Common ColdPhase 3NCT01062360
Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
A Phase 3 study testing Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine, Acetylsalicylic Acid (Aspirin, BAYE4465) and Pseudoephedrine in people with Common Cold and Pharyngitis, run by Bayer at 59 sites in 4 countries.
Trial summary
The purpose of this study is compare efficacy and tolerability of a fixed combination, containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Common Cold, Pharyngitis
- What is being tested?
- Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine, Acetylsalicylic Acid (Aspirin, BAYE4465) and Pseudoephedrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,016 participants
- Where
- 59 sitesin 4 countries
- Study dates
- 23 Dec 2005to 14 May 2007
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:- Male and female subjects between 18 and 65 years of age.- Onset of cold symptoms within 96 hours (4 days) before study participation.- Current complaint of at least moderate sore throat at baseline- Current complaint of at least moderate NC at baseline- History of other symptoms associated with URTI during the last 4 days before study participation.- Other findings of URTI, confirmed on the physical examination.- Agreement to comply with the study requirements.- Written informed consent prior to enrollment in the study Exclusion Criteria:- Pregnant or lactating females.- Uncontrolled chronic diseases.- History of hypersensitivity (allergic reaction) to ASA, any other nonsteroidal anti-inflammatory drugs (NSAIDs), or PSE.- Any disease which significantly compromises breathing or interferes with the subjects assessment of sore throat.- History of or active peptic ulcer.- Severe impaired hepatic function.- Severe impaired renal function.- Simultaneous intake of monoamine oxidase inhibitors.- Use of menthol containing tissues within 2 hours before first intake of study drug.- Intake of any menthol containing product within 4 hours before first intake of study drug.- Use of any local or systemic short acting cough and cold preparations within 6 hours before first intake of study drug.- Use of any local or systemic long acting cough and cold preparations within 12 hours before first intake of study drug.- Intake of any analgesic within 12 hours before first intake of study drug.- Intake or requirement of any prescription medication for the treatment of the current acute respiratory tract infection.- Current or previous intake of anticoagulants, corticoids, NSAIDs, methotrexate, or lithium.- Participation in another clinical trial within the last 30 days.
Trial locations and contacts
59 sites in 4 countries.
59 sites in 4 countries
Italy29 sites
Study site
Alassio, 17021
Study site
Albenga, 17031
Study site
Arenzano, 16011
Study site
Civitella Marittima, 58048
Study site
Follonica, 58022
Study site
Genova, 16010
Study site
Genova, 16125
Study site
Genova, 16128
Study site
Genova, 16129
Study site
Genova, 16131
Study site
Genova, 16137
Study site
Genova, 16143
Study site
Genova, 16149
Study site
Genova, 16161
Study site
Genova, 16162
Study site
Grosseto, 58100
Study site
Grossetto, 58100
Study site
Isola del Cantone, 16017
Study site
Loano, 17025
Study site
Masone, 16010
Study site
Orbetello, 58100
Study site
Pegli, 16100
Study site
Quiliano, 17047
Study site
Rivarolo, 16150
Study site
Ronco Scrivia, 16019
Study site
Sampierdarena, 16151
Study site
Scansano, 58054
Study site
Serra Riccò, 16010
Study site
Varazze, 17019
Poland19 sites
Study site
Ciechocin, 87-408
Study site
Dębowa Góra, 96-116
Study site
Katowice, 40-226
Study site
Katowice, 40-520
Study site
Katowice, 40-752
Study site
Krakow, 31-215
Study site
Lodz, 93-105
Study site
Piaseczno, 05-500
Study site
Skierniewice, 96-100
Study site
Szczecin, 71-140
Study site
Szczecin, 71-502
Study site
Torun, 87-100
Study site
Warsaw, 01-493
Study site
Warsaw, 01-961
Study site
Warsaw, 02-091
Study site
Warsaw, 02-097
Study site
Warsaw, 02-793
Study site
Warsaw, 03-185
Study site
Zabrze, 41-800
Slovakia9 sites
Study site
Bratislava, 81107
Study site
Bratislava, 84101
Study site
Bratislava, 84104
Study site
Bratislava, 84107
Study site
Bratislava, 85101
Study site
Bratislava, 85102
Study site
Bratislava, 85105
Study site
Pezinok, 90201
Study site
Stupava, 90031
United States2 sites
Study site
New York, New York, 11021
Study site
New York, New York, 11743
About this study
Official title: A Pivotal, Placebo Controlled, Phase III Study to Compare Efficacy and Tolerability of a Fixed Combination, Containing 500 mg ASA and 30 mg Pseudoephedrine, in Comparison to Its Single Components in Patients With Sore Throat and Nasal Congestion
The purpose of this study is compare efficacy and tolerability of a fixed combination, containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion.
- Conditions
- Common Cold, Pharyngitis
- Being tested
- Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine, Acetylsalicylic Acid (Aspirin, BAYE4465), Pseudoephedrine, Placebo
- Keywords
- Sore Throat, Upper Respiratory Tract Infections, Nasal Congestion
- Medical subject headings
- Common Cold, Pharyngitis, Respiratory Tract Infections, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + PseudoephedrineDrug
Single oral dose of 1 to 2 Aspirin Complex sachets, each containing granules of 500 mg Acetylsalicylic Acid (ASA) and 30 mg Pseudoephedrine (PSE), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Acetylsalicylic Acid (Aspirin, BAYE4465)Drug
Single oral dose of 1 to 2 sachets Acetylsalicylic Acid, each containing granules of 500 mg Acetylsalicylic Acid (ASA), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
PseudoephedrineDrug
Single oral dose of 1 to 2 sachets Pseudoephedrine, each containing granules 30 mg Pseudoephedrine, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
PlaceboDrug
Single oral dose of 1 to 2 sachets, each containing Placebo granules, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + 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.
The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing
Measured: 2 hours
The primary efficacy parameter for sore throat was SPID2 hours
Measured: 2 hours
Secondary outcomes (10)
The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose
Measured: 15, 30, 60, 90, 120, 240, and 360 minutes
The Nasal Congestion Score
Measured: 15, 30, 60, 90, 120, 240, and 360 minutes
The Nasal Congestion Relief Score
Measured: 15, 30, 60, 90, 120, 240, and 360 minutes
Sore throat pain relief
Measured: 15, 30, 60, 90, 120, 240, and 360 minutes
The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dose
Measured: 120 minutes
The results of an overall assessment of treatment by the subjects at 120 minutes post dose
Measured: 120 minutes
The results of an overall assessment of treatment by the subjects at the end of Day 3 after the first dose, or at the end of treatment (6 hours after last dose of study drug)
Measured: Day 3
Nasal Congestion, Pain Intensity Difference and pain relief at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake)
Measured: Day 3
The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake)
Measured: Day 2 and Day 3
Total amount of drug intake
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study start23 Dec 2005
- Primary completion14 May 2007
- Study completion14 May 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,016 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
- NCT01062360
- Sponsor's protocol ID
- 11764
- Other IDs
- 2005-001720-36, 2005
- Status last verified
- Aug 2017
- First submitted
- 9 Dec 2009
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Placebo Controlled, Phase III Study to Compare Efficacy and Tolerability of a Fixed Combination, Containing 500 mg ASA and 30 mg Pseudoephedrine, in Comparison to Its Single Components in Patients With Sore Throat and Nasal Congestion
- ClinicalTrials.gov ID
- NCT01062360
- Acronym / sponsor ID
- 11764
- Conditions
- Common Cold, Pharyngitis
- Keywords
- Sore Throat, Upper Respiratory Tract Infections, Nasal Congestion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,016 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2005 (actual)
- Primary completion
- 14 May 2007 (actual)
- Study completion
- 14 May 2007 (actual)
- First posted
- 4 Feb 2010 (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 compare efficacy and tolerability of a fixed combination, containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + 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 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 Complex, BAYE4465) + PseudoephedrineSingle oral dose of 1 to 2 Aspirin Complex sachets, each containing granules of 500 mg Acetylsalicylic Acid (ASA) and 30 mg Pseudoephedrine (PSE), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days. | Drug | Arm 1 |
| Acetylsalicylic Acid (Aspirin, BAYE4465)Single oral dose of 1 to 2 sachets Acetylsalicylic Acid, each containing granules of 500 mg Acetylsalicylic Acid (ASA), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days. | Drug | Arm 2 |
| PseudoephedrineSingle oral dose of 1 to 2 sachets Pseudoephedrine, each containing granules 30 mg Pseudoephedrine, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days. | Drug | Arm 3 |
| PlaceboSingle oral dose of 1 to 2 sachets, each containing Placebo granules, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days. | Drug | Arm 4 |
Primary outcome
The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing
Time frame: 2 hours
The primary efficacy parameter for sore throat was SPID2 hours
Time frame: 2 hours
10 secondary outcomes
The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose
Time frame: 15, 30, 60, 90, 120, 240, and 360 minutes
The Nasal Congestion Score
Time frame: 15, 30, 60, 90, 120, 240, and 360 minutes
The Nasal Congestion Relief Score
Time frame: 15, 30, 60, 90, 120, 240, and 360 minutes
Sore throat pain relief
Time frame: 15, 30, 60, 90, 120, 240, and 360 minutes
The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dose
Time frame: 120 minutes
The results of an overall assessment of treatment by the subjects at 120 minutes post dose
Time frame: 120 minutes
The results of an overall assessment of treatment by the subjects at the end of Day 3 after the first dose, or at the end of treatment (6 hours after last dose of study drug)
Time frame: Day 3
Nasal Congestion, Pain Intensity Difference and pain relief at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake)
Time frame: Day 3
The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake)
Time frame: Day 2 and Day 3
Total amount of drug intake
Time frame: Day 3
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 1 Sep 2017.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink 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
59 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine, Acetylsalicylic Acid (Aspirin, BAYE4465) and Pseudoephedrine in people with Common Cold and Pharyngitis, run by Bayer at 59 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in Italy, Poland, Slovakia, United States. 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?
The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 1 Sep 2017.