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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

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ClinicalTrials.gov Identifier: NCT01199497
Recruitment Status : Withdrawn
First Posted : September 13, 2010
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.

Tracking Information
First Submitted Date  ICMJE September 9, 2010
First Posted Date  ICMJE September 13, 2010
Last Update Posted Date July 13, 2017
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2011)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01199497 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2011)
Secondary efficacy criteria [ Time Frame: baseline, week 8, 16 and 24 ]
Changes in forced expiratory volume in first second (FEV1).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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.
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Nasal Congestion
  • Cough
Intervention  ICMJE
  • Drug: Group 1
    fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).
  • Drug: Group 2
    placebo
Study Arms  ICMJE
  • Experimental: Group 1
    Fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).
    Intervention: Drug: Group 1
  • Placebo Comparator: Group 2
    Placebo
    Intervention: Drug: Group 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 18, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2010)
208
Estimated Study Completion Date  ICMJE January 2013
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients over 12 years old, of both sexes;
  2. Clinical condition compatible with acute rhinitis accompanied by nasal congestion;
  3. Non-productive cough, daytime and/or nighttime with at least 3 and up 5 consecutive days in duration;
  4. Score greater than or equal to 3 points on the cough severity score (As per item 4.1.2);
  5. Score greater than or equal to 2 points on the nasal congestion severity score (As per item 4.1.3);
  6. If necessary, ICF signed by a parent/representant, or in case the patient over 18 years old, his own signature;
  7. Patient and/or representant capacity, according to investigator evaluation, for compliance at the treatment and protocol requirements, fulfilling the regular visits;

Exclusion Criteria:

  1. 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;
  2. Septal deviation level III (in any region and any nasal cavity) and/or nasal polyps or other determinants conditions of nasal congestion;
  3. Previous diagnosis of asthma;
  4. Female patients with positive b-HCG;
  5. Patients under treatment for chronic allergy;
  6. Presence of purulent or mucupurulent secretion, nasal vault or mal formations (cleft lip or cleft nasolabial corrected or not) in nasal vestibule;
  7. Current use of systemic antibiotics for any reason;
  8. Use of prohibited medicine within the prescribed period before V0 as shown in item 9.3 of this protocol;
  9. Participation in last one year of clinical protocols;
  10. Any psychiatric diseases, including major depression;
  11. Presence of mental retardation from any cause;
  12. Diagnosis of renal or hepatic failure;
  13. History of hypersensitivity to any component of the study drugs;
  14. Relatives of sponsor´s or study site´s employee;
  15. Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the patient participation;
  16. Patient or parent/representant with a history of lack of compliance to treatment or previous treatment protocols;
  17. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01199497
Other Study ID Numbers  ICMJE ACH-NTS-03(08/10)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ache Laboratorios Farmaceuticos S.A.
Study Sponsor  ICMJE Ache Laboratorios Farmaceuticos S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ache Laboratorios Farmaceuticos S.A.
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP