ColdPhase 3NCT02904304
Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu
A Phase 3 study testing Desloratadine+Phenylephrine+Ibuprofen in people with Cold, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.
Trial summary
National clinical trial, phase III, multicenter, randomized, prospective, double-blind, parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged equal or more than 18 years will be randomly allocated to one the drug group or placebo group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cold
- What is being tested?
- Desloratadine+Phenylephrine+Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2020to Sep 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older or equal to 18 and younger than 66 years;
- Subjects diagnosed with common cold / flu syndrome defined by clinical evaluation and the presence of two or more of the following symptoms: sneezing, rhinorrhea, nasal obstruction, headache, throat discomfort, sore throat, dysphonia, myalgia, cough and fever classified as moderate or intense in four intensity scale (04) items (0 = absent, 01 = light, 02 = moderate, 03 = severe);
- Beginning of the symptoms of common cold / flu-like syndrome in a minimum period of 24 hours and a maximum of 72 hours prior to V0;
- Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF);
Who cannot join
- Any laboratorial finding (clinical evaluation / physical evaluation / vital signs / ECG changes) that the Investigator consider a risk to subject of the study;
- Hypersensitivity to the drug components used during the study;
- Women in pregnancy or nursing period;
- Women in reproductive age who do not agree to use contraception acceptable [oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation]; other than surgically sterile (bilateral oophorectomy or hysterectomy), postmenopausal for at least one (01) years or sexual abstinence;
- Subjects that has participated in clinical trial protocols in the last twelve (12) months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;
- Alcohol abuse that, according to the investigator, may interfere with the pharmacological adherence to the clinical protocol;
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- Any medical conditions which may interfere with efficacy and / or safety of the treatment with the investigational product, such as but not limited to disorders described below:
- Untreated or uncontrolled Hyperthyroidism
- Uncontrolled epilepsy
- diagnosis of glaucoma
- Moderate or severe persistent asthma (untreated or uncontrolled)
- NSAID-induced asthma diagnosed
- Systemic hypertension (SH) stage III uncontrolled
- Moderate and severe congestive heart failure
- Acute myocardial infarction
- unstable angina
- Uncontrolled cardiac arrhythmia
- Liver failure with clinical consequences
- Renal failure with clinical consequences
- Diagnosed HIV positive
- uncontrolled Diabetes type 1 or type 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: National Clinical Trial,Phase III, Multicenter, Randomized, Prospective, Double-blind, Parallel, Placebo-controlled, to Evaluate the Efficacy, Safety and Superiority of Decongex Gripe in the Treatment of Symptoms Associated With Common Cold
National clinical trial, phase III, multicenter, randomized, prospective, double-blind, parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged equal or more than 18 years will be randomly allocated to one the drug group or placebo group.
Read the detailed description
The investigational product is a combination of desloratadine, phenylephrine hydrochloride and ibuprofen.
The desloratadine is a antihistamine and selectively block the activity of histamine receptor-1 (H1) resulting in a non sedative and prolong antiallergic effect.
The phenylephrine is a potent stimulator of the postsynaptic α receptor with minimal effect on β receptors in the heart.
The ibuprofen's mechanism is not fully known. It is a non selective inhibitor of cyclooxygenase, an enzyme that is involved in prostaglandin synthesis by the route from arachidonic acid. It is believed that the pharmacological effects are due to inhibition of cyclooxygenase-2 (COX-2), which reduces prostaglandin synthesis involved in the mediation of inflammation, pain, fever and swelling.
- Conditions
- Cold
- Being tested
- Desloratadine+Phenylephrine+Ibuprofen, Placebo
- Keywords
- Flu, Treatment
- 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.
Desloratadine+Phenylephrine+IbuprofenDrug
Also called Desloratadine+Phenylephrine hydrochloride+Ibuprofen
01 tablet, orally, every 12 hours.
PlaceboDrug
01 tablet, orally, every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine+Phenylephrine+Ibuprofen | Experimental | It's a tablet manufactured by Aché S.A., composed of desloratadine 2,5mg, Phenylephrine hydrochloride 20mg and Ibuprofen 400mg.
Tablet will be dispensed in a cartridge containing 10 tablet to 75 participants. Receives: Drug: Desloratadine+Phenylephrine+Ibuprofen |
| Placebo | Placebo comparator | It's a tablet manufactured by Aché S.A,. composed of placebo will be dispensed in a cartridge containing 10 tablet to 75 participants. The participants shall administer the placebo tablets to enable the double-blind study.
The use of placebo comparator is important in this type of pathology because with this design will be able to evaluate the response of the pure treatment, rapid relief of symptoms, or 03 hours after the first administration of study drug. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the superiority of Desloratadine + Phenylephrine + Ibuprofen over placebo
To evaluate the association of the superiority fixed dose of desloratadine 2.5mg, 20mg phenylephrine hydrochloride and ibuprofen 400 mg compared to placebo in the treatment of symptoms related to the common cold / flu syndrome by varying the intensity total score of symptoms, three (03 ) hours after the first dose of investigational product.
Measured: 03 hours after the first dose
Secondary outcomes (4)
Evaluation of the symptoms related to the common cold / flu syndrome.
Absolute variation in total score intensity of symptoms related to the common cold / flu-like symptoms 02 days after the start of treatment compared to baseline.
Measured: 02 days after initiation of treatment, compared to baseline.
Satisfaction of the quality of sleep
Distribution of subjects in each treatment group as their perception to the sleep quality, assessed at baseline by answering the following statement: " Last night, with this cold, I did not sleep as well as I usually sleep "based on a scale of 0 to 4 points (0 = strongly disagree, 1 = disagree, 2 = neither agree nor disagree, 3 = agree and 4 = I totally agree).
Measured: On the first day and on the second day after the start of treatment.
The need for use of the rescue medication measured through the subject's diary.
Proportion of subject in each treatment group who used at least once the rescue medication (Tylenol®) in the first (Day 01) and on the second day (day 02) after treatment, measured through the subject's diary.
Measured: On the first day and on the second day after the start of treatment.
The need for use of the rescue medication according to accounting of rescue medication returned.
Proportion of subject in each treatment group who used at least once the rescue medication (Tylenol®) in the first (Day 01) and on the second day (day 02) after treatment, accounting of rescue medication (Tylenol®) returned.
Measured: On the first day and on the second day after the start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startDec 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: the viability of the study is being analyzed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mauro Crippa Jr., Principal investigator, Allergisa Pesquisa Dermato-Cosmética Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02904304
- Sponsor's protocol ID
- ACH-DNT-03(02/16)
- Status last verified
- Jul 2019
- First submitted
- 8 Mar 2016
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Clinical Trial,Phase III, Multicenter, Randomized, Prospective, Double-blind, Parallel, Placebo-controlled, to Evaluate the Efficacy, Safety and Superiority of Decongex Gripe in the Treatment of Symptoms Associated With Common Cold
- ClinicalTrials.gov ID
- NCT02904304
- Acronym / sponsor ID
- ACH-DNT-03(02/16)
- Conditions
- Cold
- Keywords
- Flu, Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: the viability of the study is being analyzed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 16 Sep 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.
National clinical trial, phase III, multicenter, randomized, prospective, double-blind, parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged equal or more than 18 years will be randomly allocated to one the drug group or placebo group.
Detailed description
The investigational product is a combination of desloratadine, phenylephrine hydrochloride and ibuprofen.
The desloratadine is a antihistamine and selectively block the activity of histamine receptor-1 (H1) resulting in a non sedative and prolong antiallergic effect.
The phenylephrine is a potent stimulator of the postsynaptic α receptor with minimal effect on β receptors in the heart.
The ibuprofen's mechanism is not fully known. It is a non selective inhibitor of cyclooxygenase, an enzyme that is involved in prostaglandin synthesis by the route from arachidonic acid. It is believed that the pharmacological effects are due to inhibition of cyclooxygenase-2 (COX-2), which reduces prostaglandin synthesis involved in the mediation of inflammation, pain, fever and swelling.
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 |
|---|---|---|
| Desloratadine+Phenylephrine+Ibuprofen | Experimental | Drug: Desloratadine+Phenylephrine+IbuprofenIt's a tablet manufactured by Aché S.A., composed of desloratadine 2,5mg, Phenylephrine hydrochloride 20mg and Ibuprofen 400mg. Tablet will be dispensed in a cartridge containing 10 tablet to 75 participants. |
| Placebo | Placebo comparator | Drug: PlaceboIt's a tablet manufactured by Aché S.A,. composed of placebo will be dispensed in a cartridge containing 10 tablet to 75 participants. The participants shall administer the placebo tablets to enable the double-blind study. The use of placebo comparator is important in this type of pathology because with this design will be able to evaluate the response of the pure treatment, rapid relief of symptoms, or 03 hours after the first administration of study drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age older or equal to 18 and younger than 66 years;
- Subjects diagnosed with common cold / flu syndrome defined by clinical evaluation and the presence of two or more of the following symptoms: sneezing, rhinorrhea, nasal obstruction, headache, throat discomfort, sore throat, dysphonia, myalgia, cough and fever classified as moderate or intense in four intensity scale (04) items (0 = absent, 01 = light, 02 = moderate, 03 = severe);
- Beginning of the symptoms of common cold / flu-like syndrome in a minimum period of 24 hours and a maximum of 72 hours prior to V0;
- Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF);
Key exclusion criteria (21 listed)
- Any laboratorial finding (clinical evaluation / physical evaluation / vital signs / ECG changes) that the Investigator consider a risk to subject of the study;
- Hypersensitivity to the drug components used during the study;
- Women in pregnancy or nursing period;
- Women in reproductive age who do not agree to use contraception acceptable [oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation]; other than surgically sterile (bilateral oophorectomy or hysterectomy), postmenopausal for at least one (01) years or sexual abstinence;
- Subjects that has participated in clinical trial protocols in the last twelve (12) months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;
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 |
|---|---|---|
| Desloratadine+Phenylephrine+IbuprofenAlso: Desloratadine+Phenylephrine hydrochloride+Ibuprofen01 tablet, orally, every 12 hours. | Drug | Desloratadine+Phenylephrine+Ibuprofen |
| Placebo01 tablet, orally, every 12 hours. | Drug | Placebo |
Primary outcome
Evaluation of the superiority of Desloratadine + Phenylephrine + Ibuprofen over placebo
Time frame: 03 hours after the first dose
To evaluate the association of the superiority fixed dose of desloratadine 2.5mg, 20mg phenylephrine hydrochloride and ibuprofen 400 mg compared to placebo in the treatment of symptoms related to the common cold / flu syndrome by varying the intensity total score of symptoms, three (03 ) hours after the first dose of investigational product.
4 secondary outcomes
Evaluation of the symptoms related to the common cold / flu syndrome.
Time frame: 02 days after initiation of treatment, compared to baseline.
Satisfaction of the quality of sleep
Time frame: On the first day and on the second day after the start of treatment.
The need for use of the rescue medication measured through the subject's diary.
Time frame: On the first day and on the second day after the start of treatment.
The need for use of the rescue medication according to accounting of rescue medication returned.
Time frame: On the first day and on the second day after the start of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
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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.
Mauro Crippa Jr. principal investigator
Allergisa Pesquisa Dermato-Cosmética Ltda
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 Desloratadine+Phenylephrine+Ibuprofen in people with Cold, run by Ache Laboratorios Farmaceuticos S.A. 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 4 inclusion and 21 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: paused, as of the sponsor's last update on 8 Jul 2019. 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?
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?
Evaluation of the superiority of Desloratadine + Phenylephrine + Ibuprofen over placebo (time frame: 03 hours after the first dose). 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 8 Jul 2019.