Common ColdPhase 3NCT01158326
Evaluation of Efficacy and Safety of Oral Solution Resfenol in Reducing Symptoms of Common Cold And Flu
A Phase 3 study testing Resfenol in people with Common Cold and Influenza, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the common cold. There will be a randomized, double-blind, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Common Cold, Influenza
- What is being tested?
- Resfenol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Nov 2011
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Men or women older than 12 years and less than or equal to 60 years, without distinction of color and / or race.
- Presenting symptoms of recent onset, for more than 6 hours and less than 48 hours, characterizing one of the following conditions:
- Common cold, which consists of at least 3 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, and these moderate or severe by a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe),
- OR
- Flu-like symptoms consisting of fever of at least 38.1 ° C and headache of moderate or severe 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, a woman of childbearing age.
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- Do not use any other drugs for the treatment of clinical symptoms, except in cases of urgency, and immediate notification to the investigator. Patients with chronic diseases being treated with monotherapy, stable over the last three months, may be included after medical evaluation.
- Good ability of understanding and cooperation.
- Agreement with the informed consent consent (IC).
- Assessment exams, the medical criteria:
- Pregnancy test (rapid urine), a woman of childbearing age, performed prior to inclusion;
- 12-lead electrocardiogram performed during the consultation
- Complete blood count and platelet count, serum creatinine, serum urea, serum sodium, serum potassium, total bilirubin and fractions, gamma-glutamyltransferase, alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), prothrombin time , amylase, blood glucose (if possible in eight hours of fasting), TSH, urinalysis I, chorionic gonadotropin (β-HCG)
Who cannot join
- Pregnant or lactating women
- Known hypersensitivity to components of the formula of the drug solution active
- Use of alcohol or illicit drug use
- Use of monoamine oxidase (MAO) or barbiturates
- Diagnosis of allergic rhinitis or perennial activity
- Presenting the diagnosis of any disease or active acute exacerbated chronic disease (not compensated), including hypertension, ischemic heart disease, narrow-angle glaucoma, symptomatic prostatic hyperplasia, chronic renal failure, liver diseases, infectious tracheobronchitis presumably bacterial pneumonia, streptococcal pharyngitis , 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 (AIDS, hematologic malignancies, use of immunosuppressive drugs and others)
- Patients who received influenza vaccine for the week before 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
- Drug use prior to inclusion by time less than two dose ranges of these drugs (in the case of associations, considered as the reference half-life longer): analgesics, NSAIDs, glucocorticoids and other immunosuppressants, antihistamines, decongestants topical and systemic, as well as any medications that in the opinion of the investigator can modify the results of their study is not due to the drug under investigation or that the interaction place the patient at significant risk
- Having participated in another clinical research for less than a year.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: Evaluation of Efficacy and Safety of Oral Solution Paracetamol, Maleate Chlorpheniramine and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu: a Double-blind
This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the common cold. There will be a randomized, double-blind, placebo-controlled trial. Will be included 216 subjects, male or female, aged greater than 12 and less than or equal to 60 years, irrespective of color and / or race with symptoms of recent onset, for more than 6 hours and less than 48 hours length, characterizing Common Cold and / or Influenza.
After clinical evaluation and laboratory research subjects will be randomized to receive active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. The follow-up visits will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first intervention).
The outcomes to assess the effectiveness so far consist of the scores of symptoms and to assess the safety of the drug will be accompanied by the emergence of adverse events.
Read the detailed description
Infections of upper respiratory tract are common in the population, and its treatment, in most cases involves the use of symptomatic drugs. Paracetamol is used as an analgesic and antipyretic, while chlorpheniramine is an antihistamine and a vasoconstrictor phenylephrine decongestant function. This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the common cold. There will be a randomized, double-blind, placebo-controlled trial. Volunteers will be recruited through posters down at the Hospital de Clinicals de Porto Alegre, and care in the public hospital network, which will undergo a screening questionnaire on first contact. With a statistical power of 80% and the possibility of random error of 5% should be followed in this study 194 subjects. Whereas a loss of up to 10% will be included 216 subjects, male or female, aged greater than 12 and less than or equal to 60 years, irrespective of color and / or race with symptoms of recent onset, for more than 6 hours and less than 48 hours, characterizing one of the following conditions: Common Cold, which consists of at least 3 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, throat discomfort, pain throat, dysphonia, cough, fever, and these moderate or severe using a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe) and / or Influenza consisting fever of at least 38.1 ° C and headache of moderate or severe or myalgia / arthralgia moderate or severe using a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 = moderate , 3 = severe). Will be included only subjects who agree with the Terms of Consent. Not be included in the study pregnant women or infants with known hypersensitivity to components of the formula, or research subjects that are experiencing chronic active or exacerbated. After clinical evaluation and laboratory research subjects will be randomized to receive active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. Be provided paracetamol rescue co-intervention. Study subjects will receive a diary containing questionnaires of symptoms. The follow-up visits will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first intervention). The outcomes to assess the effectiveness so far consist of scores of symptoms, rescue medication use, improvement of fever, subjective evaluation of palatability and tolerance and treatment compliance. To evaluate the safety of the drug will be accompanied by the emergence of adverse events
- Conditions
- Common Cold, Influenza
- Being tested
- Resfenol, Placebo
- Keywords
- reducing symptoms, events, Common Cold, flu syndrome, Symptomatic treatment of the Common Cold and Flu syndrome
- Medical subject headings
- Common Cold, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResfenolDrug
Also called Antigripal
Paracetamol (acetaminophen), chlorpheniramine maleate, phenylephrine hydrochloride.
10 ml of oral solution acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride every 6 hours for 48 hours.
PlaceboOther
Also called Placebo Antigripal
10 ml of oral placebo every 6 hours for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| Resfenol Solution oral | Active comparator | Acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride active drug Receives: Drug: Resfenol |
| Placebo | Placebo comparator | Placebo oral solution Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction global symptom score (0-none, 1-weak, 2-medium, 3-strong)
emergence of adverse events
Measured: 48 hours
Secondary outcomes (1)
Use of rescue medication for relief of symptoms, treatment compliance, improvement of foot
Subjective evaluation of the research subject and the physician
Measured: 48 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 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2011
- Study completionNov 2011
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 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Paulo D Picon, Doctor, Principal investigator, Federal University of Health Science of Porto AlegreLuis Felipe C Schmidt, MD, Study director, Hospital de Clinicas de Porto AlegreMarisa B Costa, MS, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158326
- Sponsor's protocol ID
- 09-542
- Status last verified
- Nov 2011
- First submitted
- 25 Feb 2010
- Last updated
- 28 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
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 Efficacy and Safety of Oral Solution Paracetamol, Maleate Chlorpheniramine and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu: a Double-blind
- ClinicalTrials.gov ID
- NCT01158326
- Acronym / sponsor ID
- 09-542
- Conditions
- Common Cold, Influenza
- Keywords
- reducing symptoms, events, Common Cold, flu syndrome, Symptomatic treatment of the Common Cold and Flu syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 8 Jul 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.
This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the common cold. There will be a randomized, double-blind, placebo-controlled trial. Will be included 216 subjects, male or female, aged greater than 12 and less than or equal to 60 years, irrespective of color and / or race with symptoms of recent onset, for more than 6 hours and less than 48 hours length, characterizing Common Cold and / or Influenza.
After clinical evaluation and laboratory research subjects will be randomized to receive active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. The follow-up visits will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first intervention).
The outcomes to assess the effectiveness so far consist of the scores of symptoms and to assess the safety of the drug will be accompanied by the emergence of adverse events.
Detailed description
Infections of upper respiratory tract are common in the population, and its treatment, in most cases involves the use of symptomatic drugs. Paracetamol is used as an analgesic and antipyretic, while chlorpheniramine is an antihistamine and a vasoconstrictor phenylephrine decongestant function. This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the common cold. There will be a randomized, double-blind, placebo-controlled trial. Volunteers will be recruited through posters down at the Hospital de Clinicals de Porto Alegre, and care in the public hospital network, which will undergo a screening questionnaire on first contact. With a statistical power of 80% and the possibility of random error of 5% should be followed in this study 194 subjects. Whereas a loss of up to 10% will be included 216 subjects, male or female, aged greater than 12 and less than or equal to 60 years, irrespective of color and / or race with symptoms of recent onset, for more than 6 hours and less than 48 hours, characterizing one of the following conditions: Common Cold, which consists of at least 3 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, throat discomfort, pain throat, dysphonia, cough, fever, and these moderate or severe using a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe) and / or Influenza consisting fever of at least 38.1 ° C and headache of moderate or severe or myalgia / arthralgia moderate or severe using a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 = moderate , 3 = severe). Will be included only subjects who agree with the Terms of Consent. Not be included in the study pregnant women or infants with known hypersensitivity to components of the formula, or research subjects that are experiencing chronic active or exacerbated. After clinical evaluation and laboratory research subjects will be randomized to receive active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. Be provided paracetamol rescue co-intervention. Study subjects will receive a diary containing questionnaires of symptoms. The follow-up visits will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first intervention). The outcomes to assess the effectiveness so far consist of scores of symptoms, rescue medication use, improvement of fever, subjective evaluation of palatability and tolerance and treatment compliance. To evaluate the safety of the drug will be accompanied by the emergence of adverse events
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resfenol Solution oral | Active comparator | Drug: ResfenolAcetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride active drug |
| Placebo | Placebo comparator | Other: PlaceboPlacebo oral solution |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Men or women older than 12 years and less than or equal to 60 years, without distinction of color and / or race.
- Presenting symptoms of recent onset, for more than 6 hours and less than 48 hours, characterizing one of the following conditions:
- Common cold, which consists of at least 3 symptoms among the 10 following: sneezing, rhinorrhea, nasal congestion, headache, muscle pain, discomfort in the throat, sore throat, dysphonia, cough, fever, and these moderate or severe by a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe),
- OR
- Flu-like symptoms consisting of fever of at least 38.1 ° C and headache of moderate or severe or myalgia / arthralgia moderate or severe using a scale of severity of symptoms of 4 points (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Key exclusion criteria (12 listed)
- Pregnant or lactating women
- Known hypersensitivity to components of the formula of the drug solution active
- Use of alcohol or illicit drug use
- Use of monoamine oxidase (MAO) or barbiturates
- Diagnosis of allergic rhinitis or perennial 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 |
|---|---|---|
| ResfenolAlso: AntigripalParacetamol (acetaminophen), chlorpheniramine maleate, phenylephrine hydrochloride. 10 ml of oral solution acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride every 6 hours for 48 hours. | Drug | Resfenol Solution oral |
| PlaceboAlso: Placebo Antigripal10 ml of oral placebo every 6 hours for 48 hours | Other | Placebo |
Primary outcome
Reduction global symptom score (0-none, 1-weak, 2-medium, 3-strong)
Time frame: 48 hours
emergence of adverse events
1 secondary outcome
Use of rescue medication for relief of symptoms, treatment compliance, improvement of foot
Time frame: 48 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.
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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 Picon, Doctor principal investigator
Federal University of Health Science of Porto Alegre
Luis Felipe C Schmidt, MD study director
Hospital de Clinicas de Porto Alegre
Marisa B Costa, MS study director
Federal University of Rio Grande do Sul
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 Resfenol in people with Common Cold and Influenza, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 13 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.
Where is the study taking place?
The record lists 1 site in Brazil. 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 global symptom score (0-none, 1-weak, 2-medium, 3-strong) (time frame: 48 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 28 Nov 2011.