Common ColdPhase 3NCT00940836
Efficacy and Safety Assessment of an Anti-Cold Preparation in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome
A Phase 3 study testing Resfenol and Co interventional acetaminophen in people with Common Cold and Flu-like Syndrome, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this study is to assess the efficacy and safety of an anti-cold preparation compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold, Flu-like Syndrome
- What is being tested?
- Resfenol and Co interventional acetaminophen
- 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
- 1 siteBrazil
- Study dates
- Jun 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 to 60 years old;
- Presenting with at least 6 and at max 72 hours of common cold symptoms (headache, muscle ache, rhinorrhea, nasal obstruction, sneezing, cough, sore or irritated throat, hoarseness, fever) or flu-like syndrome (high fever, muscle or articular ache, headache), with at least two symptoms rated by the patient as moderated to severe in an 0 to 4 scale;
- Proper anticonception, in the case of women in fertile age;
- Possibility to abstain from using any other drug for the treatment of the studied condition, except in emergencies, in wich case the responsible party must be immediately notified;
- Cooperation and understanding skills;
- Agreement to informed consent form.
Who cannot join
- Pregnant or lactating women;
- Hypersensitivity to any of the drug's components;
- Alcohol or substance abuse;
- Use of MAO inhibitor or barbituric;
- Diagnosis of any acute disease in current activity or uncontrolled chronic disease;
- Clinical evidence of immunosuppression;
Show all 9Show fewer
- Influenza vaccine less than a week prior to inclusion;
- Need for antibiotic treatment for the respiratory infection, in the opinion of the investigator;
- Having participated in other clinical trial less than one year prior to inclusion.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Paulo D Picon, MD, PhD
Indara C Saccilotto, Administration
About this study
Official title: Phase III Clinical Trial - Efficacy and Safety Assessment of a Compound Acetaminophen, Chlorpheniramine and Phenylephrine Combination in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome in Adults
The aim of this study is to assess the efficacy and safety of an anti-cold preparation compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.
Read the detailed description
Upper respiratory infections are rather frequent in the population, and their treatment consists, in most cases, in the use of symptomatic drugs. Acetaminophen is widely used as an analgesic and antipyretic, whereas chlorpheniramine is an antihistaminic and phenylephrine is a vasoconstrictor with decongestioning activity. The aim of this study is to assess the efficacy and safety of an anti-cold preparation, currently commercialized in Brazil by the name Resfenol, compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.
Healthy volunteers are recruited through panels fixated at Hospital de Clínicas de Porto Alegre, in Brazil, and must answer a screening questionnaire at first contact. One hundred and forty six patients who met the inclusion criteria were included and, after baseline clinical and laboratory evaluation, were randomized to receive either the active intervention or placebo, 5 times a day, at 4 hour intervals, during 48 to 72 hours, depending on patient availability to show up for re-evaluation. Patients also received acetaminophen as a co intervention, to be taken only in case of persisting symptoms.
Patients answered, during treatment, several symptom questionnaires contained in a diary, and followup was performed at days 3 or 4 (clinical and laboratory evaluation) and 10 or 11 (clinical followup). Axillary temperature was assessed along with every dose with a thermometer provided by the study and registered in the diary.
Primary endpoint consists in the mean symptom scores, assessed through questionnaires in patient diary, baseline and followup. Secondary endpoints are global duration of symptoms, time of return to usual activities, use of co intervention for symptom relief, improval of fever and adverse effect evaluation.
- Conditions
- Common Cold, Flu-like Syndrome
- Being tested
- Resfenol, Placebo, Co interventional acetaminophen
- Keywords
- Anti-cold, Cold preparation, RCT
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResfenolDrug
Also called Anti-cold preparation, Acetaminophen, Chlorpheniramine, Phenylephrine
Each capsule of the active drug contains 400mg of acetaminophen, 4mg of chlorpheniramine and 4mg of phenylephrine. Patients will receive up to five capsules a day.
PlaceboDrug
Patients in this group will receive placebo capsules up to five times a day, with the exact same taste and appearance as the active comparator.
Co interventional acetaminophenDrug
Also called Rescue medication, Acetaminophen, Paracetamol, Co intervention
All patients received, along with the assigned intervention, 12 acetaminophen 500mg pills, that they were instructed to take only in case of persisting PAIN or FEVER, up to 4 times a day.
| Study group | Role | What they receive |
|---|---|---|
| Resfenol | Active comparator | Patients in this arm will receive 15 capsules containing a combination described below. They are instructed to take one capsule at 7, 11, 15, 19 and 23h every day, starting after baseline evaluation. The duration of the treatment goes from 48 to 72 hours, depending on patient availability for the second evaluation.
Patients also receive co interventional acetaminophen pills, that they are allowed to take in case of persisting pain or fever, up to 4 times a day. Receives: Drug: Resfenol; Drug: Co interventional acetaminophen |
| Placebo | Placebo comparator | Patients in this arm will receive 15 capsules of placebo, that they are instructed to take in the same posology and in the same duration than the active comparator.
Patients also receive co interventional acetaminophen pills, that they are allowed to take in case of persisting pain or fever, up to 4 times a day. Receives: Drug: Placebo; Drug: Co interventional acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom improval assessed by questionnaires concerning headache, muscle ache, rhinorrhea, nasal obstruction, sneezes, cough, sore or irritated throat, hoarseness and fever, rated by patient himself in a scale from 0 to 4, being 0-absence and 4-severe.
Measured: Questionnaires were answered at baseline and 1st followup to the investigator and during treatment at every dose, 5 times a day, from day 1 to 3/4, through patient's diary.
Secondary outcomes (5)
Global duration of symptoms, assessed by the investigator through direct questioning at followup visits.
Measured: Day 3/4 and, if no relief yet, day 10/11.
Time of return to usual activities, such as work or gym, assessed by the investigator through direct questioning at followup visits.
Measured: Day 3/4 and, if no relief yet, day 10/11.
Use of co intervention for symptom relief during treatment, registered by the volunteer in patient diary, with day and hour of ingestion.
Measured: Assessed during treatment (day 1 to 3/4) by patient diary and questioned by investigator at 1st followup visit.
Improval of fever by reduction of axillary temperature to less than 38,1°C.
Measured: Assessed by investigator at baseline and 1st followup visit and by patient (with termometer provided by the study) along with every dose, 5 times a day, from day 1 to 3/4, registered in patient diary.
Adverse effect appearance during and until 7 days after treatment, assessed through patient's report in the diary or followup visit, through physical evaluation at followup and by laboratory exams.
Measured: Days 1 to 3/4 through patient diary, and followup at days 3/4 an 10/11.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2009 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940836
- Sponsor's protocol ID
- 05492
- Status last verified
- Jul 2009
- First submitted
- 15 Jul 2009
- Last updated
- 16 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trial - Efficacy and Safety Assessment of a Compound Acetaminophen, Chlorpheniramine and Phenylephrine Combination in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome in Adults
- ClinicalTrials.gov ID
- NCT00940836
- Acronym / sponsor ID
- 05492
- Conditions
- Common Cold, Flu-like Syndrome
- Keywords
- Anti-cold, Cold preparation, RCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2009 (estimated)
- First posted
- 16 Jul 2009 (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 assess the efficacy and safety of an anti-cold preparation compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.
Detailed description
Upper respiratory infections are rather frequent in the population, and their treatment consists, in most cases, in the use of symptomatic drugs. Acetaminophen is widely used as an analgesic and antipyretic, whereas chlorpheniramine is an antihistaminic and phenylephrine is a vasoconstrictor with decongestioning activity. The aim of this study is to assess the efficacy and safety of an anti-cold preparation, currently commercialized in Brazil by the name Resfenol, compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.
Healthy volunteers are recruited through panels fixated at Hospital de Clínicas de Porto Alegre, in Brazil, and must answer a screening questionnaire at first contact. One hundred and forty six patients who met the inclusion criteria were included and, after baseline clinical and laboratory evaluation, were randomized to receive either the active intervention or placebo, 5 times a day, at 4 hour intervals, during 48 to 72 hours, depending on patient availability to show up for re-evaluation. Patients also received acetaminophen as a co intervention, to be taken only in case of persisting symptoms.
Patients answered, during treatment, several symptom questionnaires contained in a diary, and followup was performed at days 3 or 4 (clinical and laboratory evaluation) and 10 or 11 (clinical followup). Axillary temperature was assessed along with every dose with a thermometer provided by the study and registered in the diary.
Primary endpoint consists in the mean symptom scores, assessed through questionnaires in patient diary, baseline and followup. Secondary endpoints are global duration of symptoms, time of return to usual activities, use of co intervention for symptom relief, improval of fever and adverse effect evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resfenol | Active comparator | Drug: Resfenol, Drug: Co interventional acetaminophenPatients in this arm will receive 15 capsules containing a combination described below. They are instructed to take one capsule at 7, 11, 15, 19 and 23h every day, starting after baseline evaluation. The duration of the treatment goes from 48 to 72 hours, depending on patient availability for the second evaluation. Patients also receive co interventional acetaminophen pills, that they are allowed to take in case of persisting pain or fever, up to 4 times a day. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Co interventional acetaminophenPatients in this arm will receive 15 capsules of placebo, that they are instructed to take in the same posology and in the same duration than the active comparator. Patients also receive co interventional acetaminophen pills, that they are allowed to take in case of persisting pain or fever, up to 4 times a day. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 to 60 years old;
- Presenting with at least 6 and at max 72 hours of common cold symptoms (headache, muscle ache, rhinorrhea, nasal obstruction, sneezing, cough, sore or irritated throat, hoarseness, fever) or flu-like syndrome (high fever, muscle or articular ache, headache), with at least two symptoms rated by the patient as moderated to severe in an 0 to 4 scale;
- Proper anticonception, in the case of women in fertile age;
- Possibility to abstain from using any other drug for the treatment of the studied condition, except in emergencies, in wich case the responsible party must be immediately notified;
- Cooperation and understanding skills;
Key exclusion criteria (9 listed)
- Pregnant or lactating women;
- Hypersensitivity to any of the drug's components;
- Alcohol or substance abuse;
- Use of MAO inhibitor or barbituric;
- Diagnosis of any acute disease in current activity or uncontrolled chronic disease;
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: Anti-cold preparation, Acetaminophen, Chlorpheniramine, PhenylephrineEach capsule of the active drug contains 400mg of acetaminophen, 4mg of chlorpheniramine and 4mg of phenylephrine. Patients will receive up to five capsules a day. | Drug | Resfenol |
| PlaceboPatients in this group will receive placebo capsules up to five times a day, with the exact same taste and appearance as the active comparator. | Drug | Placebo |
| Co interventional acetaminophenAlso: Rescue medication, Acetaminophen, Paracetamol, Co interventionAll patients received, along with the assigned intervention, 12 acetaminophen 500mg pills, that they were instructed to take only in case of persisting PAIN or FEVER, up to 4 times a day. | Drug | Placebo, Resfenol |
Primary outcome
Symptom improval assessed by questionnaires concerning headache, muscle ache, rhinorrhea, nasal obstruction, sneezes, cough, sore or irritated throat, hoarseness and fever, rated by patient himself in a scale from 0 to 4, being 0-absence and 4-severe.
Time frame: Questionnaires were answered at baseline and 1st followup to the investigator and during treatment at every dose, 5 times a day, from day 1 to 3/4, through patient's diary.
5 secondary outcomes
Global duration of symptoms, assessed by the investigator through direct questioning at followup visits.
Time frame: Day 3/4 and, if no relief yet, day 10/11.
Time of return to usual activities, such as work or gym, assessed by the investigator through direct questioning at followup visits.
Time frame: Day 3/4 and, if no relief yet, day 10/11.
Use of co intervention for symptom relief during treatment, registered by the volunteer in patient diary, with day and hour of ingestion.
Time frame: Assessed during treatment (day 1 to 3/4) by patient diary and questioned by investigator at 1st followup visit.
Improval of fever by reduction of axillary temperature to less than 38,1°C.
Time frame: Assessed by investigator at baseline and 1st followup visit and by patient (with termometer provided by the study) along with every dose, 5 times a day, from day 1 to 3/4, registered in patient diary.
Adverse effect appearance during and until 7 days after treatment, assessed through patient's report in the diary or followup visit, through physical evaluation at followup and by laboratory exams.
Time frame: Days 1 to 3/4 through patient diary, and followup at days 3/4 an 10/11.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2009.
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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.
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 and Co interventional acetaminophen in people with Common Cold and Flu-like Syndrome, 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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 16 Jul 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paulo D Picon, MD, PhD (55 xx 51 33598752, paulopicon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom improval assessed by questionnaires concerning headache, muscle ache, rhinorrhea, nasal obstruction, sneezes, cough, sore or irritated throat, hoarseness and fever, rated by patient himself in a scale from 0 to 4, being 0-absence and 4-severe. (time frame: Questionnaires were answered at baseline and 1st followup to the investigator and during treatment at every dose, 5 times a day, from day 1 to 3/4, through patient's diary.). 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 16 Jul 2009.