Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000248369
Ethics application status
Approved
Date submitted
30/04/2008
Date registered
15/05/2008
Date last updated
10/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of Gabapentin in the treatment of refractory chronic dry cough.
Scientific title
The role of Gabapentin in the treatment of refractory chronic dry cough: A randomised double-blind placebo-controlled study.
Secondary ID [1] 280045 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic cough 3098 0
Condition category
Condition code
Respiratory 3257 3257 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
300 mg of oral Neurontin once per day, then increased to 600mg/d for second day, then 900mg/d for third day upto maximum tolerable dose of 1800mg/day for ten weeks.
Intervention code [1] 2840 0
Treatment: Drugs
Comparator / control treatment
placebo-lactose (sugar pill)
Control group
Placebo

Outcomes
Primary outcome [1] 4144 0
Improvement in cough quality of life by Leicester Cough Questionnaire (LCQ)
Timepoint [1] 4144 0
baseline, during treatment visit (week 8) end of treatment visit (week 12) and post treatment visit (week 16).
Secondary outcome [1] 296293 0
Decrease in cough reflex senstivity
Timepoint [1] 296293 0
baseline, during treatment visit (week 8), end of treatment visit (week 12) and post treatment visit (week 16).
Secondary outcome [2] 318796 0
Decrease in cough frequency by cough monitor recording
Timepoint [2] 318796 0
baseline, during treatment visit (week 8), end of treatment visit (week 12) and post treatment visit (week 16).
Secondary outcome [3] 318797 0
Improvement in cough severity by Cough visual analogue scale (vas)
Timepoint [3] 318797 0
baseline, during treatment visit (week 8), end of treatment visit (week 12) and post treatment visit (week 16).

Eligibility
Key inclusion criteria
Persistent non-productive cough of more than 8 weeks duration,
Male or female between ages of 18 and 80 years,
Non-smoker or ex-smoker with less than 10 pack years,
To have been well during the 4 weeks prior to study entry,
Informed consent obtained.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Productive cough,
Current smoker,
Smoking history >10 pack years,
Pregnancy/breast feeding,
Other respiratory disease, eg: bronchiectasis, COPD.
Inability to attend study visits
Respiratory tract infection during month prior to randomisation
Impaired liver function at Visit 1 as shown by Aspartate aminotransferase (AST), an enzyme normally present in liver and heart cells and alanine aminotransferase (ALT). If the liver is injured, the liver cells spill the enzymes into blood, raising the enzyme levels in the blood and signaling liver damage.
Therefore, an AST, ALT, alkaline phosphatase or total bilirubin greater than 2 times the upper limit of normal will exclude a participant.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation concealment-central randomisation by computer to pharmacy for active or placebo allocation to subject whois along with the investigators blinded to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/05/2008
Actual
15/10/2008
Date of last participant enrolment
Anticipated
Actual
1/09/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 288337 0
Government body
Name [1] 288337 0
NHMRC CCRE PhD Scholarship
Country [1] 288337 0
Australia
Funding source category [2] 288338 0
Government body
Name [2] 288338 0
NHMRC Project Grant
Country [2] 288338 0
Australia
Primary sponsor type
Hospital
Name
Hunter New England Area Health Service
Address
Lookout Road,
New Lambton Heights NSW 2305.
Country
Australia
Secondary sponsor category [1] 2991 0
None
Name [1] 2991 0
Address [1] 2991 0
Country [1] 2991 0
Other collaborator category [1] 278698 0
Individual
Name [1] 278698 0
Dr Surinder S Birring
Address [1] 278698 0
Department of Respiratory Medicine,

King's College Hospital,

Denmark Hill,

London,

SE5 9RS
Country [1] 278698 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5371 0
Hunter New England Research Ethics Unit
Ethics committee address [1] 5371 0
Ethics committee country [1] 5371 0
Australia
Date submitted for ethics approval [1] 5371 0
Approval date [1] 5371 0
06/05/2008
Ethics approval number [1] 5371 0
08/03/19/3.04

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28560 0
Prof Peter G Gibson
Address 28560 0
Level 2 West Wing, HMRI
Lot 1, Kookaburra Circuit
New Lambton Heights NSW 2305.
Country 28560 0
Australia
Phone 28560 0
+61240420142
Fax 28560 0
+61240420046
Email 28560 0
[email protected]
Contact person for public queries
Name 11717 0
Nicole M Ryan
Address 11717 0
Clinical Toxicology Research Group, Level 5 New Med Building
Calvary Mater Newcastle, Waratah NSW 2298.
Country 11717 0
Australia
Phone 11717 0
+61249211312
Fax 11717 0
+61240143873
Email 11717 0
[email protected]
Contact person for scientific queries
Name 2645 0
Peter G Gibson
Address 2645 0
Level 2 West Wing, HMRI
Lot 1 Kookaburra Circuit
New Lambton Heights NSW 2305.
Country 2645 0
Australia
Phone 2645 0
+612 40420142
Fax 2645 0
+612 40420046
Email 2645 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseArnold's nerve cough reflex: Evidence for chronic cough as a sensory vagal neuropathy.2014https://dx.doi.org/10.3978/j.issn.2072-1439.2014.04.22
N.B. These documents automatically identified may not have been verified by the study sponsor.