Common ColdPhase 3NCT01361399

Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold

A Phase 3 study testing Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain, Acetylsalicylic Acid (Aspirin, BAYE4465) and Lidocain in people with Common Cold and Pharyngitis, run by Bayer at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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) & Lidocain, Acetylsalicylic Acid (Aspirin, BAYE4465) and Lidocain
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,088 participants
Where: 19 sitesin 2 countries
Study dates: 30 Nov 2004to 28 May 2005
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

Males and females of at least 18 years of age
Onset of common cold within the last 3 days (12 to 72 hours)
History of at least 4 symptoms associated with URTI in the last 24 hours out of runny nose, stuffy nose, sneezing, wet cough, dry cough, sweating, earache, ear fullness, sinus pressure/pain, head heaviness, muscle aches and pains, feverish discomfort, chills, hoarseness, sore throat, scratchy throat and headache as documented in the history of URTI
Current sore throat confirmed by a score ≥ 6 on a 11-category vertical ordinal scale for sore throat pain
Findings that confirmed the presence of tonsillopharyngitis

Who cannot join

Pregnancy (i.e. positive pregnancy test at baseline)
Breastfeeding
History of hypersensitivity (allergic reaction) to ASA or any other NSAID
History of hypersensitivity (allergic reaction) to lidocaine
History or acute state of peptic ulceration or gastrointestinal bleeding
History of bleeding tendency

Show all 16Show fewer

History of asthma
Clinical diagnosis of chickenpox or influenza
History or presence of severe liver or kidney disease
Intake of short-acting analgesics (e.g. ASA, paracetamol, ibuprofen, diclofenac) either as a single ingredient or as part of a combination cold product in the last 6 hours, or intake of long-acting analgesics (e.g. naproxen) in the last 12 hours, or intake of any other NSAID in the last 24 hours
Use of any local or systemic short-acting cough and cold preparation (e.g. decongestant or antihistaminic drug) in the last 12 hours
Use of any cough or sore throat lozenges/candies or any menthol-containing product (including mentholated tissues) in the last 6 hours
Current intake or requirement of any prescription medication for the current treatment of acute respiratory tract illness
Administration of anticoagulants in the last 7 days
Inability to breathe through the nose or a history of chronic mouth breathing
Presence of any severe concomitant disease or condition which, in the opinion of the investigator, is a reason for exclusion, e.g. serious cardiovascular diseases (in particular arrhythmias), treatment with antiarrhythmics or methotrexate

Trial locations and contacts

19 sites in 2 countries.

Country

City, postcode or hospital

19 sites in 2 countries

Russia13 sites

Study site
Mocow, 117574
Study site
Moscow, 105064
Study site
Moscow, 114765
Study site
Moscow, 117321
Study site
Moscow, 117342
Study site
Moscow, 117393
Study site
Moscow, 117418
Study site
Moscow, 117421
Study site
Moscow, 117485
Study site
Moscow, 117513
Study site
Moscow, 117588
Study site
Moscow, 127299
Study site
Novosibirsk, 630099

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Ukraine6 sites

Study site
Kiev, 02091
Study site
Kiev, 02222
Study site
Kiev, 02232
Study site
Kiev, 03049
Study site
Luhansk, 91011
Study site
Luhansk, 91055

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About this study

Official title: A 4-arm, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Single Dose, Parallel Group Study Comparing Efficacy and Safety of a Fixed Combination of 500 mg Acetylsalicylic Acid + 4 mg Lidocaine With 500 mg Acetylsalicylic Acid and 4 mg Lidocaine Monotherapy as Well as Placebo in Adult Patients With Sore Throat Associated With a Common Cold.

The purpose of this study is to investigate the analgesic efficacy of a single dose of a fixed combination of 500 mg Aspirin (Acetylsalicylic Acid) and 4 mg Lidocaine in adult patients with sore throat associated with a common cold in comparison to a single treatment with 500 mg Aspirin or 4 mg Lidocaine alone as well a Placebo (treatment without any active ingredient). The combination of Aspirin and Lidocaine in a single lozenge is expected to provide relief from sore throat pain by sequential action. A very fast inset of action will be achieved by the locally acting Lidocaine and a long duration of action will be achieved by the systemically acting Aspirin.

Conditions: Common Cold, Pharyngitis, Tonsillitis
Being tested: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain, Acetylsalicylic Acid (Aspirin, BAYE4465), Lidocain, 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) & LidocainDrug
Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)
Acetylsalicylic Acid (Aspirin, BAYE4465)Drug
Single oral application of Aspirin (as lozenge)
LidocainDrug
Single oral application of Lidocain (as lozenge)
PlaceboDrug
Single oral application of Placebo (as lozenge)

Study groups in NCT01361399
Study group	Role	What they receive
Arm 1	Experimental	Not described Receives: Drug: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain
Arm 2	Active comparator	Not described Receives: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Arm 3	Active comparator	Not described Receives: Drug: Lidocain
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.

Sum of pain intensity differences SPID
Measured: 120 minutes
Pain intensity difference to baseline (PID12 min)
Measured: 12 minutes
Pain intensity difference to baseline (PID120 min)
Measured: 120 minutes

Secondary outcomes (5)

Pain intensity difference to baseline (PID)
Measured: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose
Total pain relief to baseline (TOTPAR)
Measured: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose
Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain)
Measured: 60, 120, 180, and 240 minutes post dose
Overall assessment of treatment
Measured: 240 minutes
Assessment of safety and tolerability
Measured: 240 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 200428 May 2005

First posted26 May 2011 (estimated)
Study start30 Nov 2004
Primary completion28 May 2005
Study completion28 May 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,088 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01361399
Sponsor's protocol ID: 11640
Status last verified: Oct 2023
First submitted: 25 May 2011
Last updated: 18 Oct 2023
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Common Cold trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-arm, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled, Single Dose, Parallel Group Study Comparing Efficacy and Safety of a Fixed Combination of 500 mg Acetylsalicylic Acid + 4 mg Lidocaine With 500 mg Acetylsalicylic Acid and 4 mg Lidocaine Monotherapy as Well as Placebo in Adult Patients With Sore Throat Associated With a Common Cold.
ClinicalTrials.gov ID: NCT01361399
Acronym / sponsor ID: 11640
Conditions: Common Cold, Pharyngitis, Tonsillitis
Keywords: Sore Throat
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,088 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Study start: 30 Nov 2004 (actual)
Primary completion: 28 May 2005 (actual)
Study completion: 28 May 2005 (actual)
First posted: 26 May 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.

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, BAYE4465) & Lidocain
Arm 2	Active comparator	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Arm 3	Active comparator	Drug: Lidocain
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 (5 listed)

Males and females of at least 18 years of age
Onset of common cold within the last 3 days (12 to 72 hours)
History of at least 4 symptoms associated with URTI in the last 24 hours out of runny nose, stuffy nose, sneezing, wet cough, dry cough, sweating, earache, ear fullness, sinus pressure/pain, head heaviness, muscle aches and pains, feverish discomfort, chills, hoarseness, sore throat, scratchy throat and headache as documented in the history of URTI
Current sore throat confirmed by a score ≥ 6 on a 11-category vertical ordinal scale for sore throat pain
Findings that confirmed the presence of tonsillopharyngitis

Key exclusion criteria (16 listed)

Pregnancy (i.e. positive pregnancy test at baseline)
Breastfeeding
History of hypersensitivity (allergic reaction) to ASA or any other NSAID
History of hypersensitivity (allergic reaction) to lidocaine
History or acute state of peptic ulceration or gastrointestinal bleeding

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) & LidocainSingle oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)	Drug	Arm 1
Acetylsalicylic Acid (Aspirin, BAYE4465)Single oral application of Aspirin (as lozenge)	Drug	Arm 2
LidocainSingle oral application of Lidocain (as lozenge)	Drug	Arm 3
PlaceboSingle oral application of Placebo (as lozenge)	Drug	Arm 4

Primary outcome

Sum of pain intensity differences SPID
Time frame: 120 minutes
Pain intensity difference to baseline (PID12 min)
Time frame: 12 minutes
Pain intensity difference to baseline (PID120 min)
Time frame: 120 minutes

5 secondary outcomes

Pain intensity difference to baseline (PID)
Time frame: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose
Total pain relief to baseline (TOTPAR)
Time frame: 3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose
Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain)
Time frame: 60, 120, 180, and 240 minutes post dose
Overall assessment of treatment
Time frame: 240 minutes
Assessment of safety and tolerability
Time frame: 240 minutes

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 18 Oct 2023.

Related trials for Common Cold

Recruiting
Effect of Immune X on Common Cold Incidence in Healthy Adults
Common Cold, Upper Respiratory Tract Infection (URTI)
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Recruiting
Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
Respiratory Infections
Recruiting
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"
Acute Rhinitis, Nasal Obstruction

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

Bayer Study Director

Bayer

19 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 16 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 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 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?

Sum of pain intensity differences SPID (time frame: 120 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01361399.

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 18 Oct 2023.