Common ColdPhase 3NCT00963443
Acetylsalicylic Acid Combined With Pseudoephedrine in Common Cold
A Phase 3 study testing Acetylsalicylic Acid (Aspirin, BAYE4465) and Pseudoephedrine in people with Common Cold, run by Bayer at 1 site in United Kingdom.
Trial summary
The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Common Cold
- What is being tested?
- Acetylsalicylic Acid (Aspirin, BAYE4465) and Pseudoephedrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 833 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2009to Mar 2012
- Phase
- Phase 3
- 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
- Patient in general good health with suspected viral upper respiratory tract infection (common cold)
Who cannot join
- < 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Acetylsalicylic Acid Combined With Pseudoephedrine, Compared With Acetylsalicylic Acid Alone, and Pseudoephedrine Alone, on Symptoms of Pain.
The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.
- Conditions
- Common Cold
- Being tested
- Acetylsalicylic Acid (Aspirin, BAYE4465), Pseudoephedrine, Placebo
- Keywords
- Aspirin Complex, Acetylsalicylic Acid, Pseudoephedrine, Common Cold
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic Acid (Aspirin, BAYE4465)Drug
2 Sachets of 500 mg Aspirin Complex.
PseudoephedrineDrug
2 Sachets of 30 mg Pseudoephedrine
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Drug: Pseudoephedrine |
| Arm 2 | Active comparator | Not described Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) |
| Arm 3 | Active comparator | Not described Receives: Drug: Pseudoephedrine |
| Arm 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of nasal congestion and relief of pain
Measured: 4 hours
Secondary outcomes (8)
Area under the curve for nasal airflow conductance from baseline
Measured: 1h, 2h, 3h
Sum of subjective nasal congestion intensity differences
Measured: 1h, 2h, 3h, 4h and 1, 2, 3 days
Total subjective nasal congestion relief
Measured: 1h, 2h, 3h,4 h and 1, 2, 3 days
Global assessment of nasal congestion
Measured: 3 days
Global assessment of pain relief
Measured: 3 days
Sum of pain intensity differences
Measured: 1h, 2h, 3h, 4h and 1, 2, 3 days
Total pain relief
Measured: 1, 2, 3 days
Adverse Event collection and physical examination
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2012
- Study completionMar 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 833 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963443
- Sponsor's protocol ID
- 13700
- Other IDs
- 2009-011355-46, 2009
- Status last verified
- Dec 2014
- First submitted
- 20 Aug 2009
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Acetylsalicylic Acid Combined With Pseudoephedrine, Compared With Acetylsalicylic Acid Alone, and Pseudoephedrine Alone, on Symptoms of Pain.
- ClinicalTrials.gov ID
- NCT00963443
- Acronym / sponsor ID
- 13700
- Conditions
- Common Cold
- Keywords
- Aspirin Complex, Acetylsalicylic Acid, Pseudoephedrine, Common Cold
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 833 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Aug 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.
The purpose of the study is to determine the effectiveness of an acetylsalicylic acid (aspirin) pseudoephedrine combination for the treatment of pain and congestion symptoms compared to the effectiveness of the individual components of the medicine and the placebo (dummy treatment that looks like the real thing).The combination product of acetylsalicylic acid / pseudoephedrine is already marketed in several European countries as Aspirin® Complex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465), Drug: Pseudoephedrine |
| Arm 2 | Active comparator | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) |
| Arm 3 | Active comparator | Drug: Pseudoephedrine |
| Arm 4 | 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 (1 listed)
- Patient in general good health with suspected viral upper respiratory tract infection (common cold)
Key exclusion criteria (1 listed)
- < 18 years old
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)2 Sachets of 500 mg Aspirin Complex. | Drug | Arm 1, Arm 2 |
| Pseudoephedrine2 Sachets of 30 mg Pseudoephedrine | Drug | Arm 1, Arm 3 |
| PlaceboMatching Placebo | Drug | Arm 4 |
Primary outcome
Reduction of nasal congestion and relief of pain
Time frame: 4 hours
8 secondary outcomes
Area under the curve for nasal airflow conductance from baseline
Time frame: 1h, 2h, 3h
Sum of subjective nasal congestion intensity differences
Time frame: 1h, 2h, 3h, 4h and 1, 2, 3 days
Total subjective nasal congestion relief
Time frame: 1h, 2h, 3h,4 h and 1, 2, 3 days
Global assessment of nasal congestion
Time frame: 3 days
Global assessment of pain relief
Time frame: 3 days
Sum of pain intensity differences
Time frame: 1h, 2h, 3h, 4h and 1, 2, 3 days
Total pain relief
Time frame: 1, 2, 3 days
Adverse Event collection and physical examination
Time frame: 3 days
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 5 Dec 2014.
- Click here and search for EMA Websynopsis resultsLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic Acid (Aspirin, BAYE4465) and Pseudoephedrine in people with Common Cold, run by Bayer at 1 site 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 1 inclusion and 1 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 5 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 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Reduction of nasal congestion and relief of pain (time frame: 4 hours). 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 5 Dec 2014.