check_circleStudy Completed
Common Cold
Bayer Identifier:
11756
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Symptomatic treatment of common cold symptoms
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.
Key Participants Requirements
Sex
BothAge
18 - 65 YearsTrial summary
Enrollment Goal
388Trial Dates
October 2005 - June 2007Phase
Phase 4Could I Receive a placebo
YesProducts
Aspirin (Acetylsalicylic Acid, BAYE4465)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | ASL Prov Varese - Lombardia | Varese, 21100, Italy |
Completed | Ambulatorio Dr Mauro Pigni | Fagnano Olona, 21054, Italy |
Completed | Ambulatorio Dr. Maurizio Viganò | Vergiate, 21029, Italy |
Completed | Ambulatorio Dr. Claudio Bulla | Capriate San Gervasio, 24042, Italy |
Completed | Ambulatorio Dr. Luigi Donzelli | Verdello, 24049, Italy |
Completed | Ambulatorio Dr. Alessandro Filippi | Mozzanica, 24050, Italy |
Completed | Ambulatorio Dr Raimondo Giuliana | Brembate, 24041, Italy |
Completed | Ambulatorio Dr Sergio Nicoli | Borgo di Terzo, 24060, Italy |
Completed | Ambulatorio Dr. Marina Pezzano | Covo, 24050, Italy |
Completed | Ambulatorio Dr. Paola Pini | Seriate, 24068, Italy |
Completed | Ambulatorio Dr Francesco Rizza | Cologno al Serio, 24055, Italy |
Completed | Ambulatorio Dr Manuela Mariuz | Dalmine, 24044, Italy |
Completed | Fagnano Olona, 21054, Italy | |
Completed | Calusco d'Adda, 24033, Italy | |
Completed | Cavaria, 21044, Italy | |
Completed | Cunardo, 21035, Italy | |
Completed | Ambulatorio Dr. Mauro Calzolari | Vedano Olona, 21040, Italy |
Completed | Ambulatorio Dr. Valter Colombo | Solbiate Olona, 21058, Italy |
Completed | Ambulatorio Dr Marco Passamonti | Fagnano Olona, 21054, Italy |
Completed | Ambulatorio Dr. Vincenzo Spada | Induno Olona, 21056, Italy |
Completed | Ambulatorio Dr. Ettore Mantione | Cologno al Serio, 24055, Italy |
Completed | Ambulatorio Dr. Claudio Mascaretti | Caravaggio, 24043, Italy |
Completed | Ambulatorio Dr. Fabio Villa | Villa d'Adda, 24030, Italy |
Completed | Ambulatorio Dr. Mario Zappa | Casazza, 24060, Italy |
Completed | Angera, 21021, Italy | |
Completed | Sesto Calende, 21018, Italy | |
Completed | Fagnano Olona, 21054, Italy | |
Completed | Comerio, 21025, Italy | |
Completed | Carnago, 21040, Italy | |
Completed | Ponte San Pietro, 24036, Italy | |
Completed | Vertova, 24029, Italy | |
Completed | Albano Sant'Alessandro, 24061, Italy |
Primary Outcome
- Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baselinedate_rangeTime Frame:2 hours following intake of the first study medication doseenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Changes in Common Cold Profile (sum of WURSS domains 1 182 3)date_rangeTime 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)enhanced_encryptionnoSafety Issue:
- Changes in Global Cold Severity (WURSS domain 1)date_rangeTime 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)enhanced_encryptionnoSafety Issue:
- Changes in Cold Symptoms (WURSS domain 2)date_rangeTime 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)enhanced_encryptionnoSafety Issue:
- Changes in Cold-specific Functional Impairments (WURSS domain 3)date_rangeTime 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)enhanced_encryptionnoSafety Issue:
- Changes in Global Cold Severity (WURSS domain 4)date_rangeTime 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)enhanced_encryptionnoSafety Issue:
- Adverse Event Collectiondate_rangeTime Frame:Until end of studyenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2