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CompletedNCT02233699Updated Jul 15, 2015

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

A Phase 2 interventional study of XEN-D0501 and Placebo in Chronic Idiopathic Cough, sponsored by Xention Ltd. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-15.

Sponsored by Xention Ltd · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Idiopathic Cough

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03

In context

Cough

346 studies on the registry are indexed under Cough; 71 are open to participants now.

This study's enrollment of 18 is below the median of 70 across 263 interventional studies indexed under Cough.

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Lead sponsor

Xention Ltd is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Clinically significant medical history
  • Abnormal laboratory results, ECGs or vital signs
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    XEN-D0501

    4mg BID Days 1-13, 4mg once daily (OD) Day 14

    Drug: XEN-D0501

  • Placebo comparator
    Placebo to Match

    BID Days 1-13, once daily (OD) Day 14

    Drug: Placebo

Interventions

  • DrugXEN-D0501
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

2 sites
  • Belfast City Hospital
    Belfast, BT9 7AB, Ireland
  • University Hospital of South Manchester
    Manchester, M23 9LT, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02233699
Lead sponsor
Xention Ltd
Collaborators
Ario Pharma Ltd
Responsible party
Sponsor
First posted
Sep 8, 2014
Start date
Jul 2014
Primary completion
May 2015
Completion
May 2015
Last update
Jul 15, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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