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

Cough Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01401673
• Other study ID #: V001
• Status: Terminated
• Phase: Phase 2
• First received: July 21, 2011
• Last updated: July 22, 2011
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: July 2011
• Source: Vernalis (R&D) Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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].

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Indantadol
Titration

Locations

Country	Name	City	State
United Kingdom	South Manchester University Hospital	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Vernalis (R&D) Ltd	University Hospital of South Manchester NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective cough frequency at 8 weeks compared to baseline.		8 Weeks	No
Secondary	Change in objective cough frequency at 4 weeks.		4 Weeks	No
Secondary	Change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) at 4 and 8 weeks.		4 and 8 Weeks	No
Secondary	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	No