InflammationPhase 3NCT01177852
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
A Phase 3 study testing diphenhydramine + dropropizine + pseudoephedrine and Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir). in people with Inflammation and Cough, run by Ache Laboratorios Farmaceuticos S.A..
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Inflammation, Cough, Rhinitis
- What is being tested?
- diphenhydramine + dropropizine + pseudoephedrine and Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Apr 2012
- 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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
About this study
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.
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.
- Conditions
- Inflammation, Cough, Rhinitis
- Being tested
- diphenhydramine + dropropizine + pseudoephedrine, Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).
- Keywords
- cough, acute rhinitis, common cold, nasal symptoms, children., Acute inflammation upper airway
- Medical subject headings
- Inflammation, Cough, Rhinitis, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diphenhydramine + dropropizine + pseudoephedrineDrug
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
Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Notuss® syrup | Experimental | Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup). Receives: Drug: diphenhydramine + dropropizine + pseudoephedrine |
| Dropropizine + Pseudoephedrine and brompheniramine | Active comparator | Group 2: combined use of dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate. Receives: Drug: Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluated on the day 2 after beginning treatment
Secondary outcomes (8)
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.
Measured: Evaluated on the 7(±1) day after beginning treatment
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.
Measured: 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
Measured: Evaluated on the day 2 and 7 (±1) after beginning treatment
Reduction of vomiting frequency episodes triggered by coughing
Measured: Evaluated on the day 2 and 7 (±1) after beginning treatment
Improvement of acute rhinitis signs
Assessed by anterior rhinoscopy and application of specific clinical scores
Measured: Evaluated on the day 2 and 7 (±1) after beginning treatment
Use of rescue medication
Measured: Evaluated on the day 2 and 7 (±1) after beginning treatment
Overall impression of improvement by the investigator
Specific scale and overall impression of improvement by a parent/guardian/ caregiver of the child
Measured: 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.
Collection of safety data throughout the whole study period
Measured: Will be evaluated during the 7(± 1) days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startOct 2011
- Primary completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177852
- Sponsor's protocol ID
- ACH-NTS-03(02/10)
- Status last verified
- Oct 2016
- First submitted
- 6 Aug 2010
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01177852
- Acronym / sponsor ID
- ACH-NTS-03(02/10)
- Conditions
- Inflammation, Cough, Rhinitis
- Keywords
- cough, acute rhinitis, common cold, nasal symptoms, children., Acute inflammation upper airway
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Apr 2012 (estimated)
- First posted
- 9 Aug 2010 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Notuss® syrup | Experimental | Drug: diphenhydramine + dropropizine + pseudoephedrineGroup 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup). |
| Dropropizine + Pseudoephedrine and brompheniramine | Active comparator | Drug: Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).Group 2: combined use of dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (16 listed)
- 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;
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 |
|---|---|---|
| diphenhydramine + dropropizine + pseudoephedrineGroup 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 | Drug | Notuss® syrup |
| Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).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 | Drug | Dropropizine + Pseudoephedrine and brompheniramine |
Primary outcome
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.
8 secondary outcomes
Improvement of nasal congestion and cough
Time frame: 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
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
Reduction of vomiting frequency episodes triggered by coughing
Time frame: 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
Use of rescue medication
Time frame: 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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing diphenhydramine + dropropizine + pseudoephedrine and Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir). in people with Inflammation and Cough, run by Ache Laboratorios Farmaceuticos 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 7 inclusion and 16 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: withdrawn, as of the sponsor's last update on 19 Oct 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement of nasal congestion and cough (time frame: Evaluated on the day 2 after beginning treatment). 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 19 Oct 2016.