Status:
WITHDRAWN
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
Lead Sponsor:
Ache Laboratorios Farmaceuticos S.A.
Conditions:
Nasal Congestion
Cough
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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 no...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01199497
Start Date
August 1 2011
End Date
January 1 2013
Last Update
July 13 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.