Status:
TERMINATED
Phase II Open-Label Pilot Study of V3381 in Chronic Cough
Lead Sponsor:
Vernalis (R&D) Ltd
Collaborating Sponsors:
Manchester University NHS Foundation Trust
Conditions:
Cough
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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-excita...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01401673
Start Date
October 1 2009
End Date
August 1 2010
Last Update
July 25 2011
Active Locations (1)
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1
South Manchester University Hospital
Manchester, United Kingdom, M23 9LT