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

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Drug: Indantadol
- Objective cough frequency at 8 weeks compared to baseline. [ Time Frame: 8 Weeks ]
- Change in objective cough frequency at 4 weeks. [ Time Frame: 4 Weeks ]
- Change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) at 4 and 8 weeks. [ Time Frame: 4 and 8 Weeks ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

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
United Kingdom | |
South Manchester University Hospital | |
Manchester, United Kingdom, M23 9LT |
Principal Investigator: | Ashley Woodcock, Prof. | South Manchester University Hospital |
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 |