Nasal CongestionPhase 3NCT01199497
Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms, Suffering From Non-productive Cough and Acute Rhinitis
A Phase 3 study testing Group 1 and Group 2 in people with Nasal Congestion and Cough, run by Ache Laboratorios Farmaceuticos S.A..
Trial summary
Multicenter clinical trial, phase III, controlled by active medicine, double-blind, randomized, enroll 208 subjects, above 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Nasal Congestion, Cough
- What is being tested?
- Group 1 and Group 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Jan 2013
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 12 years old, of both sexes;
- Clinical condition compatible with acute rhinitis accompanied by nasal congestion;
- 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 congestion severity score (As per item 4.1.3);
- If necessary, ICF signed by a parent/representant, or in case the patient over 18 years old, his own signature;
- Patient and/or 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 (axilar 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;
- Female patients with positive b-HCG;
- Patients under treatment for chronic allergy;
- Presence of purulent or mucupurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;
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- 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/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, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms in Subjects Above 12 Years of Age, Suffering From Non-productive Cough and Acute Rhinitis.
Multicenter clinical trial, phase III, controlled by active medicine, double-blind, randomized, enroll 208 subjects, above 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
- Nasal Congestion, Cough
- Being tested
- Group 1, Group 2
- Keywords
- cough, acute rhinitis, nasal congestion, common cold, nasal symptoms, children., Nasal congestion and non-productive cough, with or without associate other nasal and extranasal symptoms.
- Medical subject headings
- Nasal Obstruction, Cough, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Drug
fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).
Group 2Drug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup). Receives: Drug: Group 1 |
| Group 2 | Placebo comparator | Placebo Receives: Drug: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary efficacy criteria
The changes of lung function parameter: pre-bronchodilator forced expiratory volume in first second (FEV1) including baseline and 24th week.
Measured: baseline and week 24
Secondary outcomes (1)
Secondary efficacy criteria
Changes in forced expiratory volume in first second (FEV1).
Measured: baseline, week 8, 16 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startAug 2011
- Primary completionAug 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal CongestionStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199497
- Sponsor's protocol ID
- ACH-NTS-03(08/10)
- Status last verified
- Jul 2017
- First submitted
- 9 Sep 2010
- Last updated
- 13 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Trial Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms in Subjects Above 12 Years of Age, Suffering From Non-productive Cough and Acute Rhinitis.
- ClinicalTrials.gov ID
- NCT01199497
- Acronym / sponsor ID
- ACH-NTS-03(08/10)
- Conditions
- Nasal Congestion, Cough
- Keywords
- cough, acute rhinitis, nasal congestion, common cold, nasal symptoms, children., Nasal congestion and non-productive cough, with or without associate other nasal and extranasal symptoms.
- 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
- Aug 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 13 Sep 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, double-blind, randomized, enroll 208 subjects, above 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Group 1Fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup). |
| Group 2 | Placebo comparator | Drug: Group 2Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Patients over 12 years old, of both sexes;
- Clinical condition compatible with acute rhinitis accompanied by nasal congestion;
- 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 congestion severity score (As per item 4.1.3);
Key exclusion criteria (17 listed)
- Non-productive cough with purulent smear, fever (axilar 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;
- Female patients with positive b-HCG;
- Patients under treatment for chronic allergy;
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 |
|---|---|---|
| Group 1fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup). | Drug | Group 1 |
| Group 2placebo | Drug | Group 2 |
Primary outcome
Primary efficacy criteria
Time frame: baseline and week 24
The changes of lung function parameter: pre-bronchodilator forced expiratory volume in first second (FEV1) including baseline and 24th week.
1 secondary outcome
Secondary efficacy criteria
Time frame: baseline, week 8, 16 and 24
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 13 Jul 2017.
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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 Group 1 and Group 2 in people with Nasal Congestion 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 17 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 13 Jul 2017. 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. 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?
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?
Primary efficacy criteria (time frame: baseline and week 24). 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 13 Jul 2017; AzTrials last refreshed its copy on 6 Nov 2026.