Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections.

NCT00857987 | Unknown Phase 3 DMC

• 1 other identifier: GADEMS0109
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the improvement of the common cold with the use of medication

Conditions

Upper Airway Infections

Keywords

IRA, Guaifenesin, Etaphedrine, Doxilamine

Outcome Measures

Primary Outcomes (1)

• - Decrease in nasal secretion - Decrease in sneezing - Reduction of edema of the nasal mucosa - Decreased frequency of cough - Decrease the frequency of dyspnea - Reduction of nasal obstruction

  Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2)

Secondary Outcomes (1)

• Will be assessed for safety by the incidence of adverse reactions

  Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2)

Study Arms (2)

1

EXPERIMENTAL

Guaifenesin, doxylamine succinate and hydrochloride etafedrine syrup

Drug: EMS Expectorant

2

PLACEBO COMPARATOR

Vehicle

Other: Placebo

Interventions

EMS Expectorant DRUG

Guaifenesin - 100mg, Etafedrine hydrochloride 20mg, Succinate doxilamine 6mg.

1

Placebo OTHER

Vehicle

2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who take part in the study, agreeing with the terms proposed in FICT;
• Patients aged 12 years or above of any ethnicity, class or social group;
• Patients of both sexes;
• Patients with good mental health;
• Patient with acute respiratory disease of the upper airways of viral etiology (URI);
• Patient with the early signs and symptoms of URI with minimum time of failure greater than 48 hours.

You may not qualify if:

• Patients treated with antibiotics or predict the use of antibiotics for other clinical condition;
• Presence of bacterial tables of the upper airways and lungs (bacterial sinusitis, pneumonia, etc.).
• Patient with cystic fibrosis;
• Primary or metastatic cancer to the lung;
• Presence of respiratory tables with more than 14 days in duration;
• Treatment with immunosuppressive drugs;
• Presence of any medical or psychological condition that, at the discretion of the investigator, should prevent the patient from the study;
• History of abuse of alcohol or drugs;
• Participation in clinical trials in the six months preceding the study;
• Patients with severe pulmonary diseases, which require multi-drug treatment;
• Presence of other concomitant pulmonary diseases;
• Pregnancy and lactation;
• History of hypersensitivity to drugs of the same pharmacological classes of substances under investigation.

Sponsors & Collaborators

• Azidus Brasil: lead

Study Sites (1)

LAL Clinica Pesquisa e Desenvolvimento Ltda

Valinhos, São Paulo, 13270000, Brazil

RECRUITING

Central Study Contacts

Karina Guerra, Coordinator

CONTACT

55 19 3829-3822; karina@lalclinica.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 28, 2011

Record last verified: 2011-01

Locations

BR (1)