Completed

NCT Number: NCT02233699

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

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.

Completed

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Key information

Conditions

Chronic Idiopathic Cough

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Belfast City Hospital, Belfast, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XEN-D0501

Drug

Placebo

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Xention Ltd

Industry

Collaborators

Ario Pharma Ltd

Registry information

Official study 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.

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Sep 8, 2014
Registry last updated: Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.