NCT01401673TerminatedPhase 2
Phase II Open-label Pilot Study of V3381, a Novel N-Methyl-D-Aspartate Receptor Antagonist, in Chronic Cough Patients Attending a Specialist Clinic
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Vernalis (R&D) Ltd
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Objective cough frequency at 8 weeks compared to baseline.
Study Overview
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].
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Objective cough frequency at 8 weeks compared to baseline.
Time Frame: 8 Weeks
Secondary Outcomes
- Change in objective cough frequency at 4 weeks.(4 Weeks)
- Change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) at 4 and 8 weeks.(4 and 8 Weeks)
- Change in Global Rating of Change Scale at 1 week, 2 weeks, 4 weeks and 8 weeks(1 Week, 2 Weeks, 4 Weeks and 8 Weeks)
Investigators
Study Sites (2)
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