Status:
COMPLETED
Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds
Lead Sponsor:
Deborah Gentile
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Upper Respiratory Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.
Detailed Description
This is a randomized double-blinded placebo controlled trial to assess the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respirato...
Eligibility Criteria
Inclusion
- Adults 18 to 50 years of age.
- Male or female, who are not pregnant or lactating.
- Common cold symptoms for less than 24 hours.
- At least 2 of the following 9 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratch throat, sneezing and malaise.
Exclusion
- Investigational medication in past 30 days.
- Known hypersensitivity to any ingredients in study medication.
- History of asthma or other chronic diseases.
- Females of childbearing potential who are not using a medically acceptable form of birth control.
- Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.
- Females with a positive urinary HCG test.
- Patients with a positive rapid antigen test for streptococcal infection.
- Common cold symptoms for more than 24 hours.
- Patients who are users of illicit drugs.
- Patients who are on rifampin or phenobarbital.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00189475
Start Date
October 1 2003
End Date
July 1 2007
Last Update
November 18 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212