A Study to Assess the Efficacy of XEN-D0501 in Reducing t... | NCT02233686

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

NCT02233686

Sponsor

Xention Ltd

Status

Completed

Last Update Posted

Jul 15, 2015Estimated

Enrollment

27Actual

Phase

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

XEN-D0501
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Aug 29, 2014

First Submission Date that Met QC Criteria

Sep 3, 2014

First Posted Date

Sep 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2015

Last Update Posted Date

Jul 15, 2015Estimated

Name	Class
Ario Pharma Ltd	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 obstructive pulmonary disease (COPD).

The effectiveness of XEN-D0501 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, Clinical COPD Questionnaire (CCQ), Leicester Cough Questionnaire (LCQ), and St George's Respiratory Questionnaire (SGRQ-C) will be evaluated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
XEN-D0501	Drug		XEN-D0501
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline at the end of each treatment period in objective daytime cough frequency		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male/female subjects aged 40 or over with COPD

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medicines Evaluation Unit		Manchester		M23 9QZ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided