- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01177852
Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis
Multicenter Clinical Trial, Phase III, Controlled, Open, Parallel Group, Randomized, Comparing the Fixed Dose Combination of Diphenhydramine + Dropropizine + Pseudoephedrine and the Combined Use of Dropropizine and Fixed Dose Combination of Pseudoephedrine Hydrochloride + Brompheniramine Maleate Used Orally for Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2 to 12 Years Old, Suffering From Non-productive Cough and Acute Rhinitis.
Study Overview
Status
Conditions
Study Type
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients between 2 and 12 years old, of both sexes;
- Clinical condition compatible with acute rhinitis accompanied by nasal obstruction;
- Non-productive cough, daytime and/or nighttime with at least 3 and up 5 consecutive days in duration;
- Score greater than or equal to 3 points on the cough severity score (As per item 4.1.2);
- Score greater than or equal to 2 points on the nasal obstruction severity score (As per item 4.1.3);
- ICF signed by a parent/caregiver/representant;
- Parent/Caregiver/Representant capacity, according to investigator evaluation, for compliance at the treatment and protocol requirements, fulfilling the regular visits;
Exclusion Criteria:
- Non-productive cough with purulent smear, fever (axillar temperature superior than 37,8°C/100°F), purulent runny nose and other signs and symptoms of bacteria infection of upper and lower airways at 7 days before the screening/randomization visit;
- Septal deviation level III (in any region and any nasal cavity) and/or nasal polyps or other determinants conditions of nasal congestion;
- Previous diagnosis of asthma;
- Patients under treatment for chronic allergy;
- Presence of purulent or mucopurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;
- Current use of systemic antibiotics for any reason;
- Use of prohibited medicine within the prescribed period before V0 as shown in item 9.3 of this protocol;
- Participation in last one year of clinical protocols;
- Any psychiatric diseases, including major depression;
- Presence of mental retardation from any cause;
- Diagnosis of renal or hepatic failure;
- History of hypersensitivity to any component of the study drugs;
- Relatives of sponsor´s or study site´s employee;
- Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the patient participation;
- Patient or parent/caregiver/representant with a history of lack of compliance to treatment or previous treatment protocols;
- Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (eg, blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the patient or interfere with the endpoints of study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Notuss® syrup
Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).
|
Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup). Posology: The medicine treat will be as follows: - Notuss® syrup Age: 2-5 years / Dosage: 5,0 mL Age: 6-12 years / Dosage: 10,0 ml |
Active Comparator: Dropropizine + Pseudoephedrine and brompheniramine
Group 2: combined use of dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate.
|
Dropropizine: Age: 2 - 3 years / Dosage: 5,0 ml Age: 4 - 12 years / Dosage: 10,0 ml Pseudoephedrine hydrochloride + brompheniramine maleate: Age: 2 - 3 years / Dosage: 2,5 ml Age: 4 - 6 years / Dosage: 5,0 ml Age: 7 - 9 years / Dosage: 7,5 ml Age: 10 - 12 years / Dosage: 10,0 ml |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of nasal congestion and cough
Time Frame: Evaluated on the day 2 after beginning treatment
|
Participants were evaluated (by a parent/guardian/caregivers) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.
|
Evaluated on the day 2 after beginning treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement of nasal congestion and cough
Time Frame: Evaluated on the 7(±1) day after beginning treatment
|
Participants were evaluated (by a parent/guardian/caregivers) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.
|
Evaluated on the 7(±1) day after beginning treatment
|
Improvement of non-obstructive nasal symptoms
Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
|
Participants were evaluated (by a parent/guardian/caregivers for pain intensity by using a sum of 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe.
|
Evaluated on the day 2 and 7 (±1) after beginning treatment
|
Reduction of the frequency of nighttime awakenings of parent/guardian/roommate of the child
Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
|
Evaluated on the day 2 and 7 (±1) after beginning treatment
|
|
Reduction of vomiting frequency episodes triggered by coughing
Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
|
Evaluated on the day 2 and 7 (±1) after beginning treatment
|
|
Improvement of acute rhinitis signs
Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
|
Assessed by anterior rhinoscopy and application of specific clinical scores
|
Evaluated on the day 2 and 7 (±1) after beginning treatment
|
Use of rescue medication
Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
|
Evaluated on the day 2 and 7 (±1) after beginning treatment
|
|
Overall impression of improvement by the investigator
Time Frame: Evaluated on the day 2 and 7 (±1) after beginning treatment
|
Specific scale and overall impression of improvement by a parent/guardian/ caregiver of the child
|
Evaluated on the day 2 and 7 (±1) after beginning treatment
|
Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.
Time Frame: Will be evaluated during the 7(± 1) days of treatment
|
Collection of safety data throughout the whole study period
|
Will be evaluated during the 7(± 1) days of treatment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Respiration Disorders
- Otorhinolaryngologic Diseases
- Picornaviridae Infections
- Signs and Symptoms, Respiratory
- Nose Diseases
- Inflammation
- Rhinitis
- Cough
- Common Cold
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Hypnotics and Sedatives
- Anesthetics, Local
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Sleep Aids, Pharmaceutical
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Central Nervous System Stimulants
- Antitussive Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Nasal Decongestants
- Diphenhydramine
- Promethazine
- Ephedrine
- Pseudoephedrine
- Brompheniramine
- Brompheniramine, pseudoephedrine drug combination
- Dipropizine
Other Study ID Numbers
- ACH-NTS-03(02/10)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inflammation
-
University of EdinburghUmeå UniversityCompletedSystemic Inflammation | Respiratory InflammationSweden
-
University of AarhusAarhus University Hospital; University of CopenhagenCompletedSystemic Inflammation | Airway InflammationDenmark
-
Sykehuset TelemarkRikshospitalet University Hospital; Helse Sor-OstCompletedAirway Inflammation | Peripheral Blood Inflammation Markers | Cement Dust ExposureNorway
-
Assistance Publique - Hôpitaux de ParisCompletedDigestive InflammationFrance
-
Pamukkale UniversityCompletedPeriodontal InflammationTurkey
-
Universidade Federal do ParaCompleted
-
KLE Society's Institute of Dental SciencesCompletedRegenerative InflammationIndia
-
Fondation Ophtalmologique Adolphe de RothschildCompleted
-
Oral Science International Inc.AdvarraNot yet recruiting
Clinical Trials on diphenhydramine + dropropizine + pseudoephedrine
-
Johnson & Johnson Consumer and Personal Products...CompletedNasal CongestionUnited States
-
University College, LondonKing Abdulaziz UniversityCompleted
-
Vanderbilt UniversityNational Heart, Lung, and Blood Institute (NHLBI); National Center for Advancing...Terminated
-
Montefiore Medical CenterCompletedCough Reflex SensitivityUnited States
-
Fraunhofer-Institute of Toxicology and Experimental...Completed
-
Ranbaxy Laboratories LimitedCompleted
-
SanofiCompleted
-
University of Maryland, BaltimoreCompletedBarotrauma;EarUnited States
-
ClinvestOrtho-McNeil Neurologics, Inc.CompletedMigraine | SinusitisUnited States
-
BayerCompleted