Symptoms (WURSS domain 2)Timeframe: 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)
- Changes in Cold-specific Functional Impairments (WURSS domain 3)Timeframe: 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)
- Changes in Global Cold Severity (WURSS domain 4)Timeframe: 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)
- Adverse Event CollectionTimeframe: Until end of study
Additional Information
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