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

This study has been terminated.
(Lack of efficacy)
Sponsor:
Collaborator:
University Hospital of South Manchester NHS Foundation Trust
Information provided by:
Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier:
NCT01401673
First received: July 21, 2011
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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].


Condition Intervention Phase
Cough
Drug: Indantadol
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Vernalis (R&D) Ltd:

Primary Outcome Measures:
  • Objective cough frequency at 8 weeks compared to baseline. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in objective cough frequency at 4 weeks. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
  • Change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) at 4 and 8 weeks. [ Time Frame: 4 and 8 Weeks ] [ Designated as safety issue: No ]
  • Change in Global Rating of Change Scale at 1 week, 2 weeks, 4 weeks and 8 weeks [ Time Frame: 1 Week, 2 Weeks, 4 Weeks and 8 Weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: October 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Indantadol
    Titration
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401673

Locations
United Kingdom
South Manchester University Hospital
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Vernalis (R&D) Ltd
University Hospital of South Manchester NHS Foundation Trust
Investigators
Principal Investigator: Ashley Woodcock, Prof. South Manchester University Hospital
  More Information

No publications provided

Responsible Party: Development Director, Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier: NCT01401673     History of Changes
Other Study ID Numbers: V001
Study First Received: July 21, 2011
Last Updated: July 22, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Vernalis (R&D) Ltd:
Chronic Cough
Indantadol

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
N-Methylaspartate
Excitatory Amino Acid Agonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014