Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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3 August 2015 |
Main ID: |
NCT02233699 |
Date of registration:
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29/08/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Study to Assess the Efficacy of XEN-D0501 in Reducing the Cough Frequency in Patients With Chronic Idiopathic Cough
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Scientific title:
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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. |
Date of first enrolment:
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July 2014 |
Target sample size:
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18 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02233699 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Ireland
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United Kingdom
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic Idiopathic Cough
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Intervention(s)
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Drug: XEN-D0501
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Drug: Placebo
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Primary Outcome(s)
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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]
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Secondary ID(s)
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XEN-D0501-CL-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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