Postviral cough
Conditions
Interventions
Product Name: SCH 486757 capsules
Product Code: SCH 486757
Pharmaceutical Form: Capsule*
INN or Proposed INN: NA
CAS Number: 524019-25-8
Sponsors
Schering Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Sufficiently symptomatic- cough severity score of at least moderate at Visit 2 (Screening). Must have had signs and symptoms indicative of a viral upper respiratory infection with an onset of at least 14 days, but not more than 90 days prior to the Pre-Screening Visit (Visit 1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnancy/Lactation Use of concurrent prohibited medications unless they observe the washout period prior to the Screening and Baseline Visits (Visits 2 and 3). (including opioid- and non-opioid-containing cough suppressants, proton pump inhibitors, H2 receptor antagonists and potent CYP3A inhibitors, such as ritonavir, ketoconazole, and clarithromycin). Subjects receiving ACE inhibitors or MAOIs will be excluded from the study. Asthma or chronic obstructive pulmonary disease that requires chronic use of inhaled or systemic corticosteroids current or history of frequent clinically significant sinusitis or chronic purulent postnasal drip. history of allergies to more than two classes of medications or with an allergy to Lycra®. Current smokers, ex-smokers who stopped smoking in the previous 6 months, or subjects with a cumulative smoking history >10 pack-years will be excluded. Subjects with current gastroesophageal reflux disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess effectiveness of SCH 486757 (100 mg BID) in the reduction of cough severity score compared with placebo.; Secondary Objective: Evaluate the number of coughs from LifeShirt values. Evaluate safety profile of SCH 486757 using subject reported adverse events, ECGs, routine lab tests, vital signs evaluations, and the Stanford Sleepiness Scale. Estimate the magnitude of exposure to SCH 486757 following 5 days of dosing of SCH 486757 100 mg BID. ;Primary end point(s): Reduction from baseline values in the cough severity score as measured twice daily in the subject diary averaged over the 5 days of the study. | — |
Countries
United Kingdom
Outcome results
None listed