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Trial record 60 of 450 for:    diphenhydramine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01199497
Recruitment Status : Withdrawn
First Posted : September 13, 2010
Last Update Posted : July 13, 2017
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.

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.

Condition or disease Intervention/treatment Phase
Nasal Congestion Cough Drug: Group 1 Drug: Group 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : August 2011
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: Group 1
Fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).
Drug: Group 1
fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).

Placebo Comparator: Group 2
Drug: Group 2

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Secondary efficacy criteria [ Time Frame: baseline, week 8, 16 and 24 ]
    Changes in forced expiratory volume in first second (FEV1).

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Responsible Party: Ache Laboratorios Farmaceuticos S.A. Identifier: NCT01199497     History of Changes
Other Study ID Numbers: ACH-NTS-03(08/10)
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
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.
Additional relevant MeSH terms:
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Sleep Aids, Pharmaceutical
Common Cold
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Autonomic Agents
Gastrointestinal Agents
Histamine H1 Antagonists