A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02233699
• Date of registration: 29/08/2014
• Prospective Registration: No
• Primary sponsor: Xention Ltd
• Public title: A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough
• Scientific title: A Double-blind, Randomised, Placebo-controlled, Crossover Study to Assess the Efficacy of XEN-D0501, a Transient Receptor Potential Vanilloid Receptor 1 (TRPV1) Antagonist, in Reducing the Frequency of Cough in Patients With Chronic Idiopathic Cough.
• Date of first enrolment: July 2014
• Target sample size: 18
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02233699
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Ireland, United Kingdom

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male/female subjects aged 18 or over with chronic idiopathic cough

Exclusion Criteria:

- Clinically significant medical history

- Abnormal laboratory results, ECGs or vital signs



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Idiopathic Cough

Intervention(s)

Drug: XEN-D0501

Drug: Placebo

Primary Outcome(s)

Change from baseline at the end of each treatment period in objective daytime cough frequency on XEN-D0501 compared to placebo [Time Frame: 12 weeks]

Secondary ID(s)

XEN-D0501-CL-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ario Pharma Ltd