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Trial from ANZCTR

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

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 13/11/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12617001629325

Date registered

13 December 2017

Health condition

Pain, Wounds

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales, Queensland, Victoria

Recruitment status

Recruiting

Anticipated date of first participant enrolment

13 December 2017

Ethics application status

Approved

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.

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

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

Contact details and further information

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

Contact person for information and recruitment

Dr Heather Giles
Vapogenix, Inc.
8285 El Rio Street, Suite 170
Houston, TX 77054
United States of America
+1 713 7483903
hgiles@vapogenix.com