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

NCT01401673 | Terminated Phase 2

• 1 other identifier: V001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic Cough; Indantadol

Outcome Measures

Primary Outcomes (1)

• Objective cough frequency at 8 weeks compared to baseline.

  8 Weeks

Secondary Outcomes (3)

• 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

Interventions

Indantadol DRUG

Titration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vernalis (R&D) Ltd: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

South Manchester University Hospital

Manchester, M23 9LT, United Kingdom

Location

MeSH Terms

Conditions

Cough; Chronic Cough

Interventions

indantadol

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashley Woodcock, Prof.

  South Manchester University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 25, 2011
• Study Start: October 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

GB (1)