Back to resultsA Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough
Primary Purpose
Chronic Idiopathic Cough
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
XEN-D0501
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Cough
Eligibility 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
Sites / Locations
- Belfast City Hospital
- University Hospital of South Manchester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
XEN-D0501
Placebo to Match
Arm Description
4mg BID Days 1-13, 4mg once daily (OD) Day 14
BID Days 1-13, once daily (OD) Day 14
Outcomes
Primary Outcome Measures
Change from baseline at the end of each treatment period in objective daytime cough frequency on XEN-D0501 compared to placebo
Secondary Outcome Measures
Full Information
NCT ID
NCT02233699
First Posted
August 29, 2014
Last Updated
July 14, 2015
Sponsor
Xention Ltd
Collaborators
Ario Pharma Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02233699
Brief Title
A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xention Ltd
Collaborators
Ario Pharma Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Cough
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XEN-D0501
Arm Type
Experimental
Arm Description
4mg BID Days 1-13, 4mg once daily (OD) Day 14
Arm Title
Placebo to Match
Arm Type
Placebo Comparator
Arm Description
BID Days 1-13, once daily (OD) Day 14
Intervention Type
Drug
Intervention Name(s)
XEN-D0501
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
Ireland
Facility Name
University Hospital of South Manchester
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough
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