None listed
Conditions
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.
Interventions
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 dr
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.
Sponsors
Vapogenix Australia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed