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

Vernalis Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Cough

Treatments

Drug: Indantadol

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01401673

V001

Details and patient eligibility

About

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].

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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).