Common ColdPhase 4NCT01465009
Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold
A Phase 4 study testing Acetylsalicylic acid (Aspirin, BAYE4465) and Paracetamol in people with Common Cold and Pharyngitis, run by Bayer at 8 sites in United Kingdom.
Trial summary
The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (study medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of sore throat associated with a common cold. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Cold, Pharyngitis, Tonsillitis
- What is being tested?
- Acetylsalicylic acid (Aspirin, BAYE4465) and Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 508 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- Nov 2003to Mar 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients
- Onset of common cold within the past 5 days
- Current sore throat
- Confirmed presence of a tonsillo-pharyngitis
Who cannot join
- Hypersensitivity to acetylsalicylic acid, salicylates, paracetamol, or any other NSAID
- Pregnant or lactating women
- History or acute state of peptic ulceration or gastrointestinal bleeding
- History of bleeding tendency
- History of asthma
- Inability to breathe through the nose or a history of chronic mouth breathing
- Other exclusion criteria may apply
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Study site
Birmingham, West Midlands, B15 2SQ
Study site
Cardiff, South Glamorgan, CF1 3US
Study site
Chorley, Lancashire, PR7 1NY
Study site
Liverpool, Merseyside, L1 9AD
Study site
Liverpool, Merseyside, L22 0LG
Study site
Manchester, Greater Manchester, M15 6SX
Study site
Reading, Berkshire, RG2 7AG
Study site
Wigan, Lancashire, WN6 9EW
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Single Dose, Parallel Group Study Evaluating Efficacy and Safety of 1000 mg Acetylsalicylic Acid and 1000 mg Paracetamol in Adult Patients With Sore Throat Associated With a Common Cold
The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (study medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of sore throat associated with a common cold. The study is designed to develop a treatment method against sore throat associated with a common cold which will have more advantages for patients than the methods that are currently available.
- Conditions
- Common Cold, Pharyngitis, Tonsillitis
- Being tested
- Acetylsalicylic acid (Aspirin, BAYE4465), Paracetamol, Placebo
- Keywords
- Sore Throat
- Medical subject headings
- Common Cold, Pharyngitis, Tonsillitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acid (Aspirin, BAYE4465)Drug
Single Administration of 2 tablets Acetylsalicylic acid (500 mg each); in addition, 2 tablets matching placebo to Paracetamol
ParacetamolDrug
Single Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic Acid
PlaceboDrug
Single Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to Paracetamol
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Acetylsalicylic acid (Aspirin, BAYE4465) |
| Arm 2 | Active comparator | Not described Receives: Drug: Paracetamol |
| Arm 3 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol
Measured: For 6 hours after drug intake
Secondary outcomes (5)
Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo
Measured: For 6 hours after drug intake
Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol
Measured: For 6 hours after drug intake
Total pain relief of Acetylsalicylic Acid in comparison to Placebo
Measured: For 6 hours after drug intake
Evaluation of Upper Respiratory Tract Infection symtoms
Measured: 2 hours after drug intake
Adverse Event collection
Measured: Up to 17 days after Screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startNov 2003
- Study completionMar 2005
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
- 508 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
- NCT01465009
- Sponsor's protocol ID
- 11381
- Status last verified
- Nov 2011
- First submitted
- 17 May 2011
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Single Dose, Parallel Group Study Evaluating Efficacy and Safety of 1000 mg Acetylsalicylic Acid and 1000 mg Paracetamol in Adult Patients With Sore Throat Associated With a Common Cold
- ClinicalTrials.gov ID
- NCT01465009
- Acronym / sponsor ID
- 11381
- Conditions
- Common Cold, Pharyngitis, Tonsillitis
- Keywords
- Sore Throat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Mar 2005 (actual)
- First posted
- 4 Nov 2011 (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.
The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (study medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of sore throat associated with a common cold. The study is designed to develop a treatment method against sore throat associated with a common cold which will have more advantages for patients than the methods that are currently available.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Acetylsalicylic acid (Aspirin, BAYE4465) |
| Arm 2 | Active comparator | Drug: Paracetamol |
| Arm 3 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients
- Onset of common cold within the past 5 days
- Current sore throat
- Confirmed presence of a tonsillo-pharyngitis
Key exclusion criteria (7 listed)
- Hypersensitivity to acetylsalicylic acid, salicylates, paracetamol, or any other NSAID
- Pregnant or lactating women
- History or acute state of peptic ulceration or gastrointestinal bleeding
- History of bleeding tendency
- History of asthma
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 |
|---|---|---|
| Acetylsalicylic acid (Aspirin, BAYE4465)Single Administration of 2 tablets Acetylsalicylic acid (500 mg each); in addition, 2 tablets matching placebo to Paracetamol | Drug | Arm 1 |
| ParacetamolSingle Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic Acid | Drug | Arm 2 |
| PlaceboSingle Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to Paracetamol | Drug | Arm 3 |
Primary outcome
Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol
Time frame: For 6 hours after drug intake
5 secondary outcomes
Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo
Time frame: For 6 hours after drug intake
Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol
Time frame: For 6 hours after drug intake
Total pain relief of Acetylsalicylic Acid in comparison to Placebo
Time frame: For 6 hours after drug intake
Evaluation of Upper Respiratory Tract Infection symtoms
Time frame: 2 hours after drug intake
Adverse Event collection
Time frame: Up to 17 days after Screening
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 11 Dec 2014.
Related trials for Common Cold
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Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
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Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
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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
8 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 Acetylsalicylic acid (Aspirin, BAYE4465) and Paracetamol in people with Common Cold and Pharyngitis, run by Bayer at 8 sites in United Kingdom.
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 7 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 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. 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?
Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol (time frame: For 6 hours after drug intake). 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 11 Dec 2014; AzTrials last refreshed its copy on 30 Oct 2026.