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

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ClinicalTrials.gov Identifier: NCT01401673
Recruitment Status : Terminated (Lack of efficacy)
First Posted : July 25, 2011
Last Update Posted : July 25, 2011
Sponsor:
Collaborator:
Manchester University NHS Foundation Trust
Information provided by:
Vernalis (R&D) Ltd

Study Description
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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].

Condition or disease Intervention/treatment Phase
Cough Drug: Indantadol Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arms and Interventions
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Intervention Details:
  • Drug: Indantadol
    Titration

Outcome Measures
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Primary Outcome Measures :
  1. Objective cough frequency at 8 weeks compared to baseline. [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. Change in objective cough frequency at 4 weeks. [ Time Frame: 4 Weeks ]
  2. Change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) at 4 and 8 weeks. [ Time Frame: 4 and 8 Weeks ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401673


Locations
United Kingdom
South Manchester University Hospital
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Vernalis (R&D) Ltd
Manchester University NHS Foundation Trust
Investigators
Principal Investigator: Ashley Woodcock, Prof. South Manchester University Hospital
More Information
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Responsible Party: Development Director, Vernalis (R&D) Ltd
ClinicalTrials.gov Identifier: NCT01401673     History of Changes
Other Study ID Numbers: V001
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011

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