ColdPhase 3NCT02735070
Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold
A Phase 3 study testing Resfenol and Coristina d in people with Cold, run by Brainfarma Industria Química e Farmacêutica S/A.
Trial summary
The primary objective of this study is to evaluate the non-inferiority of Coristina® d in the symptomatic treatment of the common cold compared to Resfenol® comparator. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cold
- What is being tested?
- Resfenol and Coristina d
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Mar 2017
- 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
- Sign and date the informed consent form;
- Age between 18 and 60 years old;
- Symptoms of common cold not exceeding 72 hours must be present;
- It will be considered symptoms of the common cold the presence of at least 2 of the 10 symptoms following: runny nose, sneezing, nasal congestion, headache, myalgia, throat discomfort or sore throat, hoarseness, cough or fever. Each of the symptoms listed above will receive a score by Likert scale (no symptom = 0, mild symptoms = 1, moderate symptoms = 2, intense symptoms = 3). The minimum total is 0 and maximum one is 30, which included patients with score higher or equal to 4 points.
Who cannot join
- Presence of suggestive symptoms or prior diagnosis requiring regular and continuous treatment of allergic rhinitis or asthma in the last 2 years;
- Chronic disease of any kind that is contraindicate the participation of the patient based on the opinion of investigator;
- Hypersensitivity or contraindication to use of components of the study medications;
- Pregnant or women of childbearing age without adequate contraception;
- Use of other anti-influenza drugs programmed during the study or for the last 5 days;
- Regular active smokers (more than 3 cigarettes a day);
- Participation in another clinical study in less than one year (unless justified benefit by the investigator).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase III Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold
The primary objective of this study is to evaluate the non-inferiority of Coristina® d in the symptomatic treatment of the common cold compared to Resfenol® comparator.
Read the detailed description
Eligible patients must sign the informed consent form and they will be between 18 and 60 years old and common cold symptoms for no more than 72 hours.
It will be recruited for this study 366 patients, 183 patients per group. It is estimated that the total number of patients can be recruited in 4 to 6 months from the regulatory approval of the study.
The patient will stay in the study approximately 7 to 10 days (including screening visit / randomization, telephone contact in 3 to 5 days after randomization and final visit from 1 to 3 days after last dose).
Study medication (Coristina d and Resfenol) will be provided by the sponsor and will be appropriately labeled for the clinical study, containing the sponsor information, the trial identification, expiration date, batch and storage conditions
- Conditions
- Cold
- Being tested
- Resfenol, Coristina d
- Keywords
- Common cold treatment
- 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
Patients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes.
Coristina dDrug
Patients included in the study will take the drugs 4 times a day, orally. Patients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Corisitina D | Experimental | The patient will use the medication 4 times a day - orally The tablets of Coristina® d contain 400 mg acetylsalicylic acid, dexchlorpheniramine 1 mg, 10 mg phenylephrine, and 30 mg of caffeine. Coristina® d is indicated as an analgesic, antipyretic, antiallergic, and nasal congestion for the treatment of the symptoms of influenza and common cold. Receives: Drug: Coristina d |
| Resfenol | Active comparator | The patient will use the medication 4x / day - orally Resfenol® drug acts against the symptoms of colds and flu, such as nasal congestion, runny nose, fever, headache, muscle pain and other symptoms. The capsules containing 400mg of paracetamol, 4 mg chlorpheniramine and 4mg phenylephrine. Receives: Drug: Resfenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Evaluation from 1 to 3 days after last dose
The primary outcome will be the global evaluation from investigator to be done from 1 to 3 days after the last dose.
Measured: From 1 to 3 days after the last dose
Secondary outcomes (4)
Likert Scale for symptons
It will be used a Likert Scale to evaluate the intensity of cold symptoms. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.
Measured: From the screening until 1 to 3 days after the last dose
Sleep Questionnaire
It will be used a Sleep questionnaire to evaluate the sleep quality. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.
Measured: From the screening until 1 to 3 days after the last dose
Daily Activities
It will be used a daily activities questionnaire to evaluate the physical and mental disposition on the routine daily activities. It will be used at screening, between 3-5 days of randomization and between 1 to 3 days after the last dose.
Measured: From the screening until 1 to 3 days after the last dose
Adverse Events
It will be evaluated and monitored the adverse events in order to assess the patient safety. It will be evaluated from randomization up to 1-3 days after last dose.
Measured: From the randomization until 1 to 3 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for ColdStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Techtrials Pesquisa e Tecnologia Ltda, Pharmagenix
- Responsible party
- Sponsor
- Investigators
- Márcio Antônio Pereira, Dr., Principal investigator, MAP Clínica de Endocrinologia LtdaAmanda Faulhaber, Dr., Principal investigator, Pesquisare Saude S/S LtdaClóvis Eduardo S Galvão, Dr., Principal investigator, Instituto de Pesquisa Clínica e Medicina Avançada - IMAAntônio Carlos da Silva, Dr., Principal investigator, ClinilivePaula YU Tokunaga, Dr., Principal investigator, Centro de Estudos Clínicos do Interior Paulista - CECIPCarlos I Filho, Dr., Principal investigator, Unidade de Pesquisa Clínica do Centro de Medicina Reprodutiva Dr.Carlos Isaia Filho Ltda.Durval C Kraychete, Dr., Principal investigator, CTD Dor Clinica de Diagnostico e Terapia da Dor LtdaLívia FA Oliveira, Dr., Principal investigator, Universidade Federal do Triângulo Mineiro - Núcleo de Estudos Clínicos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735070
- Sponsor's protocol ID
- Coristina® d
- Status last verified
- Apr 2016
- First submitted
- 18 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data that will be collected are: demographics data; medical history, disease characteristics; Likert scale; physician and patient perception about the study treatment; Sleep Questionnaire; evaluation for daily activities willingness; Safety Assessments; Vital Signs and Physical Examination; additional tests; Adverse Events. All data collected for the study will be recorded, stored and retrieved through electronic case report form designed specifically for this study. All information will be inserted in a database. All data collected for the study will be analyzed centrally by independent scientific consulting company designated for this purpose. The publication of the overall results of the study will be coordinated by the sponsor. The responsibility for the content of the publications will be shared between the sponsor and co-authors, who will participate in the review of the content and give consent for publication.
Publications
De Sutter AI, van Driel ML, Kumar AA, Lesslar O, Skrt A. Oral antihistamine-decongestant-analgesic combinations for the common cold. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD004976. doi: 10.1002/14651858.CD004976.pub3.
PubMed 22336807Allan GM, Arroll B. Prevention and treatment of the common cold: making sense of the evidence. CMAJ. 2014 Feb 18;186(3):190-9. doi: 10.1503/cmaj.121442. Epub 2014 Jan 27. No abstract available.
PubMed 24468694Picon 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 24261438Mizoguchi H, Wilson A, Jerdack GR, Hull JD, Goodale M, Grender JM, Tyler BA. Efficacy of a single evening dose of syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple common cold symptoms. Int J Clin Pharmacol Ther. 2007 Apr;45(4):230-6. doi: 10.5414/cpp45230.
PubMed 17474541Common Cold Collaborative Group; Robert M, Llorens M, Garcia E, Luria X. Efficacy and tolerability of ebastine 10 mg plus pseudoephedrine 120 mg in the symptomatic relief of the common cold. Eur J Intern Med. 2004 Jul;15(4):242-247. doi: 10.1016/j.ejim.2004.03.009.
PubMed 15288679Bula Coristina d (Nov 2012, atualizada em 2014).
Micromedex novembro de 2015: ácido acetilsalicílico Micromedex novembro de 2015: dexclorfeniramina
Bantz EW, Dolen WK, Chadwick EW, Nelson HS. Chronic chlorpheniramine therapy: subsensitivity, drug metabolism, and compliance. Ann Allergy. 1987 Nov;59(5):341-6.
PubMed 3688558Munch EP, Soborg M, Norreslet TT, Mygind N. A comparative study of dexchlorpheniramine maleate sustained release tablets and budesonide nasal spray in seasonal allergic rhinitis. Allergy. 1983 Oct;38(7):517-24. doi: 10.1111/j.1398-9995.1983.tb02361.x.
PubMed 6139040Pastorello EA, Ortolani C, Gerosa S, Pravettoni V, Codecasa LR, Fugazza A, Zanussi C. Antihistaminic treatment of allergic rhinitis: a double-blind study with terfenadine versus dexchlorpheniramine. Pharmatherapeutica. 1987;5(2):69-75.
PubMed 2889217Product Information: Polaramine(R), dexchlorpheniramine maleate. Schering Corporation, Kenilworth, NJ, 1990.
Simons FE, Simons KJ, Chung M, Yeh J. The comparative pharmacokinetics of H1-receptor antagonists. Ann Allergy. 1987 Dec;59(6 Pt 2):20-4.
PubMed 2892445Micromedex novembro de 2015: fenilefrina
Hatton RC, Winterstein AG, McKelvey RP, Shuster J, Hendeles L. Efficacy and safety of oral phenylephrine: systematic review and meta-analysis. Ann Pharmacother. 2007 Mar;41(3):381-90. doi: 10.1345/aph.1H679. Epub 2007 Jan 30.
PubMed 17264159Hengstmann JH, Goronzy J. Pharmacokinetics of 3H-phenylephrine in man. Eur J Clin Pharmacol. 1982;21(4):335-41. doi: 10.1007/BF00637623.
PubMed 7056280
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold
- ClinicalTrials.gov ID
- NCT02735070
- Acronym / sponsor ID
- Coristina® d
- Conditions
- Cold
- Keywords
- Common cold treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/AIndustry (pharma, biotech, devices)
- Collaborators
- Techtrials Pesquisa e Tecnologia Ltda, Pharmagenix
- Study start
- Sep 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 12 Apr 2016 (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 primary objective of this study is to evaluate the non-inferiority of Coristina® d in the symptomatic treatment of the common cold compared to Resfenol® comparator.
Detailed description
Eligible patients must sign the informed consent form and they will be between 18 and 60 years old and common cold symptoms for no more than 72 hours.
It will be recruited for this study 366 patients, 183 patients per group. It is estimated that the total number of patients can be recruited in 4 to 6 months from the regulatory approval of the study.
The patient will stay in the study approximately 7 to 10 days (including screening visit / randomization, telephone contact in 3 to 5 days after randomization and final visit from 1 to 3 days after last dose).
Study medication (Coristina d and Resfenol) will be provided by the sponsor and will be appropriately labeled for the clinical study, containing the sponsor information, the trial identification, expiration date, batch and storage conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corisitina D | Experimental | Drug: Coristina dThe patient will use the medication 4 times a day - orally The tablets of Coristina® d contain 400 mg acetylsalicylic acid, dexchlorpheniramine 1 mg, 10 mg phenylephrine, and 30 mg of caffeine. Coristina® d is indicated as an analgesic, antipyretic, antiallergic, and nasal congestion for the treatment of the symptoms of influenza and common cold. |
| Resfenol | Active comparator | Drug: ResfenolThe patient will use the medication 4x / day - orally Resfenol® drug acts against the symptoms of colds and flu, such as nasal congestion, runny nose, fever, headache, muscle pain and other symptoms. The capsules containing 400mg of paracetamol, 4 mg chlorpheniramine and 4mg phenylephrine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sign and date the informed consent form;
- Age between 18 and 60 years old;
- Symptoms of common cold not exceeding 72 hours must be present;
- It will be considered symptoms of the common cold the presence of at least 2 of the 10 symptoms following: runny nose, sneezing, nasal congestion, headache, myalgia, throat discomfort or sore throat, hoarseness, cough or fever. Each of the symptoms listed above will receive a score by Likert scale (no symptom = 0, mild symptoms = 1, moderate symptoms = 2, intense symptoms = 3). The minimum total is 0 and maximum one is 30, which included patients with score higher or equal to 4 points.
Key exclusion criteria (7 listed)
- Presence of suggestive symptoms or prior diagnosis requiring regular and continuous treatment of allergic rhinitis or asthma in the last 2 years;
- Chronic disease of any kind that is contraindicate the participation of the patient based on the opinion of investigator;
- Hypersensitivity or contraindication to use of components of the study medications;
- Pregnant or women of childbearing age without adequate contraception;
- Use of other anti-influenza drugs programmed during the study or for the last 5 days;
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 |
|---|---|---|
| ResfenolPatients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes. | Drug | Resfenol |
| Coristina dPatients included in the study will take the drugs 4 times a day, orally. Patients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes. | Drug | Corisitina D |
Primary outcome
Global Evaluation from 1 to 3 days after last dose
Time frame: From 1 to 3 days after the last dose
The primary outcome will be the global evaluation from investigator to be done from 1 to 3 days after the last dose.
4 secondary outcomes
Likert Scale for symptons
Time frame: From the screening until 1 to 3 days after the last dose
Sleep Questionnaire
Time frame: From the screening until 1 to 3 days after the last dose
Daily Activities
Time frame: From the screening until 1 to 3 days after the last dose
Adverse Events
Time frame: From the randomization until 1 to 3 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Results publication: PubMed 22336807De Sutter AI, van Driel ML, Kumar AA, Lesslar O, Skrt A. Oral antihistamine-decongestant-analgesic combinations for the common cold. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD004976. doi: 10.1002/14651858.CD004976.pub3.
- Results publication: PubMed 24468694Allan GM, Arroll B. Prevention and treatment of the common cold: making sense of the evidence. CMAJ. 2014 Feb 18;186(3):190-9. doi: 10.1503/cmaj.121442. Epub 2014 Jan 27. No abstract available.
- Results publication: 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.
- Results publication: PubMed 17474541Mizoguchi H, Wilson A, Jerdack GR, Hull JD, Goodale M, Grender JM, Tyler BA. Efficacy of a single evening dose of syrup containing paracetamol, dextromethorphan hydrobromide, doxylamine succinate and ephedrine sulfate in subjects with multiple common cold symptoms. Int J Clin Pharmacol Ther. 2007 Apr;45(4):230-6. doi: 10.5414/cpp45230.
- Results publication: PubMed 15288679Common Cold Collaborative Group; Robert M, Llorens M, Garcia E, Luria X. Efficacy and tolerability of ebastine 10 mg plus pseudoephedrine 120 mg in the symptomatic relief of the common cold. Eur J Intern Med. 2004 Jul;15(4):242-247. doi: 10.1016/j.ejim.2004.03.009.
- Results publicationBula Coristina d (Nov 2012, atualizada em 2014).
- Results publicationMicromedex novembro de 2015: ácido acetilsalicílico Micromedex novembro de 2015: dexclorfeniramina
- Results publication: PubMed 3688558Bantz EW, Dolen WK, Chadwick EW, Nelson HS. Chronic chlorpheniramine therapy: subsensitivity, drug metabolism, and compliance. Ann Allergy. 1987 Nov;59(5):341-6.
- Results publication: PubMed 6139040Munch EP, Soborg M, Norreslet TT, Mygind N. A comparative study of dexchlorpheniramine maleate sustained release tablets and budesonide nasal spray in seasonal allergic rhinitis. Allergy. 1983 Oct;38(7):517-24. doi: 10.1111/j.1398-9995.1983.tb02361.x.
- Results publication: PubMed 2889217Pastorello EA, Ortolani C, Gerosa S, Pravettoni V, Codecasa LR, Fugazza A, Zanussi C. Antihistaminic treatment of allergic rhinitis: a double-blind study with terfenadine versus dexchlorpheniramine. Pharmatherapeutica. 1987;5(2):69-75.
- Results publicationProduct Information: Polaramine(R), dexchlorpheniramine maleate. Schering Corporation, Kenilworth, NJ, 1990.
- Results publication: PubMed 2892445Simons FE, Simons KJ, Chung M, Yeh J. The comparative pharmacokinetics of H1-receptor antagonists. Ann Allergy. 1987 Dec;59(6 Pt 2):20-4.
- Individual participant dataSharing planned: Yes. The data that will be collected are: demographics data; medical history, disease characteristics; Likert scale; physician and patient perception about the study treatment; Sleep Questionnaire; evaluation for daily activities willingness; Safety Assessments; Vital Signs and Physical Examination; additional tests; Adverse Events. All data collected for the study will be recorded, stored and retrieved through electronic case report form designed specifically for this study. All information will be inserted in a database. All data collected for the study will be analyzed centrally by independent scientific consulting company designated for this purpose. The publication of the overall results of the study will be coordinated by the sponsor. The responsibility for the content of the publications will be shared between the sponsor and co-authors, who will participate in the review of the content and give consent for publication.
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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.
Márcio Antônio Pereira, Dr. principal investigator
MAP Clínica de Endocrinologia Ltda
Amanda Faulhaber, Dr. principal investigator
Pesquisare Saude S/S Ltda
Clóvis Eduardo S Galvão, Dr. principal investigator
Instituto de Pesquisa Clínica e Medicina Avançada - IMA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Resfenol and Coristina d in people with Cold, run by Brainfarma Industria Química e Farmacêutica S/A.
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 7 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 12 Apr 2016. 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. 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 Rosária Vastella (551130339742, rosariavastella@ttrial.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Evaluation from 1 to 3 days after last dose (time frame: From 1 to 3 days after the last dose). 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 NCT02735070, which also lists 24 linked publications.
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 12 Apr 2016.