Phase II Open-Label Pilot Study of V3381 in Chronic Cough

Study Description

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Brief Summary:

The investigators hypothesise that cough reflex hypersensitivity, demonstrated in chronic cough patients, is due to a phenomenon known as central sensitisation. Central sensitisation is a hyper-excitability of the sensory nerves as they join the central nervous system, and is believed to be mediated by the N-Methyl-D-Aspartate (NMDA) receptor[1-3].

Condition or disease	Intervention/treatment	Phase
Cough	Drug: Indantadol	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Open-label Pilot Study of V3381, a Novel N-Methyl-D-Aspartate Receptor Antagonist, in Chronic Cough Patients Attending a Specialist Clinic
Study Start Date :	October 2009
Actual Primary Completion Date :	August 2010
Actual Study Completion Date :	August 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:

Drug: Indantadol
Titration

Outcome Measures

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Primary Outcome Measures :

1. Objective cough frequency at 8 weeks compared to baseline. [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :

1. Change in objective cough frequency at 4 weeks. [ Time Frame: 4 Weeks ]
2. Change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) at 4 and 8 weeks. [ Time Frame: 4 and 8 Weeks ]
3. Change in Global Rating of Change Scale at 1 week, 2 weeks, 4 weeks and 8 weeks [ Time Frame: 1 Week, 2 Weeks, 4 Weeks and 8 Weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Male or female 18-75 years of age
• Females must be of non child-bearing potential
• Chronic Cough ( > 8 weeks)
• Normal Chest X-ray
• Normal Lung Function
• Idiopathic or treatment resistant cough-

Exclusion Criteria:

• Recent upper respiratory tract infection (<4 weeks)
• Pregnancy/breast-feeding
• Current smokers or ex-smokers with <6 months abstinence or cumulative history of >10 pack years
• Current treatment with ACE inhibitors.
• Drug or alcohol abuse
• Uncontrolled hypertension (i.e., >140/90 mmHg despite adequate medical therapy).
• Any cardiovascular condition that would be a contra-indication to the use of sympathomimetic amines (e.g. active angina).
• Any clinically significant neurological disorder
• Prior renal transplant, current renal dialysis.
• Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study.
• Increased risk of seizures.
• Any malignancy in the past 2 years (with the exception of basal cell carcinoma).
• Use of opioids, anticonvulsants, antidepressants (particularly MAO inhibitors).
• Any clinically significant abnormal laboratory test result(s).
• Serum creatinine laboratory value greater than 1.5 x upper limit of normal (ULN) reference range (after adjustment for age) or estimated creatinine clearance <60 mL/min.
• Total bilirubin greater than upper limit of normal reference range (with the exception of Gilbert's Syndrome) and/or alanine transaminase (ALT) >1.5 times upper limit of normal reference ranges (after adjustment for age).

Contacts and Locations

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Locations

United Kingdom
South Manchester University Hospital
Manchester, United Kingdom, M23 9LT

Sponsors and Collaborators

Vernalis (R&D) Ltd

Manchester University NHS Foundation Trust

Investigators

Principal Investigator:	Ashley Woodcock, Prof.	South Manchester University Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Development Director, Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier:	NCT01401673 History of Changes
Other Study ID Numbers:	V001
First Posted:	July 25, 2011
Last Update Posted:	July 25, 2011
Last Verified:	July 2011

Keywords provided by Vernalis (R&D) Ltd:

Chronic Cough; Indantadol

Additional relevant MeSH terms:

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms