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

NCT ID: NCT01401673

Last Updated: 2011-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-08-31

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].

Conditions

Cough

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Indantadol

Titration

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

Vernalis (R&D) Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Vernalis (R&D) Ltd

Principal Investigators

Ashley Woodcock, Prof.

Role: PRINCIPAL_INVESTIGATOR

South Manchester University Hospital

Locations

South Manchester University Hospital

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

V001

Identifier Type: -

Identifier Source: org_study_id