Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections.
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | March 6, 2009 | ||||
| Last Updated Date | January 27, 2011 | ||||
| Start Date ICMJE | April 2010 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
- 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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Decrease in nasal secretion Reduction of edema of the nasal mucosa of breathing Improves Decreased frequency of cough Decrease the frequency of dyspnea reduction of nasal obstruction [ Time Frame: Screening (Day 0); Return to 3 days (+/-1); Return of 7 days (+ / -2) ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00857987 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
Will be assessed for safety by the incidence of adverse reactions [ Time Frame: Screening (Day 0); Return to 3 days (+/-1); Return of 7 days (+ / -2) ] [ Designated as safety issue: Yes ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections. | ||||
| Official Title ICMJE | 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) | ||||
| Brief Summary | Evaluate the improvement of the common cold with the use of medication |
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| 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:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Upper Airway Infections | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 174 | ||||
| Estimated Completion Date | December 2011 | ||||
| Estimated Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 12 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00857987 | ||||
| Other Study ID Numbers ICMJE | GADEMS0109, GADEMS0109 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Alexandre Frederico, LAL Clinica | ||||
| Study Sponsor ICMJE | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | L.A.L Clinica Pesquisa e Desenvolvimento Ltda. | ||||
| Verification Date | January 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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