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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
ClinicalTrials.gov Identifier:
NCT00857987
First received: March 6, 2009
Last updated: January 27, 2011
Last verified: January 2011
  Purpose

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


Condition Intervention Phase
Upper Airway Infections
Drug: EMS Expectorant
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized , Placebo-controlled, Clinical Trial of Efficacy and Safety Evaluation of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improving the Signs and Symptoms of Infections of Way Upper (URI)

Resource links provided by NLM:


Further study details as provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:

Primary Outcome Measures:
  • - 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 [ Time Frame: Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Will be assessed for safety by the incidence of adverse reactions [ Time Frame: Screening (Day 0); Return to 1 day; Return to 3 days (+/-1); Return of 7 days (+ / -2) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 174
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Guaifenesin, doxylamine succinate and hydrochloride etafedrine syrup
Drug: EMS Expectorant
Guaifenesin - 100mg, Etafedrine hydrochloride 20mg, Succinate doxilamine 6mg.
Placebo Comparator: 2
Vehicle
Other: Placebo
Vehicle

Detailed Description:

Patients with signs and symptoms of URI will be forwarded to the Research Center for a screening in which the researchers will select those meet the inclusion criteria. This visit will be informed of the objectives study, methodology, risks and benefits, the right of patients to give up research, the confidentiality of data and other details that provide the the patients to consider their participation basement viable or not. All aspects relevant to the consideration of the patient on their participation will described in the Informed Consent, which will be read and signed before any procedure. The patients included are randomized, open treatment immediately and will be sent to perform a radiological examination (Rx - sinus of the face). This examination used to detect other clinical pictures than URI. After 24 hours (visit 02), the patient will return for the assessment and clinical questions about their symptoms, which provide the scores of efficacy of the product. This visit will review the radiological examination, and on the finding that infection of sinuses without symptoms, the patient will excluded because of antibiotic use will begin. In return for three days (visit 03), patients will again evaluated in relation to their clinical status. On this visit, the doctor may take the following behaviors:

  • Patients who have no clinical symptoms get high.
  • Patients who have not improved, take a dose of medicine increased.
  • The worsening of the present that, due to infections bacterial or other clinical pictures, will be excluded and referred to a general practitioner employed by the sponsor. In return for seven days, patients should return the products and again participate in a clinical consultation, in which researchers may take the following behaviors:
  • Patients who have no clinical symptoms get high.
  • Patients who have not improved or have worsened will be exempted from study and referred to the general practitioner hired by the sponsor is repeated for the diagnosis and establish a new treatment. Will be allowed the use of rescue medications such as paracetamol or sodium dipyrone, justified by the existence of the placebo group and those products do not interfere in the results evaluated, it was a pain and antipyretics.
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857987

Contacts
Contact: Karina Guerra, Coordinator 55 19 3829-3822 karina@lalclinica.com.br

Locations
Brazil
LAL Clinica Pesquisa e Desenvolvimento Ltda Recruiting
Valinhos, SP, Brazil, 13270000
Contact: Karina Guerra, Coordinator    55 19 3829 3822    karina@lalclinica.com.br   
Principal Investigator: Alexandre Frederico, Doctor         
Sponsors and Collaborators
L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
  More Information

No publications provided

Responsible Party: Alexandre Frederico, LAL Clinica
ClinicalTrials.gov Identifier: NCT00857987     History of Changes
Other Study ID Numbers: GADEMS0109, GADEMS0109
Study First Received: March 6, 2009
Last Updated: January 27, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by L.A.L Clinica Pesquisa e Desenvolvimento Ltda.:
IRA, Guaifenesin, Etaphedrine, Doxilamine

Additional relevant MeSH terms:
Communicable Diseases
Infection
Chlorpheniramine, phenylpropanolamine drug combination
Doxylamine
Doxylamine succinate
Expectorants
Guaifenesin
Phenylpropanolamine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Anti-Obesity Agents
Antiemetics
Appetite Depressants
Autonomic Agents
Cardiovascular Agents
Central Nervous System Agents
Gastrointestinal Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014