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

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.

Timeline

Start

2005-10

Primary completion

2007-04

Completion

2007-04

Outcome

Missed primary endpoint

paper between SCH486757 and placebo [mean change = -0.57 (-30.1%) vs. mean change = -0.49 (-19.7%); P = 0.56] PMID 19937046 ↗

Publications

• Results Woodcock A, McLeod RL, Sadeh J, Smith JA. The efficacy of a NOP1 agonist (SCH486757) in subacute cough. Lung. 2010 Jan;188 Suppl 1:S47-52. doi: 10.1007/s00408-009-9197-8.

Drugs

Indications

No indication recorded.