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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on November 25, 2014