FluPhase 3NCT01389518
Efficacy and Safety of Paracetamol, Chlorpheniramine and Phenylephrine in the Treatment of Common Cold and Flu Syndrome
A Phase 3 study testing Active in people with Flu, run by Hospital de Clinicas de Porto Alegre.
Trial summary
The aim of this study is to evaluate the efficacy and safety of a fixed combination of paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and flu-like illness in adults in a randomized, double-blind, controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Flu
- What is being tested?
- Active
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Nov 2009
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women between 18 and 60;
- Presented symptoms of recent onset, for more than 6 hours and less than 72 hours, characterizing one of the following conditions:
- the common cold, which consists of at least 2 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, the latter being of moderate to severe intensity through a symptom severity scale of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe).
- the flu syndrome, which consists of fever of at least 38.1 ° C and headache of moderate or severe intensity or myalgia / arthralgia moderate or severe using a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe).
- Adequate contraception if women of childbearing age.
- Ability to not use any other drugs for the treatment of clinical symptoms, except in cases of urgency, and immediate communication with the investigator, patients with chronic diseases being treated with monotherapy, stable over the past three months, could be included.
- Good understanding capacity and collaboration.
- Compliance with the informed consent form had been signed.
Who cannot join
- Pregnant women or nursing mothers
- Known hypersensitivity to components of the formula of anti-flu drug
- Use of alcohol or illicit drug use
- Use of monoamine oxidase inhibitors or barbiturates
- Diagnosis of seasonal or perennial allergic rhinitis in activity
- Presenting the diagnosis of any disease activity in acute or chronic disease exacerbated (uncompensated), including hypertension, ischemic heart disease, narrow-angle glaucoma, symptomatic prostatic hyperplasia, chronic renal failure, liver diseases, infectious tracheobronchitis presumably bacterial pneumonia, pharyngitis strep, asthma or chronic obstructive pulmonary disease and any disease or condition that in the opinion of the investigator can modify the results of their study is not due to the drug under investigation or that puts the patient at significant risk;
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- Clinical evidence of immunosuppression;
- Patients who received influenza vaccine for the week prior to inclusion
- Patients who in the opinion of the attending physician and / or the investigator may need to receive antiviral drugs for treatment of infection with influenza virus A or B (eg, amantadine, rimantadine, oseltamivir, zanamivir)
- Patients who in the opinion of the attending physician and / or the investigator need receive antibacterial drugs for the treatment of acute respiratory infection
- Use of drugs prior to inclusion by time intervals of less than two doses of these drugs (in the case of associations, considered as the reference half-life longer): analgesics, nonsteroidal anti-inflammatory drugs, glucocorticoids and other immunosuppressants, antihistamines, Topical and systemic decongestants, and any medication that in the opinion of the investigator can modify the results of their study is not due to the drug under investigation or by an interaction that place the patient at significant risk
- Participation in another clinical research for less than a year.
About this study
Official title: Evaluation of the Efficacy and Safety of Fixed Combination of Paracetamol, Chlorpheniramine and Phenylephrine in the Treatment of Symptomatic Common Cold and Flu Syndrome in Adults
The aim of this study is to evaluate the efficacy and safety of a fixed combination of paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and flu-like illness in adults in a randomized, double-blind, controlled trial. The investigators included 146 healthy study subjects aged between 18 and 60 years who presented flu or common cold moderate to severe onset of less than 3 days (72 hours). After clinical and laboratory evaluation were randomized to receive active drug or placebo, five capsules a day, every 4 hours for 48-72h.The outcomes to assess the effectiveness involve the measurement of symptom scores, overall duration of symptoms, return to usual activities, use of rescue medication, improvement of the fever.
Read the detailed description
The upper respiratory infections are frequent in the population, and its treatment, in most cases involves the use of symptomatic drugs. Paracetamol is used as an analgesic and antipyretic, whereas chlorpheniramine and phenylephrine is an antihistamine with a vasoconstrictor decongestant function. The aim of this study is to evaluate the efficacy and safety of a fixed combination of paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and flu-like illness in adults in a randomized, double-blind, controlled trial.
- Conditions
- Flu
- Being tested
- Active, Placebo
- Keywords
- Symptomatic treatment, Common Cold, flu syndrome
- Medical subject headings
- Influenza, Human, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveDrug
Also called Active Flu
1 capsule de active (fixed combination of acetaminophen, chlorpheniramine and phenylephrine) administered in four 4-hour period of wakefulness in between at 07:00 and 23:00 (five daily doses) for two or three consecutive days
PlaceboDrug
Also called Placebo Comparator Flu
1 capsule administered in four 4-hour period of wakefulness in between at 07:00 and 23:00 (five daily doses) for two or three consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol,Chlorpheniramin,Phenylephrin | Active comparator | Not described Receives: Drug: Active |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom score
We assessed symptoms of common cold or flu-like illness with symptoms of global scale for assessing efficacy in clinical trial. The scale consists of 10 symptoms (sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough and fever). We used a Likert scale of intensity of 4 points where 0 no symptoms, 1 mild symptom, 2 moderate symptom, 3 severe symptom intensity.Overall duration of symptoms. Return to normal activity. Use of rescue medication for relief of symptoms. Improves fever by reducing the axillary temperature below 38.1 ° C
Measured: 72 hours
Secondary outcomes (1)
Adverse events
The safety of the product will be accompanied by subjective report of patients, the emergence of adverse effects such as drowsiness, nausea, eye pain, dizziness and palpitations. In addition, there will be accompanied by clinical laboratory parameters.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startMay 2009
- Primary completionJul 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FluStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Paulo D Piccon, Prof. Dr., Principal investigator, Federal University of Rio Grande do Sul (UFRGS) / Hospital de Clinicas de Porto AlegreMarisa B Costa, MS, Study director, Federal University of Rio Grande do SulLuis Felipe C Schmidt, MD, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389518
- Sponsor's protocol ID
- 05-492
- Status last verified
- Nov 2011
- First submitted
- 15 Feb 2011
- Last updated
- 28 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Picon PD, Costa MB, da Veiga Picon R, Fendt LC, Suksteris ML, Saccilotto IC, Dornelles AD, Schmidt LF. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial. BMC Infect Dis. 2013 Nov 22;13:556. doi: 10.1186/1471-2334-13-556.
PubMed 24261438
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Fixed Combination of Paracetamol, Chlorpheniramine and Phenylephrine in the Treatment of Symptomatic Common Cold and Flu Syndrome in Adults
- ClinicalTrials.gov ID
- NCT01389518
- Acronym / sponsor ID
- 05-492
- Conditions
- Flu
- Keywords
- Symptomatic treatment, Common Cold, flu syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 8 Jul 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 aim of this study is to evaluate the efficacy and safety of a fixed combination of paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and flu-like illness in adults in a randomized, double-blind, controlled trial. The investigators included 146 healthy study subjects aged between 18 and 60 years who presented flu or common cold moderate to severe onset of less than 3 days (72 hours). After clinical and laboratory evaluation were randomized to receive active drug or placebo, five capsules a day, every 4 hours for 48-72h.The outcomes to assess the effectiveness involve the measurement of symptom scores, overall duration of symptoms, return to usual activities, use of rescue medication, improvement of the fever.
Detailed description
The upper respiratory infections are frequent in the population, and its treatment, in most cases involves the use of symptomatic drugs. Paracetamol is used as an analgesic and antipyretic, whereas chlorpheniramine and phenylephrine is an antihistamine with a vasoconstrictor decongestant function. The aim of this study is to evaluate the efficacy and safety of a fixed combination of paracetamol, phenylephrine and chlorpheniramine in symptomatic treatment of common cold and flu-like illness in adults in a randomized, double-blind, controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol,Chlorpheniramin,Phenylephrin | Active comparator | Drug: Active |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women between 18 and 60;
- Presented symptoms of recent onset, for more than 6 hours and less than 72 hours, characterizing one of the following conditions:
- the common cold, which consists of at least 2 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, the latter being of moderate to severe intensity through a symptom severity scale of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe).
- the flu syndrome, which consists of fever of at least 38.1 ° C and headache of moderate or severe intensity or myalgia / arthralgia moderate or severe using a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe).
- Adequate contraception if women of childbearing age.
Key exclusion criteria (12 listed)
- Pregnant women or nursing mothers
- Known hypersensitivity to components of the formula of anti-flu drug
- Use of alcohol or illicit drug use
- Use of monoamine oxidase inhibitors or barbiturates
- Diagnosis of seasonal or perennial allergic rhinitis in activity
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 |
|---|---|---|
| ActiveAlso: Active Flu1 capsule de active (fixed combination of acetaminophen, chlorpheniramine and phenylephrine) administered in four 4-hour period of wakefulness in between at 07:00 and 23:00 (five daily doses) for two or three consecutive days | Drug | Paracetamol,Chlorpheniramin,Phenylephrin |
| PlaceboAlso: Placebo Comparator Flu1 capsule administered in four 4-hour period of wakefulness in between at 07:00 and 23:00 (five daily doses) for two or three consecutive days | Drug | Placebo |
Primary outcome
Symptom score
Time frame: 72 hours
We assessed symptoms of common cold or flu-like illness with symptoms of global scale for assessing efficacy in clinical trial. The scale consists of 10 symptoms (sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough and fever). We used a Likert scale of intensity of 4 points where 0 no symptoms, 1 mild symptom, 2 moderate symptom, 3 severe symptom intensity.Overall duration of symptoms. Return to normal activity. Use of rescue medication for relief of symptoms. Improves fever by reducing the axillary temperature below 38.1 ° C
1 secondary outcome
Adverse events
Time frame: 72 hours
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 28 Nov 2011.
- Derived from this study: PubMed 24261438Picon PD, Costa MB, da Veiga Picon R, Fendt LC, Suksteris ML, Saccilotto IC, Dornelles AD, Schmidt LF. Symptomatic treatment of the common cold with a fixed-dose combination of paracetamol, chlorphenamine and phenylephrine: a randomized, placebo-controlled trial. BMC Infect Dis. 2013 Nov 22;13:556. doi: 10.1186/1471-2334-13-556.
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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.
Paulo D Piccon, Prof. Dr. principal investigator
Federal University of Rio Grande do Sul (UFRGS) / Hospital de Clinicas de Porto Alegre
Marisa B Costa, MS study director
Federal University of Rio Grande do Sul
Luis Felipe C Schmidt, MD study director
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Active in people with Flu, run by Hospital de Clinicas de Porto Alegre.
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 8 inclusion and 12 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 28 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Symptom score (time frame: 72 hours). 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 NCT01389518, which also lists 1 linked publication.
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 28 Nov 2011.