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Trial registered on ANZCTR


Registration number
ACTRN12607000201471
Ethics application status
Approved
Date submitted
27/03/2007
Date registered
12/04/2007
Date last updated
14/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the safety and effect of ACV1 on neuropathic pain in patients with diabetic peripheral neuropathic pain or post-herpetic neuralgia.
Scientific title
A randomised, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of subcutaneous doses of ACV1 in patients with diabetic peripheral neuropathic pain or post-herpetic neuralgia.
Secondary ID [1] 355 0
ACV103
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic peripheral neuropathy (DPN). 1725 0
Post-herpetic neuralgia (PHN). 1726 0
Post-herpetic neuralgia 2285 0
Condition category
Condition code
Metabolic and Endocrine 1816 1816 0 0
Diabetes
Neurological 1817 1817 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will receive ACV1 at a dose of 0.4 mg/kg, injected subcutaneously once per day for 21 days.
Intervention code [1] 1668 0
Treatment: Drugs
Comparator / control treatment
Patients will receive placebo, injected subcutaneously once per day for 21 days.
Control group
Placebo

Outcomes
Primary outcome [1] 2539 0
To determine the safety and tolerability of ACV1.
Timepoint [1] 2539 0
Laboratory testing at screening, pre-dose on Day 1 to Day 21 of treatment, and 7 days post-treatment.
Primary outcome [2] 2540 0
Vital sign monitoring
Timepoint [2] 2540 0
At screening, pre-dose, 30 minutes and 1 hour post-dose on all treatment days. On Day 1 and 21 of treatment, vital signs will also be monitored at 2, 4 and 8 hours post-dose.
Primary outcome [3] 2541 0
Electrocardiogram testing
Timepoint [3] 2541 0
Pre-dose, and at 2 and 4 hours post-dose on Day 1 and 21 of treatment; 7 days post-treatment.
Primary outcome [4] 2542 0
To determine the effect of ACV1 on pain rated using a visual analogue score (VAS).
Timepoint [4] 2542 0
During screening; pre-dose, 30 minutes, 1, 2, 4, and 8 hours post-dose on Day 1 of treatment; pre-dose and 1 hour post-dose on Days 2 to 20 of treatment; pre-dose, 30 minutes, 1, 2, 4, and 8 hours post-dose on Day 21 of treatment; 7 days post-treatment.
Primary outcome [5] 2543 0
To determine the effect of ACV1 on pain using a sleep interference score.
Timepoint [5] 2543 0
During screening; pre-dose on Day 1 to 21 of treatment; 7 days post-treatment.
Primary outcome [6] 2544 0
To determine the long-term effect of ACV1 on pain using a Short Form McGill Pain Questionnaire (SF-MPQ).
Timepoint [6] 2544 0
Pre-dose on Days 1 and 21 of treatment.
Primary outcome [7] 2545 0
To determine the long-term effect of ACV1 on pain using a Neuropathic Pain Symptom Inventory (NPSI).
Timepoint [7] 2545 0
Pre-dose on Days 1 and 21 of treatment.
Primary outcome [8] 2546 0
To determine the long-term effect of ACV1 on pain using the Clinician Global Impression of Change (CGIC) and the Patient Global Impression of Change (PGIC).
Timepoint [8] 2546 0
Post-dose on Day 21 of treatment.
Primary outcome [9] 2547 0
To determine the effect of ACV1 on touch sensitivity using von Frey filaments.
Timepoint [9] 2547 0
Pre-dose and at 30 minutes, 1, 2, 4, and 8 hours post-dose on Days 1 and 21 of treatment.
Primary outcome [10] 2548 0
To determine the single and multiple dose subcutaneous pharmacokinetics of ACV1.
Timepoint [10] 2548 0
Pre-dose and 10, 15, 20, 30, and 45 minutes post dose, and 1, 1.5, 2, 2.5, 3, 4, 6 and 8 hours post-dose on Days 1 and 21 of treatment.
Secondary outcome [1] 4390 0
'Nil'
Timepoint [1] 4390 0
'Nil'

Eligibility
Key inclusion criteria
Stable and controlled (haemoglobin A1c level less than 9.0% at screening) Type I or Type II diabetes mellitus, reporting at least 3 months of pain (VAS = 4cm for at least 5 days a week) due to DPN. OR, diagnosis of PHN, reporting at least 3 months of pain (VAS = 4cm for at least 5 days a week) since shingles vesicle crusting.Ability to provide written informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cardiac abnormality.Hypotension or hypertension.Organ dysfunction.Pain anywhere else of an equal or greater intensity of the neuropathic pain.

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)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation scheme will be produced by the trial statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All site and sponsor staff (staff administering the treatments, staff assessing the outcomes and staff analysing the results) and all subjects will be blinded to the study, with the exception of the trial pharmacist who will prepare the drug in a manner that maintains the blinding for all other staff.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
10/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 359 0
3128
Recruitment postcode(s) [2] 382 0
4029
Recruitment postcode(s) [3] 383 0
2065

Funding & Sponsors
Funding source category [1] 1969 0
Commercial sector/Industry
Name [1] 1969 0
Metabolic Pharmaceuticals Ltd.
Country [1] 1969 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Metabolic Pharmaceuticals Ltd.
Address
Level 3, 509 St Kilda Rd
Melbourne 3004
Country
Australia
Secondary sponsor category [1] 1780 0
None
Name [1] 1780 0
N/A.
Address [1] 1780 0
Country [1] 1780 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3664 0
Northern Sydney Central Coast Area Health Human Research Ethics Committee
Ethics committee address [1] 3664 0
Ethics committee country [1] 3664 0
Australia
Date submitted for ethics approval [1] 3664 0
26/03/2007
Approval date [1] 3664 0
05/04/2007
Ethics approval number [1] 3664 0
0612-249M
Ethics committee name [2] 4452 0
Eastern Health Research and Ethics Committee
Ethics committee address [2] 4452 0
Ethics committee country [2] 4452 0
Australia
Date submitted for ethics approval [2] 4452 0
24/04/2007
Approval date [2] 4452 0
17/05/2007
Ethics approval number [2] 4452 0
103/0607
Ethics committee name [3] 4453 0
Royal Brisbane Hospital Human Rssearch Ethics Committee
Ethics committee address [3] 4453 0
Ethics committee country [3] 4453 0
Australia
Date submitted for ethics approval [3] 4453 0
09/02/2007
Approval date [3] 4453 0
19/03/2007
Ethics approval number [3] 4453 0
2007/027
Ethics committee name [4] 4454 0
Upper South A Regional Ethics Committee
Ethics committee address [4] 4454 0
Ethics committee country [4] 4454 0
New Zealand
Date submitted for ethics approval [4] 4454 0
12/03/2007
Approval date [4] 4454 0
18/04/2007
Ethics approval number [4] 4454 0
URA/07/02/011

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

Contacts
Principal investigator
Name 27771 0
Address 27771 0
Country 27771 0
Phone 27771 0
Fax 27771 0
Email 27771 0
Contact person for public queries
Name 10857 0
Caroline Herd
Address 10857 0
Metabolic Pharmaceuticals Ltd
Level 3
509 St Kilda Rd
Melbourne VIC 3004
Country 10857 0
Australia
Phone 10857 0
+ 61 3 98605700
Fax 10857 0
+ 61 3 98605777
Email 10857 0
caroline.herd@metabolic.com.au
Contact person for scientific queries
Name 1785 0
Professor Michael Cousins
Address 1785 0
Pain Management & Research Centre
Level 9C
Main Block
Royal North Shore Hospital
St Leonards NSW 2065
Country 1785 0
Australia
Phone 1785 0
+ 61 2 99266451
Fax 1785 0
+ 61 2 99266548
Email 1785 0
MCousins@nsccahs.health.nsw.gov.au

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

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