Common ColdPhase 4NCT01033526
Symptomatic Treatment of Common Cold Symptoms
A Phase 4 study testing Aspirin (Acetylsalicylic acid, BAYE4465) in people with Common Cold, run by Bayer at 28 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Common Cold
- What is being tested?
- Aspirin (Acetylsalicylic acid, BAYE4465)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 28 sitesItaly
- Study dates
- Oct 2005to Jun 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
28 sites in 1 country.
28 sites in 1 country
Italy28 sites
Study site
Albano Sant'Alessandro, 24061
Study site
Angera, Varese, 21021
Study site
Borgo di Terzo, Bergamo, 24060
Study site
Brembate, Bergamo, 24041
Study site
Calusco d'Adda, Bergamo, 24033
Study site
Capriate San Gervasio, Bergamo, 24042
Study site
Caravaggio, Bergamo, 24043
Study site
Carnago, Varese, 21040
Study site
Casazza, Bergamo, 24060
Study site
Cavaria, Varese, 21044
Study site
Cologno al Serio, Bergamo, 24055
Study site
Comerio, Varese, 21025
Study site
Covo, Bergamo, 24050
Study site
Cunardo, Varese, 21035
Study site
Dalmine, Bergamo, 24044
Study site
Fagnano Olona, Varese, 21054
Study site
Induno Olona, Varese, 21056
Study site
Mozzanica, Bergamo, 24050
Study site
Ponte San Pietro, Bergamo, 24036
Study site
Seriate, Bergamo, 24068
Study site
Sesto Calende, Varese, 21018
Study site
Solbiate Olona, Varese, 21058
Study site
Varese, Varese, 21100
Study site
Vedano Olona, Varese, 21040
Study site
Verdello, Bergamo, 24049
Study site
Vergiate, Varese, 21029
Study site
Vertova, Bergamo, 24029
Study site
Villa d'Adda, Bergamo, 24030
About this study
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
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.
- Conditions
- Common Cold
- Being tested
- Aspirin (Acetylsalicylic acid, BAYE4465), Placebo
- Keywords
- Symptomatic treatment of Common Cold symptoms
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin (Acetylsalicylic acid, BAYE4465)Drug
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
PlaceboDrug
1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 1 | Experimental | Not described Receives: Drug: Aspirin (Acetylsalicylic acid, BAYE4465) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline
Measured: 2 hours following intake of the first study medication dose
Secondary outcomes (6)
Changes in Common Cold Profile (sum of WURSS domains 1 182 3)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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 Collection
Measured: Until end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2009 (estimated)
- Study startOct 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033526
- Sponsor's protocol ID
- 11756
- Other IDs
- EudraCT: 2004-004683-71
- Status last verified
- Dec 2009
- First submitted
- 15 Dec 2009
- Last updated
- 16 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01033526
- Acronym / sponsor ID
- 11756
- Conditions
- Common Cold
- Keywords
- Symptomatic treatment of Common Cold symptoms
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 388 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Study completion
- Jun 2007 (actual)
- First posted
- 16 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Placebo comparator | Drug: Placebo |
| Arm 1 | Experimental | Drug: Aspirin (Acetylsalicylic acid, BAYE4465) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Arm 1 |
| Placebo1-2 tablets matching Placebo as needed every 4-6 hours over a maximum of 5 days | Drug | Arm 2 |
Primary outcome
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
6 secondary outcomes
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)
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)
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)
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)
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)
Adverse Event Collection
Time frame: Until end of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin (Acetylsalicylic acid, BAYE4465) in people with Common Cold, run by Bayer at 28 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2009.