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Trial registered on ANZCTR


Registration number
ACTRN12617001629325
Ethics application status
Approved
Date submitted
18/11/2017
Date registered
13/12/2017
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Analgesic Efficacy, Safety and Tolerability of VPX638 Administered Topically on a Single Study Occasion, to Patients with Painful Wounds
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Analgesic Efficacy, Safety and Tolerability of VPX638 Administered Topically on a Single Study Occasion, to Patients with Painful Wounds
Secondary ID [1] 292202 0
VAP638-001
Universal Trial Number (UTN)
U1111-1197-6971
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 304044 0
Wounds 304045 0
Condition category
Condition code
Anaesthesiology 303369 303369 0 0
Pain management
Skin 304880 304880 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomized, double-blind, parallel-group, placebo-controlled study in patients with painful wounds. The study will have three phases: Screening Phase, Treatment Phase and Follow-Up Phase. The maximum study duration is 14 days. Eligible patients will be randomized to receive either VPX638 (100% neat VPX638) or placebo. Study drug (5 mL dose volumes) will be applied topically, twice on a single study occasion. The first dose will be applied to the wound following removal of the dressing. The second dose will be applied approximately 30-60 minutes after the first dose, following wound cleaning and/or debridement.

The study is designed to evaluate the analgesic efficacy, safety and tolerability of VPX638 when applied to painful wounds. The analgesic effect on rest pain and on pain during the wound cleansing/debridement procedure (performed 15-30 minutes after the first drug application) will be evaluated.
Intervention code [1] 298644 0
Treatment: Drugs
Comparator / control treatment
0.9% sodium chloride
Control group
Placebo

Outcomes
Primary outcome [1] 302803 0
The primary efficacy endpoint for this study is the analgesic effect of VPX638 during the wound care procedure by comparison of the average Numeric Pain Rating Scale Score of VPX638 and placebo. Assessments will utilize an 11-unit Numerical Rating Scale (NRS) score where 0 represents "No Pain" and 10 represents the "Worst Pain You Can Imagine".
Timepoint [1] 302803 0
Assessed immediately following cleansing and/or debridement
Secondary outcome [1] 337065 0
Time to onset of analgesic action assessed using an 11-unit Numerical Rating Scale (NRS) score where 0 represents "No Pain" and 10 represents the "Worst Pain You Can Imagine"
Timepoint [1] 337065 0
At 5, 10 and 15 minutes after 1st drug application
Secondary outcome [2] 337066 0
Change from Baseline in Numeric Pain Rating Scale Score within 15 minutes after the first study drug administration: comparison between VPX638 and placebo. Assessments will utilize an 11-unit Numerical Rating Scale (NRS) score where 0 represents "No Pain" and 10 represents the "Worst Pain You Can Imagine".
Timepoint [2] 337066 0
15 minutes after the administration of study drug
Secondary outcome [3] 337067 0
Duration of analgesic action of VPX638 assessed using an 11-unit Numerical Rating Scale (NRS) score where 0 represents "No Pain" and 10 represents the "Worst Pain You Can Imagine". Scores will be recorded in a patient diary.
Timepoint [3] 337067 0
At 1, 2, 4, 6, 8, 12, 18 and 24 hours after 2nd drug application
Secondary outcome [4] 340843 0
Safety and tolerability will be assessed by various measures including AEs, clinical laboratory results, physical exam, vital signs and local wound assessment. Local site reactions (Erythema, Edema, Papules/vesicular eruptions, Pruritus, Urticaria, etc) on wound bed, wound margins and surrounding skin will be evaluated and graded (absent, mild, moderate, severe).
Timepoint [4] 340843 0
Local wound site reaction assessments will be performed on the treatment visit, just prior to and 15 min after first drug administration, and at the follow-up visit (3-7 days after treatment visit). Vital signs will be assessed at screening visit, at treatment visit (just prior to and 15 min after first drug application, and at approx. 1 hr after second drug application) and at the follow-up visit (3-7 days after treatment visit). Physical exam will be performed at screening visit, treatment and follow-up visits. Clinical labs will be performed at screening and follow-up visit (3-7 days after treatment visit).

Eligibility
Key inclusion criteria
Presence of at least one painful wound that meets the following criteria:
a. Wound size of 100 cm2 or less
b. Wound open for at least 14 days
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History or family history of life-threatening reaction to general anesthesia
2. Wounds resulting from burns
3. Wounds on the face, head or neck
4. Liver function tests no more than 1.5x the upper limit of normal

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 296740 0
Commercial sector/Industry
Name [1] 296740 0
Vapogenix Australia Pty Ltd
Address [1] 296740 0
C/O Cedar Pacific (Pamoja Capital)
Level 15
1 Eagle Street
Brisbane Queensland 4000
Country [1] 296740 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Vapogenix Australia Pty Ltd
Address
C/O Cedar Pacific (Pamoja Capital)
Level 15
1 Eagle Street
Brisbane Queensland 4000
Country
Australia
Secondary sponsor category [1] 295712 0
None
Name [1] 295712 0
Address [1] 295712 0
Country [1] 295712 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297967 0
Ethics committee address [1] 297967 0
Ethics committee country [1] 297967 0
Australia
Date submitted for ethics approval [1] 297967 0
Approval date [1] 297967 0
25/10/2017
Ethics approval number [1] 297967 0

Summary
Brief summary
This is a randomized, double-blind, parallel-group, placebo-controlled study in patients with painful wounds, designed to evaluate the analgesic effect of VPX638 applied topically to the wound. Each participant will receive VPX638 or placebo topically, twice on a single study occasion. Analgesic efficacy, tolerability, and safety of VPX638 will be assessed.
Trial website
Trial related presentations / publications
Public notes
Heidelberg Repatriation Hospital, Heidelberg West, Ivanhoe, VIC
Dr. Paul Yates / Dr. Michael Woodward / Nikki Frescos
+61 03 9479 5832 or +61 03 9496 4232 or +61 03 9496 5000

The Royal Melbourne Hospital, Parkville, VIC
Dr. Rebecca Iseli / Sarah Sage
+61 03 8387 2712

The Alfred Hospital, Prahran, VIC
Dr. Geoff Cox / William McGuiness
+61 03 9479 6743

Wollongong Hospital, Wollongong, NSW
Dr. Spiros Miyakis / Sarah Gallagher / Julie Ferguson
+61 02 4221 4333

Pendlebury Research, Adamstown, NSW
Dr. Geoff Oldfield / Paula Abrego
+61 2 4902 5162

Dr. P M Aldons Private Practice Clinic
The Prince Charles Hospital, Chermside, QLD
+61 07 3139 4177

Mackay Institute of Research and Innovation
Mackay Hospital and Health Service, Mackay, QLD
Dr. Casper Pretorius / Karen Pretorius
+61 7 4885 6785 or +61 7 4885 7922

The Townsville Hospital, Douglas, QLD
Dr. Jonathan Golledge / Lisan Yip
+61 07 4433 1739

Contacts
Principal investigator
Name 75610 0
Dr Paul Yates
Address 75610 0
Austin Health
Study Road
Heidelberg West, VIC, Australia 3081
Country 75610 0
Australia
Phone 75610 0
+61 3 9496 2987
Fax 75610 0
Email 75610 0
paul.yates@austin.org.au
Contact person for public queries
Name 75611 0
Dr Heather Giles
Address 75611 0
Vapogenix, Inc.
8285 El Rio Street, Suite 170
Houston, TX 77054
Country 75611 0
United States of America
Phone 75611 0
+1 713 7483903
Fax 75611 0
Email 75611 0
hgiles@vapogenix.com
Contact person for scientific queries
Name 75612 0
Dr Heather Giles
Address 75612 0
Vapogenix, Inc.
8285 El Rio Street, Suite 170
Houston, TX 77054
Country 75612 0
United States of America
Phone 75612 0
+1 713 7483903
Fax 75612 0
Email 75612 0
hgiles@vapogenix.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable