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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

NCT01199497 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2017-07-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Group 1

fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).

DRUG

Group 2

placebo

Sponsors & Collaborators

  • Ache Laboratorios Farmaceuticos S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-08-31
Completion
2013-01-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01199497 on ClinicalTrials.gov