NCT00230230

Comparison of SCH 486757 to Codeine and Placebo in Subjects With Persistent Postviral Cough (Study P03069AM2)(COMPLETED)

SCH 486757 vs Codeine and Placebo in Subjects With Persistent Postviral Cough

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	SCH 486757

Timeline

• Start date: 2005-10-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2005-09-30
• Last updated: 2015-09-16