Respiratory Tract InfectionsPhase 4NCT01464944
Placebo and Active Controlled Study to Compare the Antipyretic Efficacy of Aspirin® in Patients With Acute Febrile Upper Respiratory Tract Infections Suspected to be of Viral Origin
A Phase 4 study testing Acetylsalicylic acid (Aspirin, BAYE4465) and Paracetamol in people with Respiratory Tract Infections and Fever, run by Bayer at 9 sites in 2 countries.
Trial summary
This study is addressed to patients suffering from an acute febrile upper respiratory tract infection suspected to be of viral origin. The purpose of this study is to determine the antipyretic efficacy (reduction of fever by lowering the body temperature from a raised state) of Aspirin in doses of 500 and 1000 mg… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Respiratory Tract Infections, Fever
- 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
- 392 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Nov 2003to Apr 2004
- 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
- Ambulatory male or female patients 18 to 65 years of age
- Acute uncomplicated febrile URTI suspected to be of viral origin and present not more than 5 days
- Symptoms of a viral URTI
- Oral temperature >/= 38.5 °C to </= 40°C
Who cannot join
- Patients with physical findings consistent with the diagnosis of pneumonia, otitis media, bacterial sinusitis or any other bacterial infection of the respiratory tract requiring antibiotics or other therapeutic intervention by a physician
- Current antibiotic treatment or pre-treatment with antibiotic agents during the last week
- History or presence of asthma or hypersensitivity to ASA, salicylates, paracetamol, or other non-steroidal anti-inflammatory drugs; peptic ulceration or gastric bleeding; hemorrhagic diathesis; hepatic and/or renal dysfunction; Gilbert's disease; Quincke's edema
- Any other acute or chronic disease which in the opinion f the investigator could interfere with the patient's health and well-being during the conduct of the study or which could interfere with the evaluation of data generated from this subject
- Any conditions possibly interfering with the gastro-intestinal absorption of the study medication
- Pregnant or lactating women. All women of childbearing age were to undergo a pregnancy test before start of the study
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Russia6 sites
Study site
Moscow, 105064
Study site
Moscow, 107996
Study site
Moscow, 109386
Study site
Moscow, 125183
Study site
Moscow, 127015
Study site
Moscow, 127299
Ukraine3 sites
Study site
Kiev, 02232
Study site
Kiev, 03049
Study site
Luhansk, 91011
About this study
Official title: A Randomized, Double-blind, Double-dummy, Single-dose, Parallel Group, Multicenter Study to Compare the Antipyretic Efficacy of Acetylsalicy-lic Acid 500 mg and 1,000 mg (2 x 500 mg) and Paracetamol 500 mg and 1,000 mg (2 x 500 mg) With Placebo in Patients With Acute Febrile Upper Respiratory Tract Infections Suspected to be of Viral Origin.
This study is addressed to patients suffering from an acute febrile upper respiratory tract infection suspected to be of viral origin. The purpose of this study is to determine the antipyretic efficacy (reduction of fever by lowering the body temperature from a raised state) of Aspirin in doses of 500 and 1000 mg (study medication) compared to the one of Paracetamol in doses of 500 and 1000 mg (comparator medication) as well as the one of Placebo (comparator medication without an active substance). Despite of its common use for fever treatment, the scientific data in adults which support the antipyretic efficacy of Aspirin are sparse. Therefore, the purpose of this study is to collect such data.
- Conditions
- Respiratory Tract Infections, Fever
- Being tested
- Acetylsalicylic acid (Aspirin, BAYE4465), Paracetamol, Placebo
- Keywords
- Upper Respiratory Tract Infections
- Medical subject headings
- Respiratory Tract Infections, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acid (Aspirin, BAYE4465)Drug
Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol
Acetylsalicylic acid (Aspirin, BAYE4465)Drug
Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Paracetamol
ParacetamolDrug
Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid
ParacetamolDrug
Paracetamol 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
PlaceboDrug
2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose
| Study group | Role | What they receive |
|---|---|---|
| Arm 2 | Experimental | Not described Receives: Drug: Acetylsalicylic acid (Aspirin, BAYE4465) |
| Arm 3 | Active comparator | Not described Receives: Drug: Paracetamol |
| Arm 4 | Active comparator | Not described Receives: Drug: Paracetamol |
| Arm 5 | Placebo comparator | Not described Receives: Drug: Placebo |
| Arm 1 | Experimental | Not described Receives: Drug: Acetylsalicylic acid (Aspirin, BAYE4465) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose.
Measured: Up to 4 hours post dose
Secondary outcomes (4)
Maximum temperature difference between baseline and the lowest measured temperature
Measured: Up to 4 hours post dose
Time to reach the maximum temperature difference
Measured: Up to 4 hours post dose
Intensity of Upper Respiratory Tract Infection symptoms
Measured: 0, 2, 4, and 6 hours post dose
Safety - assessment of adverse events
Measured: Up to 7 hours post dose
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 completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract InfectionsStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 392 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
- NCT01464944
- Sponsor's protocol ID
- 11202
- Status last verified
- Nov 2011
- First submitted
- 17 May 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Single-dose, Parallel Group, Multicenter Study to Compare the Antipyretic Efficacy of Acetylsalicy-lic Acid 500 mg and 1,000 mg (2 x 500 mg) and Paracetamol 500 mg and 1,000 mg (2 x 500 mg) With Placebo in Patients With Acute Febrile Upper Respiratory Tract Infections Suspected to be of Viral Origin.
- ClinicalTrials.gov ID
- NCT01464944
- Acronym / sponsor ID
- 11202
- Conditions
- Respiratory Tract Infections, Fever
- Keywords
- Upper Respiratory Tract Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Apr 2004 (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.
This study is addressed to patients suffering from an acute febrile upper respiratory tract infection suspected to be of viral origin. The purpose of this study is to determine the antipyretic efficacy (reduction of fever by lowering the body temperature from a raised state) of Aspirin in doses of 500 and 1000 mg (study medication) compared to the one of Paracetamol in doses of 500 and 1000 mg (comparator medication) as well as the one of Placebo (comparator medication without an active substance). Despite of its common use for fever treatment, the scientific data in adults which support the antipyretic efficacy of Aspirin are sparse. Therefore, the purpose of this study is to collect such data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Arm 2 | Experimental | Drug: Acetylsalicylic acid (Aspirin, BAYE4465) |
| Arm 3 | Active comparator | Drug: Paracetamol |
| Arm 4 | Active comparator | Drug: Paracetamol |
| Arm 5 | Placebo comparator | Drug: Placebo |
| Arm 1 | Experimental | Drug: Acetylsalicylic acid (Aspirin, 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)
- Ambulatory male or female patients 18 to 65 years of age
- Acute uncomplicated febrile URTI suspected to be of viral origin and present not more than 5 days
- Symptoms of a viral URTI
- Oral temperature >/= 38.5 °C to </= 40°C
Key exclusion criteria (6 listed)
- Patients with physical findings consistent with the diagnosis of pneumonia, otitis media, bacterial sinusitis or any other bacterial infection of the respiratory tract requiring antibiotics or other therapeutic intervention by a physician
- Current antibiotic treatment or pre-treatment with antibiotic agents during the last week
- History or presence of asthma or hypersensitivity to ASA, salicylates, paracetamol, or other non-steroidal anti-inflammatory drugs; peptic ulceration or gastric bleeding; hemorrhagic diathesis; hepatic and/or renal dysfunction; Gilbert's disease; Quincke's edema
- Any other acute or chronic disease which in the opinion f the investigator could interfere with the patient's health and well-being during the conduct of the study or which could interfere with the evaluation of data generated from this subject
- Any conditions possibly interfering with the gastro-intestinal absorption of the study medication
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)Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol | Drug | Arm 1 |
| Acetylsalicylic acid (Aspirin, BAYE4465)Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Paracetamol | Drug | Arm 2 |
| ParacetamolParacetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid | Drug | Arm 3 |
| ParacetamolParacetamol 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid | Drug | Arm 4 |
| Placebo2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose | Drug | Arm 5 |
Primary outcome
Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose.
Time frame: Up to 4 hours post dose
4 secondary outcomes
Maximum temperature difference between baseline and the lowest measured temperature
Time frame: Up to 4 hours post dose
Time to reach the maximum temperature difference
Time frame: Up to 4 hours post dose
Intensity of Upper Respiratory Tract Infection symptoms
Time frame: 0, 2, 4, and 6 hours post dose
Safety - assessment of adverse events
Time frame: Up to 7 hours post dose
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 8 Nov 2011.
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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
9 sites in 2 countries: 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 Respiratory Tract Infections and Fever, run by Bayer at 9 sites in 2 countries.
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 6 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 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia, Ukraine. 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?
Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose. (time frame: Up to 4 hours post 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 8 Nov 2011.