NCT02541396

A Study Of The Effectiveness Of Wafermine Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy

A Pilot Study Of The Efficacy Of WafermineTM Alone And In Combination With Opioids In Subjects Undergoing Bunionectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: iX Biopharma Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of Wafermine administered with and without an opioid medication for acute pain following bunionectomy surgery.

Detailed description

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.

Conditions

• Acute Pain

Interventions

Type	Name	Description
DRUG	Wafermine	35 or 70 mg ketamine in a sublingual wafer
DRUG	Oxycodone	5 mg oxycodone capsule
DRUG	Placebo	Placebo capsule or placebo wafer

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-09-04
• Last updated: 2016-02-23

Locations

1 site across 1 country: United States