Clinical Trial: Phase II Open-Label Pilot Study of V3381 in Chronic Cough
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Phase II Open-label Pilot Study of V3381, a Novel N-Methyl-D-Aspartate Receptor Antagonist, in Chronic Cough Patients Attending a Specialist Clinic
Brief Summary: The investigators hypothesise that cough reflex hypersensitivity, demonstrated in chronic cough patients, is due to a phenomenon known as central sensitisation. Central sensitisation is a hyper-excitability of the sensory nerves as they join the central nervous system, and is believed to be mediated by the N-Methyl-D-Aspartate (NMDA) receptor[1-3].
Detailed Summary:
Sponsor: Vernalis (R&D) Ltd
Current Primary Outcome: Objective cough frequency at 8 weeks compared to baseline. [ Time Frame: 8 Weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in objective cough frequency at 4 weeks. [ Time Frame: 4 Weeks ]
- Change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) at 4 and 8 weeks. [ Time Frame: 4 and 8 Weeks ]
- Change in Global Rating of Change Scale at 1 week, 2 weeks, 4 weeks and 8 weeks [ Time Frame: 1 Week, 2 Weeks, 4 Weeks and 8 Weeks ]
Original Secondary Outcome: Same as current
Information By: Vernalis (R&D) Ltd
Dates:
Date Received: July 21, 2011
Date Started: October 2009
Date Completion:
Last Updated: July 22, 2011
Last Verified: July 2011
