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CoughPhase 2NCT01401673

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

A Phase 2 study testing Indantadol in people with Cough, run by Vernalis (R&D) Ltd at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cough
What is being tested?
Indantadol
How many people
12 participants
Where
1 siteUnited Kingdom
Study dates
Oct 2009to Aug 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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-

Who cannot join

  • 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).
Show all 16Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • South Manchester University Hospital

    Manchester, M23 9LT

Other trials in United Kingdom

About this study

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

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
Being tested
Indantadol
Keywords
Chronic Cough, Indantadol
Medical subject headings
Cough, Chronic Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IndantadolDrug

    Titration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective cough frequency at 8 weeks compared to baseline.

    Measured: 8 Weeks

Secondary outcomes (3)

  1. Change in objective cough frequency at 4 weeks.

    Measured: 4 Weeks

  2. Change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) at 4 and 8 weeks.

    Measured: 4 and 8 Weeks

  3. Change in Global Rating of Change Scale at 1 week, 2 weeks, 4 weeks and 8 weeks

    Measured: 1 Week, 2 Weeks, 4 Weeks and 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2011 (estimated)
  2. Study startOct 2009
  3. Primary completionAug 2010
  4. Study completionAug 2010

Why it stopped: Lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01401673
Sponsor's protocol ID
V001
Status last verified
Jul 2011
First submitted
21 Jul 2011
Last updated
25 Jul 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Indantadol in people with Cough, run by Vernalis (R&D) Ltd at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective cough frequency at 8 weeks compared to baseline. (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01401673.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2011.

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