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SCH 486757 in Chronic Idiopathic Cough
NCT00506987Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2007
- Primary completion
- Nov 2007
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- SCH-486757
- Conditions
- chronic idiopathic cough (CIC)
01
Overview
Phase 2, randomised, double-blind trial in chronic idiopathic cough (CIC) comparing SCH 486757 with Placebo (2 arms). Primary endpoint: Change from baseline in cough reflex sensitivity as assessed by log10 C5 resulting from a capsaicin challenge at 2 weeks. Started Jan 2007; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
SCH 486757
SCH 486757 2 x 50-mg capsule twice daily
Placebo
Matching placebo capsules twice daily
03
Who it enrols
Adults 18-65 with chronic dry cough >6 months, unresponsive to prior GERD, postnasal drip, or asthma treatments. Excludes smokers, diabetics, uncontrolled hypertensives, and those on ACE inhibitors or prohibited medications.
04
Endpoints
Primary
Change from baseline in cough reflex sensitivity as assessed by log10 C5 resulting from a capsaicin challenge
Secondary
Change from baseline in hourly cough rate over 24 hours
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