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

Chronic Idiopathic Cough Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02233699
• Other study ID #: XEN-D0501-CL-04
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2014
• Last updated: July 14, 2015
• Start date: July 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Xention Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in reducing the daytime cough frequency in patients with chronic idiopathic cough.

The effectiveness of XEN-D0501 over placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale [VAS]), urge to cough (via VAS), global rating of change scale and Leicester Cough Questionnaire (LCQ) will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Cough
• Cough

Intervention

Drug:
• XEN-D0501

• Placebo

Locations

Country	Name	City	State
Ireland	Belfast City Hospital	Belfast
United Kingdom	University Hospital of South Manchester	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Xention Ltd	Ario Pharma Ltd

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline at the end of each treatment period in objective daytime cough frequency on XEN-D0501 compared to placebo		12 weeks	No