Back to resultsDesloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu
Primary Purpose
Cold
Status
Suspended
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Desloratadine+Phenylephrine+Ibuprofen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cold focused on measuring Flu, Treatment
Eligibility Criteria
Inclusion Criteria:
- 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);
Exclusion Criteria:
- 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;
- 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
Sites / Locations
- Allergisa Pesquisa Dermato Cosmética Ltda.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Desloratadine+Phenylephrine+Ibuprofen
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
Full Information
NCT ID
NCT02904304
First Posted
March 8, 2016
Last Updated
July 3, 2019
Sponsor
Ache Laboratorios Farmaceuticos S.A.
1. Study Identification
Unique Protocol Identification Number
NCT02904304
Brief Title
Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Suspended
Why Stopped
the viability of the study is being analyzed
Study Start Date
December 2020 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ache Laboratorios Farmaceuticos S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold
Keywords
Flu, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Desloratadine+Phenylephrine+Ibuprofen
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Desloratadine+Phenylephrine+Ibuprofen
Other Intervention Name(s)
Desloratadine+Phenylephrine hydrochloride+Ibuprofen
Intervention Description
01 tablet, orally, every 12 hours.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
01 tablet, orally, every 12 hours.
Primary Outcome Measure Information:
Title
Evaluation of the superiority of Desloratadine + Phenylephrine + Ibuprofen over placebo
Description
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.
Time Frame
03 hours after the first dose
Secondary Outcome Measure Information:
Title
Evaluation of the symptoms related to the common cold / flu syndrome.
Description
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.
Time Frame
02 days after initiation of treatment, compared to baseline.
Title
Satisfaction of the quality of sleep
Description
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).
Time Frame
On the first day and on the second day after the start of treatment.
Title
The need for use of the rescue medication measured through the subject's diary.
Description
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.
Time Frame
On the first day and on the second day after the start of treatment.
Title
The need for use of the rescue medication according to accounting of rescue medication returned.
Description
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.
Time Frame
On the first day and on the second day after the start of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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);
Exclusion Criteria:
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;
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Crippa Jr.
Organizational Affiliation
Allergisa Pesquisa Dermato-Cosmética Ltda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergisa Pesquisa Dermato Cosmética Ltda.
City
Campinas
State/Province
São Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu
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