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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

Primary Purpose

Inflammation, Cough, Rhinitis

Status

Withdrawn

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

diphenhydramine + dropropizine + pseudoephedrine

Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).

About this trial

This is an interventional treatment trial for Inflammation focused on measuring cough, acute rhinitis, common cold, nasal symptoms, children., Acute inflammation upper airway

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Notuss® syrup

Dropropizine + Pseudoephedrine and brompheniramine

Arm Description

Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).

Group 2: combined use of dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate.

Outcomes

Primary Outcome Measures

Improvement of nasal congestion and cough

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.

Secondary Outcome Measures

Improvement of nasal congestion and cough

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.

Improvement of non-obstructive nasal symptoms

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.

Reduction of the frequency of nighttime awakenings of parent/guardian/roommate of the child

Reduction of vomiting frequency episodes triggered by coughing

Improvement of acute rhinitis signs

Assessed by anterior rhinoscopy and application of specific clinical scores

Use of rescue medication

Overall impression of improvement by the investigator

Specific scale and overall impression of improvement by a parent/guardian/ caregiver of the child

Safety descriptive about occurence of adverse events, evaluation of results of general physical examination.

Collection of safety data throughout the whole study period

Full Information

NCT ID

NCT01177852

First Posted

August 6, 2010

Last Updated

October 18, 2016

Sponsor

Ache Laboratorios Farmaceuticos S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01177852

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Withdrawn

Study Start Date

October 2011 (undefined)

Primary Completion Date

April 2012 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Ache Laboratorios Farmaceuticos S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Multicenter clinical trial, phase III, controlled by active medicine, open, randomized, enroll 962 children, 2 to 12 years old, that suffer acute inflammation upper airway characterized by non-productive cough, daytime/nighttime, with duration for at least 3 and no more than 5 consecutive days (without systemic/topic use of medication during this period) followed by nasal congestion, with or without associate other nasal symptoms (sneezing, runny nose, nasal itching and/or mouth breathing). The subjects will be allocated in 2 parallel groups, and will receive the medicines of study, according of the randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammation, Cough, Rhinitis

Keywords

cough, acute rhinitis, common cold, nasal symptoms, children., Acute inflammation upper airway

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Notuss® syrup

Arm Type

Experimental

Arm Description

Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).

Arm Title

Dropropizine + Pseudoephedrine and brompheniramine

Arm Type

Active Comparator

Arm Description

Group 2: combined use of dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate.

Intervention Type

Drug

Intervention Name(s)

diphenhydramine + dropropizine + pseudoephedrine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement of nasal congestion and cough

Description

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.

Time Frame

Evaluated on the day 2 after beginning treatment

Secondary Outcome Measure Information:

Title

Improvement of nasal congestion and cough

Description

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.

Time Frame

Evaluated on the 7(±1) day after beginning treatment

Title

Improvement of non-obstructive nasal symptoms

Description

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.

Time Frame