NCT02233699

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

July 15, 2015

Status Verified

July 1, 2015

Enrollment Period

10 months

First QC Date

August 29, 2014

Last Update Submit

July 14, 2015

Conditions

Chronic Idiopathic Cough

Outcome Measures

Primary Outcomes (1)

  • Change from baseline at the end of each treatment period in objective daytime cough frequency on XEN-D0501 compared to placebo

    12 weeks

Study Arms (2)

XEN-D0501

EXPERIMENTAL

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

Drug: XEN-D0501

Placebo to Match

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

XEN-D0501DRUG
XEN-D0501
PlaceboDRUG
Placebo to Match

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Belfast City Hospital

Belfast, BT9 7AB, Ireland

Location

University Hospital of South Manchester

Manchester, M23 9LT, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2014

First Posted

September 8, 2014

Study Start

July 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 15, 2015

Record last verified: 2015-07

Locations

IE(1)GB(1)