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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00230230 |
This randomized, multicenter, parallel-group, double-blind, double-dummy, placebo- and active-controlled study will evaluate the efficacy and safety of SCH 486757 in subjects with persistent cough resulting from a recent viral upper respiratory infection (URI). The primary objective is to assess the efficacy of SCH 486757 administered at a dose of 100 mg twice daily for 5 days in the reduction of cough severity score compared with placebo. The key secondary objective is to evaluate the reduction in the number of coughs with SCH 486757 compared with placebo. Because codeine is a widely used as a cough medication, it is included as a treatment arm in the study.
Condition | Intervention | Phase |
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Cough |
Drug: SCH 486757 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | SCH 486757 vs Codeine and Placebo in Subjects With Persistent Postviral Cough |
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | P03069 |
Study First Received: | September 22, 2005 |
Last Updated: | May 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00230230 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Signs and Symptoms Respiratory Tract Diseases Respiration Disorders |
Signs and Symptoms, Respiratory Cough Codeine |