Acute Pain Clinical Trial
Official title:
A Pilot Study Of The Efficacy Of WafermineTM Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy
To evaluate the safety and effectiveness of Wafermine administered with and without an opioid medication for acute pain following bunionectomy surgery.
This is a Phase 2, randomised, double-blind, double-dummy, placebo-controlled evaluation of
the analgesic efficacy and safety of WafermineTM alone and in combination with low-dose
oxycodone in adult subjects who experience post-operative pain after undergoing primary
unilateral bunionectomy. The study will randomise sufficient subjects to have 72 completed
subjects at 1 site.
Study subjects will receive multiple doses of study medication over a 14 hour period and
will be asked to complete pain and relief assessments as well as tolerability questionnaires
over a 24 hour period.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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